201

KAR 8:016. Registration of dental laboratories.

 

      RELATES TO: KRS 313.021, 313.022, 313.550

      STATUTORY AUTHORITY: KRS 313.021(1)(a), (c),

313.022(1)(c), 313.080, 313.090, 313.100

      NECESSITY, FUNCTION, AND CONFORMITY: KRS

313.021(1)(a) requires the board to govern dental laboratories. KRS 313.021(1)(c)

requires the board to promulgate administrative regulations for any license or

registration created by the board. KRS 313.022(1) requires the board to

promulgate administrative regulations to prescribe a reasonable schedule of

fees, charges, and fines. This administrative regulation establishes

requirements for the issuance and renewal of dental laboratory registration

with the board. This administrative regulation establishes fees for the

issuance, renewal, and reinstatement of registrations of dental laboratories

with the board.

 

      Section 1. (1) Each commercial dental

laboratory operating, doing business, or intending to operate or do business in

the state shall register with the board and pay the fee established in Sections

4 and 8 of this administrative regulation.

      (2) A dental laboratory shall be

considered operating or doing business within this state if its work product is

prepared pursuant to a written authorization originating within this state.

 

      Section 2. The board shall not issue a registration

to a commercial dental laboratory unless the applying dental laboratory is operated

under the supervision of at least one (1) certified dental technician (CDT) or

dentist licensed in this state in accordance with KRS 313.550.

 

      Section 3. If the dental laboratory has

violated any provision of KRS Chapter 313 or 201 KAR Chapter 8, the dental

laboratory shall be subject to disciplinary action pursuant to KRS 313.080 and

313.100.

 

      Section 4. Each commercial dental

laboratory shall pay a fee of $150 to the board before a registration shall be

issued to the applicant.

 

      Section 5. Upon the granting of a registration,

the board shall assign to that laboratory a dental registration number. The

laboratory registration number shall appear on all invoices or other correspondence

of the laboratory.

 

      Section 6. A dentist shall use only those

services of a commercial dental laboratory that is duly registered with the

board as required by this administrative regulation. A dentist shall include the

registration number of the dental laboratory on the dentist’s work order.

 

      Section 7. Each commercial dental

laboratory operating, doing business, or intending to operate or do business

within the state shall submit an Application for Registration of Dental

Laboratory or Renewal of Registration of Dental Laboratory to the board on a

form provided by the board accompanied with the registration or renewal fee

required. The application shall include:

      (1) The name, mailing address, phone

number, and e-mail address of the laboratory;

      (2) The physical address of the

laboratory if different from the mailing address;

      (3) The name and CDT number of the

supervising CDT or the name and license number of the supervising dentist who

is licensed in this state;

      (4) A statement that the laboratory meets

the infectious disease control requirements under Occupational Safety and

Health Administration (OSHA) and the Centers for Disease Control and Prevention

(CDC) of the United States Public Health Service;

      (5) An acknowledgement by the supervising

CDT or dentist who is licensed in this state that the laboratory will provide

material disclosure to the prescribing dentist that contains the U.S. Food and

Drug Administration registration number of all patient contact materials

contained in the prescribed restoration in order that the dentist may include those

numbers in the patient's record; and

      (6) An acknowledgement by the supervising

CDT or dentist who is licensed in this state that he or she will disclose to the

prescribing dentist the point of origin of the manufacture of the prescribed

restoration. If the restoration was partially or entirely manufactured by a

third-party provider, the point of origin disclosure shall identify the portion

manufactured by a third-party provider and the city, state, and country of the

provider.

 

      Section 8. Each commercial dental

laboratory registered with the board shall be required to renew its

registration before July 31 each year by completing and submitting a Renewal of

Registration of Dental Laboratory form and paying a fee of $150.

 

      Section 9. Incorporation by Reference. (1)

The following material is incorporated by reference:

      (a) "Application for Registration of

Dental Laboratories”, June 2014; and

      (b) "Renewal Application for

Registration of Dental Laboratories”, March 2014.

      (2) This material may be inspected,

copied, or obtained, subject to applicable copyright law, at the Kentucky Board

of Dentistry, 312 Whittington Parkway, Suite 101, Louisville, Kentucky 40222,

Monday through Friday, 8 a.m. through 4:30 p.m. This material is also available

on the board’s Web site at http://dentistry.ky.gov. (40 Ky.R. 2385; Am.

2679; 41 Ky.R. 257; eff. 6-18-2014.)