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
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
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.)