RELATES TO:
KRS 313.021,
313.022,
313.550
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 and the 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 Kentucky
shall register with the board.
(2)
A dental laboratory shall be considered operating or doing business in Kentucky
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. 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
5. 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 6. Initial Registration.
(1) The owner or operator of a commercial
dental laboratory desiring to obtain a registration shall:
(a) Submit an Application for Registration of
Dental Laboratories; and
(2) The application shall include:
(a) The name, mailing address, phone number,
and e-mail address of the laboratory;
(b) The physical address of the laboratory if
different from the mailing address;
(c) 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; and
(d)
An acknowledgement by the supervising CDT or dentist who is licensed in this
state that the laboratory:
1. 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;
2. 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
3. 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 7. Registration Renewal.
(1) Commercial dental laboratory
registrations shall expire on July 31 of each year and shall be renewed to
continue operating or doing business in Kentucky.
(2) To renew a registration, the owner or
operator shall:
(a) Submit a Renewal
Application for Registration of Dental Laboratories on or before July 31;
and
(3) The renewal application shall
include the information required in Section 6(2)(a)-(d) of this administrative
regulation.
Section 8.
Incorporation by Reference.
(1) The following
material is incorporated by reference:
(a)
"Application for Registration of Dental Laboratories", November 2022;
and
(b) "Renewal Application for
Registration of Dental Laboratories", November 2022.
(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.
