Amd §§6611 & 6612, Ed L; add Art 5 Title 7 §§590 - 593, Pub Health 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 health; makes related provisions.
STATE OF NEW YORK
________________________________________________________________________
1364--B
2025-2026 Regular Sessions
IN ASSEMBLY
January 9, 2025
___________
Introduced by M. of A. CLARK, SIMON, STIRPE, McDONALD, REYES, SMULLEN --
read once and referred to the Committee on Higher Education -- commit-
tee discharged, bill amended, ordered reprinted as amended and recom-
mitted to said committee -- again reported from said committee with
amendments, ordered reprinted as amended and recommitted to said
committee
AN ACT to amend the public health law and 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. Article 5 of the public health law is amended by adding a
2 new title 7 to read as follows:
3 TITLE VII
4 DENTAL LABORATORIES
5 Section 590. Definitions.
6 591. Dental laboratory registrations.
7 592. Nonresident dental laboratories.
8 593. Enforcement and penalties.
9 § 590. Definitions. As used in this title, the following terms shall
10 have the following meanings:
11 1. "Certified dental technician" shall mean a dental laboratory tech-
12 nician who is certified by the national board for certification in
13 dental laboratory technology, or a successor certifying body acceptable
14 to the department.
15 2. "Prescribing dentist" shall mean a licensed dentist who issues a
16 dental laboratory prescription or any other written or electronic
17 instrument directing the manufacture of or work to be performed on a
18 dental prosthesis, device, or appliance.
19 3. "Dental laboratory" shall mean a facility that engages in the
20 designing, making, repairing, altering, or supplying of artificial
21 restorations, substitutions, appliances, or materials for the correction
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD02645-04-5
A. 1364--B 2
1 of disease, loss, deformity, malposition, dislocation, fracture, injury
2 to the jaws, teeth, lips, gums, cheeks, palate, or associated tissues or
3 parts.
4 4. "Material content disclosure" shall mean a notice to the prescrib-
5 ing dentist that contains the name, physical address, and registration
6 number of the dental laboratory that received a prescription or any
7 other written or electronic instrument from a licensed dentist directing
8 the manufacture of or work to be performed on a dental prosthesis,
9 device, or appliance, and the city, state, and country of origin where
10 the work on the prosthesis, device or appliance was performed in whole
11 or in part or laboratories that manufactured or repaired the dental
12 prosthesis, either directly or indirectly, and the complete material
13 content information of all patient contact materials used in such dental
14 prosthesis, device or appliance, including whether the United States
15 food and drug administration cleared materials were used. Such notice
16 must be provided in a manner that can be easily entered into a patient
17 record.
18 5. "Responsible person" shall mean the person who:
19 (a) controls a majority interest in a dental laboratory; or
20 (b) is primarily responsible for the supervision of the day-to-day
21 operations of the dental laboratory.
22 6. "Work authorization" shall mean a written instrument by which a
23 dental laboratory delegates to another dental laboratory to perform work
24 on a dental prosthesis, device, or appliance, in whole or in part, as
25 authorized by a dental laboratory prescription from a licensed dentist.
26 § 591. Dental laboratory registrations. 1. (a) Any dental laboratory
27 operating, doing business, or intending to operate or do business in
28 this state must register with the department in a manner acceptable to
29 the department and in accordance with the department's regulations.
30 (b) A dental laboratory shall be considered operating or doing busi-
31 ness within this state if its work product is prepared for a prescribing
32 dentist pursuant to a prescription or work authorization originating
33 from an entity located within this state.
34 2. Any dental laboratory operating, doing business, or intending to
35 operate or do business within this state must submit an application for
36 registration of dental laboratory or renewal of registration of dental
37 laboratory to the department in a form provided by the department and
38 accompanied by a registration or renewal fee as provided in this
39 section. An application for registration or renewal of registration
40 must include:
41 (a) The name, mailing address, phone number, and email address of the
42 dental laboratory;
43 (b) The physical address of the dental laboratory, if different from
44 the mailing address of the dental laboratory;
45 (c) The name, mailing address, phone number, and email address of the
46 responsible person, or the name and license number of the supervising
47 dentist who is licensed under article one hundred thirty-three of the
48 education law;
49 (d) A statement that the dental laboratory meets accepted infection
50 control precaution practices as established by the department pursuant
51 to section two hundred thirty-a of this chapter;
52 (e) An acknowledgment by the responsible person or the supervising
53 dentist that the dental laboratory will provide a material content
54 disclosure to the prescribing dentist of all patient contact materials
55 that contain both the manufacturer and brand name, or the United States
56 food and drug administration registration number of all patient contact
A. 1364--B 3
1 materials contained in each restoration such that the dentist may
2 include those in the patient's record;
3 (f) An acknowledgment by the responsible person or the supervising
4 dentist who is licensed in this state that they will disclose to the
5 prescribing dentist the point of origin of the manufacture of the resto-
6 ration. If the restoration was partially or entirely manufactured by a
7 third-party provider, the point of origin disclosure must identify the
8 portion manufactured by a third-party provider and the city, state, and
9 country of the provider;
10 (g) The name of any person who works at least thirty hours per week in
11 the responsible person's dental laboratory and:
12 (i) Has successfully completed at least thirty-six hours of continuing
13 education in dental laboratory technology approved by the national board
14 for certification in dental laboratory technology, or a successor certi-
15 fying body acceptable to the department, during the thirty-six months
16 immediately preceding the application for registration or renewal of
17 registration; or
18 (ii) Is a certified dental technician in good standing;
19 (h) An acknowledgment by the responsible person or the supervising
20 dentist that the laboratory will continuously satisfy the requirements
21 of this section; and
22 (i) A registration or renewal fee, not to exceed one hundred and fifty
23 dollars, as determined by the department.
24 3. Upon approval of a registration for a dental laboratory, the
25 department shall assign the dental laboratory a registration number.
26 Such registration number must appear on any invoice from and all other
27 correspondence by a dental laboratory to the prescribing dentist.
28 4. A dental laboratory registration shall require renewal on a trien-
29 nial basis from the date of issuance. Registrations may be renewed with
30 the department upon receipt and approval of application materials as
31 required by subdivision two of this section.
32 5. (a) This section shall not apply to a dental laboratory operating
33 under the supervision of a practicing dentist licensed under article one
34 hundred thirty-three of the education law in a dental office or as a
35 part of a dental practice, provided that the laboratory does not perform
36 work for a prescribing dentist from outside of the supervising dentist's
37 dental practice or supervising dentist's office, or in an educational
38 institution as part of the institution's educational program, provided
39 that the dental laboratory does not routinely perform work for prescrib-
40 ing dentists from outside of the educational institution.
41 (b) A responsible person or employee of a dental laboratory may engage
42 in onsite consultation with a licensed dentist during a dental proce-
43 dure.
44 § 592. Nonresident dental laboratories. 1. The term "nonresident
45 dental laboratory" shall mean any dental laboratory as defined in subdi-
46 vision three of section five hundred ninety of this title that is
47 located outside of this state which has its work product prepared pursu-
48 ant to a prescription or any other written or electronic instrument from
49 a licensed dentist or work authorization originating from an entity
50 located within this state.
51 2. Any nonresident dental laboratory that ships, mails, or delivers
52 dental prostheses, devices or appliances to any other dental laboratory,
53 dental office, licensed dentist, and/or patient in this state pursuant
54 to a prescription or any other written or electronic instrument from a
55 licensed dentist or work authorization originating from an entity
56 located within this state shall be registered with the department.
A. 1364--B 4
1 3. Each nonresident dental laboratory that ships, mails, or delivers
2 dental prostheses, devices or appliances into this state shall designate
3 a resident agent in this state for service of process pursuant to rule
4 three hundred eighteen of the civil practice law and rules.
5 4. As a condition of registration, a nonresident dental laboratory
6 shall comply with the following requirements:
7 (a) Be in good standing in the state of residence;
8 (b) Maintain, in readily retrievable form, records of work product
9 shipped into this state;
10 (c) Supply, upon request, all information needed by the department to
11 carry out the department's responsibilities under the laws and rules and
12 regulations pertaining to nonresident dental laboratories;
13 (d) Comply with all statutory and regulatory requirements of the state
14 where the nonresident dental laboratory is located;
15 (e) Apply in the manner and form prescribed by the department pursuant
16 to the requirements of subdivision two of section five hundred ninety-
17 one of this title.
18 5. The department may adopt such regulations as appropriate to evalu-
19 ate registrations from dental laboratories that hold valid licenses,
20 registrations, certifications or their equivalent in another state or
21 country, provided the standards for granting licenses, registrations, or
22 certifications to such facilities are not less than the standards
23 required of dental laboratories otherwise registered pursuant to this
24 title.
25 § 593. Enforcement and penalties. 1. A registration issued pursuant to
26 this title may be revoked or suspended by the department on proof that
27 the responsible person or one or more persons in their employ:
28 (a) has been guilty of misrepresentation in obtaining the registration
29 or in the operation of the dental laboratory;
30 (b) has shipped, mailed, or delivered dental prostheses, devices or
31 appliances into this state performed in another dental laboratory with-
32 out designating the fact that such work product was performed by another
33 dental laboratory;
34 (c) has failed to renew any registration required by the provisions of
35 this title; or
36 (d) has not otherwise complied with the requirements of this title.
37 2. Any person or entity which owns or operates a dental laboratory and
38 does not hold a valid registration shall be liable for a civil penalty
39 not to exceed one thousand dollars for each day for the unregistered
40 operation of such laboratory.
41 3. Any violation of any other provision of this title shall be subject
42 to a fine of not more than one thousand dollars. A second or subsequent
43 violation shall be punishable by a fine of not more than two thousand
44 five hundred dollars.
45 § 2. Subdivision 1 of section 6611 of the education law, as amended by
46 chapter 576 of the laws of 2001, is amended to read as follows:
47 1. Except upon the written dental laboratory prescription of a
48 licensed dentist and except by the use of impressions, including but not
49 limited to digital intraoral scans or analog impressions, or casts made
50 by a licensed dentist, no dental laboratory shall furnish, supply,
51 construct, reproduce, place, adjust, or repair any dental prosthesis,
52 device, or appliance. A dental laboratory prescription shall be made out
53 in duplicate. It shall contain the registration number issued by the
54 department of health pursuant to title seven of article five of the
55 public health law and such other data as may be prescribed by the
56 commissioner's regulations. One copy shall be retained by the practi-
A. 1364--B 5
1 tioner of dentistry for a period of one year. The other copy shall be
2 issued to the person, firm or corporation engaged in filling dental
3 laboratory prescriptions, who or which shall each retain and file in
4 their respective offices or places of business their respective copies
5 for a period of one year.
6 § 3. Section 6612 of the education law, as added by chapter 332 of the
7 laws of 1985, is amended to read as follows:
8 § 6612. Identification of removable full or partial prosthetic
9 devices. 1. Except as provided [herein] in this section, every dentist
10 licensed in this state making or directing to be made a removable pros-
11 thetic denture, bridge, appliance or other structure to be used and worn
12 as a substitute for natural teeth, shall offer to the patient for whom
13 the prosthesis is intended the opportunity to have such prosthesis
14 marked with the patient's name or initials. Such markings shall be
15 accomplished at the time the prosthesis is made and the location and
16 methods used to apply or implant them shall be determined by the dentist
17 or the person acting on behalf of the dentist. Such marking shall be
18 permanent, legible and cosmetically acceptable.
19 2. Notwithstanding the foregoing, if in the judgment of the dentist or
20 the [person] dental laboratory registered pursuant to title seven of
21 article five of the public health law making the prosthesis, such iden-
22 tification is not practicable or clinically safe, the identification
23 marks may be omitted entirely.
24 3. The commissioner shall adopt rules and regulations and provide
25 standards necessary to carry out the provisions of this section.
26 § 4. This act shall take effect one year after it shall have become a
27 law. Effective immediately, the addition, amendment and/or repeal of any
28 rule or regulation necessary for the implementation of this act on its
29 effective date are authorized to be made and completed on or before such
30 effective date.
