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--A
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
AN ACT to amend the education law and the public health 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 of health pursuant to title seven of article five of the
12 public health law and such other data as may be prescribed by the
13 commissioner's regulations. One copy shall be retained by the practi-
14 tioner of dentistry for a period of one year. The other copy shall be
15 issued to the person, firm or corporation engaged in filling dental
16 laboratory prescriptions, who or which shall each retain and file in
17 their respective offices or places of business their respective copies
18 for a period of one year.
19 § 2. Section 6612 of the education law, as added by chapter 332 of the
20 laws of 1985, is amended to read as follows:
21 § 6612. Identification of removable full or partial prosthetic
22 devices. 1. Except as provided [herein] in this section, every dentist
23 licensed in this state making or directing to be made a removable pros-
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD02645-02-5
A. 1364--A 2
1 thetic denture, bridge, appliance or other structure to be used and worn
2 as a substitute for natural teeth, shall offer to the patient for whom
3 the prosthesis is intended the opportunity to have such prosthesis
4 marked with the patient's name or initials. Such markings shall be
5 accomplished at the time the prosthesis is made and the location and
6 methods used to apply or implant them shall be determined by the dentist
7 or the person acting on behalf of the dentist. Such marking shall be
8 permanent, legible and cosmetically acceptable.
9 2. Notwithstanding the foregoing, if in the judgment of the dentist or
10 the [person] dental laboratory registered pursuant to title seven of
11 article five of the public health law making the prosthesis, such iden-
12 tification is not practicable or clinically safe, the identification
13 marks may be omitted entirely.
14 3. The commissioner shall adopt rules and regulations and provide
15 standards necessary to carry out the provisions of this section.
16 § 3. Article 5 of the public health law is amended by adding a new
17 title 7 to read as follows:
18 TITLE VII
19 DENTAL LABORATORIES
20 Section 590. Definitions.
21 591. Dental laboratory registrations.
22 592. Nonresident dental laboratories.
23 593. Enforcement and penalties.
24 § 590. Definitions. As used in this title, the following terms shall
25 have the following meanings:
26 1. "Certified dental technician" shall mean a dental laboratory tech-
27 nician who is certified by the national board for certification in
28 dental laboratory technology, or a successor certifying body acceptable
29 to the department.
30 2. "Prescribing dentist" shall mean a licensed dentist who issues a
31 dental laboratory prescription or any other written or electronic
32 instrument directing the manufacture of or work to be performed on a
33 dental prosthesis, device, or appliance.
34 3. "Dental laboratory" shall mean a facility that engages in the
35 designing, making, repairing, altering, or supplying of artificial
36 restorations, substitutions, appliances, or materials for the correction
37 of disease, loss, deformity, malposition, dislocation, fracture, injury
38 to the jaws, teeth, lips, gums, cheeks, palate, or associated tissues or
39 parts.
40 4. "Material content disclosure" shall mean a notice to the prescrib-
41 ing dentist that contains the name, physical address, and registration
42 number of the dental laboratory that received a prescription or any
43 other written or electronic instrument from a licensed dentist directing
44 the manufacture of or work to be performed on a dental prosthesis,
45 device, or appliance, and the city, state, and country of origin where
46 the work on the prosthesis, device or appliance was performed in whole
47 or in part or laboratories that manufactured or repaired the dental
48 prosthesis, either directly or indirectly, and the complete material
49 content information of all patient contact materials used in such dental
50 prosthesis, device or appliance, including whether the United States
51 food and drug administration cleared materials were used. Such notice
52 must be provided in a manner that can be easily entered into a patient
53 record.
54 5. "Responsible person" shall mean the person who:
55 (a) controls a majority interest in a dental laboratory; or
A. 1364--A 3
1 (b) is primarily responsible for the supervision of the day-to-day
2 operations of the dental laboratory.
3 6. "Work authorization" shall mean a written instrument by which a
4 dental laboratory delegates to another dental laboratory to perform work
5 on a dental prosthesis, device, or appliance, in whole or in part, as
6 authorized by a dental laboratory prescription from a licensed dentist.
7 § 591. Dental laboratory registrations. 1. (a) Any dental laboratory
8 operating, doing business, or intending to operate or do business in
9 this state must register with the department in a manner acceptable to
10 the department and in accordance with the department's regulations.
11 (b) A dental laboratory shall be considered operating or doing busi-
12 ness within this state if its work product is prepared for a prescribing
13 dentist pursuant to a prescription or work authorization originating
14 from an entity located within this state.
15 2. Any dental laboratory operating, doing business, or intending to
16 operate or do business within this state must submit an application for
17 registration of dental laboratory or renewal of registration of dental
18 laboratory to the department in a form provided by the department and
19 accompanied by a registration or renewal fee as provided in this
20 section. An application for registration or renewal of registration
21 must include:
22 (a) The name, mailing address, phone number, and email address of the
23 dental laboratory;
24 (b) The physical address of the dental laboratory, if different from
25 the mailing address of the dental laboratory;
26 (c) The name, mailing address, phone number, and email address of the
27 responsible person, or the name and license number of the supervising
28 dentist who is licensed under article one hundred thirty-three of the
29 education law;
30 (d) A statement that the dental laboratory meets accepted infection
31 control precaution practices as established by the department pursuant
32 to section two hundred thirty-a of this chapter;
33 (e) An acknowledgment by the responsible person or the supervising
34 dentist that the dental laboratory will provide a material content
35 disclosure to the prescribing dentist of all patient contact materials
36 that contain both the manufacturer and brand name, or the United States
37 food and drug administration registration number of all patient contact
38 materials contained in each restoration such that the dentist may
39 include those in the patient's record;
40 (f) An acknowledgment by the responsible person or the supervising
41 dentist who is licensed in this state that they will disclose to the
42 prescribing dentist the point of origin of the manufacture of the resto-
43 ration. If the restoration was partially or entirely manufactured by a
44 third-party provider, the point of origin disclosure must identify the
45 portion manufactured by a third-party provider and the city, state, and
46 country of the provider;
47 (g) The name of any person who works at least thirty hours per week in
48 the responsible person's dental laboratory and:
49 (i) Has successfully completed at least thirty-six hours of continuing
50 education in dental laboratory technology approved by the national board
51 for certification in dental laboratory technology, or a successor certi-
52 fying body acceptable to the department, during the thirty-six months
53 immediately preceding the application for registration or renewal of
54 registration; or
55 (ii) Is a certified dental technician in good standing;
A. 1364--A 4
1 (h) An acknowledgment by the responsible person or the supervising
2 dentist that the laboratory will continuously satisfy the requirements
3 of this section; and
4 (i) A registration or renewal fee, not to exceed one hundred and fifty
5 dollars, as determined by the department.
6 3. Upon approval of a registration for a dental laboratory, the
7 department shall assign the dental laboratory a registration number.
8 Such registration number must appear on any invoice from and all other
9 correspondence by a dental laboratory to the prescribing dentist.
10 4. A dental laboratory registration shall require renewal on a trien-
11 nial basis from the date of issuance. Registrations may be renewed with
12 the department upon receipt and approval of application materials as
13 required by subdivision two of this section.
14 5. (a) This section shall not apply to a dental laboratory operating
15 under the supervision of a practicing dentist licensed under article one
16 hundred thirty-three of the education law in a dental office or as a
17 part of a dental practice, provided that the laboratory does not perform
18 work for a prescribing dentist from outside of the supervising dentist's
19 dental practice or supervising dentist's office, or in an educational
20 institution as part of the institution's educational program, provided
21 that the dental laboratory does not routinely perform work for prescrib-
22 ing dentists from outside of the educational institution.
23 (b) A responsible person or employee of a dental laboratory may engage
24 in onsite consultation with a licensed dentist during a dental proce-
25 dure.
26 § 592. Nonresident dental laboratories. 1. The term "nonresident
27 dental laboratory" shall mean any dental laboratory as defined in subdi-
28 vision three of section five hundred ninety of this title that is
29 located outside of this state which has its work product prepared pursu-
30 ant to a prescription or any other written or electronic instrument from
31 a licensed dentist or work authorization originating from an entity
32 located within this state.
33 2. Any nonresident dental laboratory that ships, mails, or delivers
34 dental prostheses, devices or appliances to any other dental laboratory,
35 dental office, licensed dentist, and/or patient in this state pursuant
36 to a prescription or any other written or electronic instrument from a
37 licensed dentist or work authorization originating from an entity
38 located within this state shall be registered with the department.
39 3. Each nonresident dental laboratory that ships, mails, or delivers
40 dental prostheses, devices or appliances into this state shall designate
41 a resident agent in this state for service of process pursuant to rule
42 three hundred eighteen of the civil practice law and rules.
43 4. As a condition of registration, a nonresident dental laboratory
44 shall comply with the following requirements:
45 (a) Be in good standing in the state of residence;
46 (b) Maintain, in readily retrievable form, records of work product
47 shipped into this state;
48 (c) Supply, upon request, all information needed by the department to
49 carry out the department's responsibilities under the laws and rules and
50 regulations pertaining to nonresident dental laboratories;
51 (d) Comply with all statutory and regulatory requirements of the state
52 where the nonresident dental laboratory is located;
53 (e) Apply in the manner and form prescribed by the department pursuant
54 to the requirements of subdivision two of section five hundred ninety-
55 one of this title.
A. 1364--A 5
1 5. The department may adopt such regulations as appropriate to evalu-
2 ate registrations from dental laboratories that hold valid licenses,
3 registrations, certifications or their equivalent in another state or
4 country, provided the standards for granting licenses, registrations, or
5 certifications to such facilities are not less than the standards
6 required of dental laboratories otherwise registered pursuant to this
7 title.
8 § 593. Enforcement and penalties. 1. A registration issued pursuant to
9 this title may be revoked or suspended by the department on proof that
10 the responsible person or one or more persons in their employ:
11 (a) has been guilty of misrepresentation in obtaining the registration
12 or in the operation of the dental laboratory;
13 (b) has shipped, mailed, or delivered dental prostheses, devices or
14 appliances into this state performed in another dental laboratory with-
15 out designating the fact that such work product was performed by another
16 dental laboratory;
17 (c) has failed to renew any registration required by the provisions of
18 this title; or
19 (d) has not otherwise complied with the requirements of this title.
20 2. Any person or entity which owns or operates a dental laboratory and
21 does not hold a valid registration shall be liable for a civil penalty
22 not to exceed one thousand dollars for each day for the unregistered
23 operation of such laboratory.
24 3. Any violation of any other provision of this title shall be subject
25 to a fine of not more than one thousand dollars. A second or subsequent
26 violation shall be punishable by a fine of not more than two thousand
27 five hundred dollars.
28 § 4. This act shall take effect one year after it shall have become a
29 law. Effective immediately, the addition, amendment and/or repeal of any
30 rule or regulation necessary for the implementation of this act on its
31 effective date are authorized to be made and completed on or before such
32 effective date.
