Amd §§6611 & 6612, add §§6610-a, 6614 & 6615, Ed L
 
Relates to dental laboratories; defines terms; requires any dental laboratory operating, doing business, or intending to operate or do business in this state to register with the department of education; makes related provisions.
NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A9089
SPONSOR: Clark
 
TITLE OF BILL:
An act to amend the education law, in relation to dental laboratories
 
PURPOSE:
The purpose of this bill is to provide for increased safety and trans-
parency for New Yorkers and their dentists related to dental prostheses,
devices or appliances, and to provide for the registration of dental
laboratories.
 
SUMMARY OF PROVISIONS:
Section 1: Amends subdivision 1 of § 6611 of the education law to clari-
fy that prescriptions for dental impressions shall include digital
intraoral scans and analog impression, and to require dental laboratory
registration information to be included with dental laboratory
prescriptions.
Section 2: Amends § 6612 of the education law to clarify that dental
laboratories must comply with prosthetic identification marking require-
ments.
Section 3: Adds § 6610-A, to provide for definitions relating to the
provision of this act; adds § 6614, to provide for the registration of
dental laboratories doing business or intending to do business in New
York state and the requirements for such registrations; adds § 6615 to
provide for the registration of non-resident dental laboratories provid-
ing products into New York state and the requirements for such registra-
tion.
Section 4: provides that this act shall take effect one year after
becoming law, and provides the State Education Department with the
authority to promulgate rules and regulations and to implement such
other measures upon the act becoming a law
 
JUSTIFICATION:
The dental laboratory industry produces and provides dentures, crowns,
bridges, orthodontic appliances and other dental restorations for thou-
sands of New Yorkers each year. These important products and services
are integral to the improvement of patient health and the quality of
life for New Yorkers, every day. While New Yorkers and their dentists
assume the quality of these products and their constituent materials are
safe to use, there are few statutory protections in place to ensure they
are, in fact, manufactured in a safe environment and use quality materi-
als.
Currently, there is no requirement that a dental laboratory inform the
dentist of the materials used in a restoration or the point of origin of
manufacture. Because poorly made dental restorations can lead to a range
of health consequences for patients, and negative treatment and profes-
sional outcomes for their dentists, it is critical that there be greater
oversight and accountability and that dentists receive the information
they need to ensure the standard of care for their patients.
Moreover, growing demand for dental work in the United States has helped
create a robust market for both high-end as well as more economically
priced dental restoration products. Recenthave shown that nationwide
approximately. 25 percent of domestic dental laboratory sales, and 38
percent of dental restorations are manufactured overseas, evidenced by
the fact that there are foreign dental laboratories from 42 countries
currently registered with the U.S. Food and Drug Administration. While
the global market to provide these services and products has expanded,
awareness of the sourcing of dental restorations and their component
materials has not kept pace with the rate of change. The ability to have
a full understanding and confidence in the origin of dental restoration
materials is therefore vital to patients and dentists in ensuring better
health outcomes and safer restorations.
This legislation promotes modest, yet important, measures to improve
public health and consumer safety. By providing for improved product
transparency practitioners, establishing reasonable registration stand-
ards and accountability for dental laboratories and their products, this
legislation will ensure that dentists receive the information needed to
strengthen patient and health provider confidence and improve health
outcomes.
 
FISCAL IMPACT ON THE STATE:
None.
 
LEGISLATIVE HISTORY:
New bill.
 
EFFECTIVE DATE:
This act shall take effect one year after it shall have become law.
STATE OF NEW YORK
________________________________________________________________________
9089
IN ASSEMBLY
February 6, 2024
___________
Introduced by M. of A. CLARK -- read once and referred to the Committee
on Higher Education
AN ACT to amend the education law, in relation to dental laboratories
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Subdivision 1 of section 6611 of the education law, as
2 amended by chapter 576 of the laws of 2001, is amended to read as
3 follows:
4 1. Except upon the written dental laboratory prescription of a
5 licensed dentist and except by the use of impressions, including but not
6 limited to digital intraoral scans or analog impressions, or casts made
7 by a licensed dentist, no dental laboratory shall furnish, supply,
8 construct, reproduce, place, adjust, or repair any dental prosthesis,
9 device, or appliance. A dental laboratory prescription shall be made out
10 in duplicate. It shall contain the registration number issued by the
11 department and such other data as may be prescribed by the commission-
12 er's regulations. One copy shall be retained by the practitioner of
13 dentistry for a period of one year. The other copy shall be issued to
14 the person, firm or corporation engaged in filling dental laboratory
15 prescriptions, who or which shall each retain and file in their respec-
16 tive offices or places of business their respective copies for a period
17 of one year.
18 § 2. Section 6612 of the education law, as added by chapter 332 of the
19 laws of 1985, is amended to read as follows:
20 § 6612. Identification of removable full or partial prosthetic
21 devices. 1. Except as provided [herein] in this section, every dentist
22 licensed in this state making or directing to be made a removable pros-
23 thetic denture, bridge, appliance or other structure to be used and worn
24 as a substitute for natural teeth, shall offer to the patient for whom
25 the prosthesis is intended the opportunity to have such prosthesis
26 marked with the patient's name or initials. Such markings shall be
27 accomplished at the time the prosthesis is made and the location and
28 methods used to apply or implant them shall be determined by the dentist
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD11541-01-3
A. 9089 2
1 or the person acting on behalf of the dentist. Such marking shall be
2 permanent, legible and cosmetically acceptable.
3 2. Notwithstanding the foregoing, if in the judgment of the dentist or
4 the [person] dental laboratory making the prosthesis, such identifica-
5 tion is not practicable or clinically safe, the identification marks may
6 be omitted entirely.
7 3. The commissioner shall adopt rules and regulations and provide
8 standards necessary to carry out the provisions of this section.
9 § 3. The education law is amended by adding three new sections 6610-a,
10 6614, and 6615 to read as follows:
11 § 6610-a. Dental laboratories. For the purposes of sections sixty-six
12 hundred eleven, sixty-six hundred twelve, sixty-six hundred fourteen,
13 and sixty-six hundred fifteen of this article, the following terms shall
14 have the following meanings:
15 1. "Certified dental technician" shall mean a dental laboratory tech-
16 nician who is certified by the national board for certification in
17 dental laboratory technology.
18 2. "Prescribing dentist" shall mean a licensed dentist who issues a
19 dental laboratory prescription or any other written or electronic
20 instrument directing the manufacture of or work to be performed on a
21 dental prosthesis, device, or appliance.
22 3. "Dental laboratory" shall mean a facility that engages in the
23 designing, making, repairing, altering, or supplying of artificial
24 restorations, substitutions, appliances, or materials for the correction
25 of disease, loss, deformity, malposition, dislocation, fracture, injury
26 to the jaws, teeth, lips, gums, cheeks, palate, or associated tissues or
27 parts.
28 4. "Material content disclosure" shall mean a notice to the prescrib-
29 ing dentist that contains the name, physical address, and registration
30 number of the dental laboratory that received a prescription or any
31 other written or electronic instrument from a licensed dentist directing
32 the manufacture of or work to be performed on a dental prosthesis,
33 device, or appliance, and the city, state, and country of origin where
34 the work on the prosthesis, device or appliance was performed in whole
35 or in part or laboratories that manufactured or repaired the dental
36 prosthesis, either directly or indirectly, and the complete material
37 content information of all patient contact materials used in such dental
38 prosthesis, device or appliance, including whether the United States
39 food and drug administration cleared materials were used. Such notice
40 must be provided in a manner that can be easily entered into a patient
41 record.
42 5. "Work authorization" shall mean a written instrument by which a
43 dental laboratory delegates to another dental laboratory to perform work
44 on a dental prosthesis, device, or appliance, in whole or in part, as
45 authorized by a dental laboratory prescription from a licensed dentist.
46 § 6614. Dental laboratory registrations. 1. (a) Any dental laboratory
47 operating, doing business, or intending to operate or do business in
48 this state must register with the department in a manner acceptable to
49 the department and in accordance with the commissioner's regulations.
50 (b) A dental laboratory shall be considered operating or doing busi-
51 ness within this state if its work product is prepared for a prescribing
52 dentist pursuant to a prescription or work authorization originating
53 from an entity located within this state.
54 2. Any dental laboratory operating, doing business, or intending to
55 operate or do business within this state must submit an application for
56 registration of dental laboratory or renewal of registration of dental
A. 9089 3
1 laboratory to the department in a form provided by the department and
2 accompanied by a registration or renewal fee as provided in this
3 section. Applications for registration or renewals of registration must
4 include:
5 (a) The name, mailing address, phone number, and email address of the
6 dental laboratory;
7 (b) The physical address of the dental laboratory, if different from
8 the mailing address of the dental laboratory;
9 (c) The name, mailing address, phone number, and email address of the
10 responsible person, or, the name and license number of the supervising
11 dentist who is licensed under this article;
12 (d) A statement that the dental laboratory meets accepted infection
13 control precaution practices as established by the department of health
14 pursuant to section two hundred thirty-a of the public health law;
15 (e) An acknowledgment by the responsible person or the supervising
16 dentist that the dental laboratory will provide a material content
17 disclosure to the prescribing dentist of all patient contact materials
18 that contain both the manufacturer and brand name, or the United States
19 food and drug administration registration number of all patient contact
20 materials contained in each restoration such that the dentist may
21 include those in the patient's record;
22 (f) An acknowledgment by the responsible person or the supervising
23 dentist who is licensed in this state that he or she will disclose to
24 the prescribing dentist the point of origin of the manufacture of the
25 restoration. If the restoration was partially or entirely manufactured
26 by a third-party provider, the point of origin disclosure must identify
27 the portion manufactured by a third-party provider and the city, state,
28 and country of the provider;
29 (g) Materials documenting that the applicant or one of the applicant's
30 employees who works at least thirty hours per week in the applicant's
31 dental laboratory:
32 (i) Has successfully completed at least thirty-six hours of continuing
33 education in dental laboratory technology approved by the national board
34 for certification in dental laboratory technology or another certifying
35 body having certification or registration standards acceptable to the
36 commissioner during the thirty-six months immediately preceding their
37 application or renewal for registration, provided however, that such
38 education must be completed by an individual who works on the laboratory
39 premises; or
40 (ii) Is a certified dental technician in good standing;
41 (h) An acknowledgment by the responsible person or the supervising
42 dentist that the laboratory will continuously maintain a qualified owner
43 or employee satisfying the requirements of paragraph (g) of this
44 section; and
45 (i) A registration or renewal fee, not to exceed one hundred and fifty
46 dollars, as determined by the department.
47 3. Upon approval of a registration for a dental laboratory, the
48 department shall assign the dental laboratory a registration number.
49 Such registration number must appear on any invoice from and all other
50 correspondence by a dental laboratory to the prescribing dentist.
51 4. Dental laboratory registrations shall require renewal on a trienni-
52 al basis from the date of issuance. Registrations may be renewed with
53 the department upon receipt and approval of application materials as
54 required by subdivision two of this section.
55 5. (a) This section shall not apply to a dental laboratory operating
56 under the supervision of a practicing dentist licensed under this arti-
A. 9089 4
1 cle in a dental office or as a part of a dental practice, provided that
2 the laboratory does not perform work for a prescribing dentist from
3 outside of the supervising dentist's dental practice or supervising
4 dentist's office, or in an educational institution as part of the insti-
5 tution's educational program, provided that the dental laboratory does
6 not routinely perform work for prescribing dentists from outside of the
7 educational institution.
8 (b) A responsible person or employee of a dental laboratory may engage
9 in onsite consultation with a licensed dentist during a dental proce-
10 dure.
11 § 6615. Nonresident dental laboratories. 1. The term "nonresident
12 dental laboratory" shall mean any dental laboratory as defined in subdi-
13 vision three of section sixty-six ten-a of this article located outside
14 of this state which has its work product prepared pursuant to a
15 prescription or any other written or electronic instrument from a
16 licensed dentist or work authorization originating from an entity
17 located within this state.
18 2. Any nonresident dental laboratory that ships, mails, or delivers
19 dental prostheses, devices or appliances to any other dental laboratory,
20 dental office, licensed dentist, and/or patient in this state pursuant
21 to a prescription or any other written or electronic instrument from a
22 licensed dentist or work authorization originating from an entity
23 located within this state shall be registered with the department.
24 3. Each nonresident dental laboratory that ships, mails, or delivers
25 dental prostheses, devices or appliances into this state shall designate
26 a resident agent in this state for service of process pursuant to rule
27 three hundred eighteen of the civil practice law and rules.
28 4. As a condition of registration, a nonresident dental laboratory
29 shall comply with the following requirements:
30 (a) Be in good standing in the state of residence;
31 (b) Maintain, in readily retrievable form, records of work product
32 shipped into this state;
33 (c) Supply, upon request, all information needed by the department to
34 carry out the department's responsibilities under the laws and rules and
35 regulations pertaining to nonresident dental laboratories;
36 (d) Comply with all statutory and regulatory requirements of the state
37 where the nonresident dental laboratory is located;
38 (e) Apply in the manner and form prescribed by the department pursuant
39 to the requirements of subdivision two of section sixty-six hundred
40 fourteen of this article.
41 5. The commissioner may adopt such regulations as appropriate to eval-
42 uate registrations from dental laboratories that hold valid licenses,
43 registrations, certifications or their equivalent in another state or
44 country, provided the standards for granting licenses, registrations, or
45 certifications to such facilities are not less than the standards
46 required of dental laboratories otherwise registered pursuant to this
47 section.
48 § 4. This act shall take effect one year after it shall have become a
49 law. Effective immediately, the addition, amendment and/or repeal of any
50 rule or regulation necessary for the implementation of this act on its
51 effective date are authorized to be made and completed on or before such
52 effective date.