[Federal Register Volume 67, Number 130 (Monday, July 8, 2002)]
[Notices]
[Pages 45129-45130]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-17079]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0274]


Denture Cleaners, Adhesives, Cushions, and Repair Materials; 
Revocation of Compliance Policy Guide 7124.05

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is revoking the 
Compliance Policy Guide (CPG) entitled ``Sec. 315.200 Status of Dental 
Supplies such as Denture Cleaners, Adhesives, Cushions, and Repair 
Materials as a Device or Cosmetic (CPG 7124.05).'' This CPG is no 
longer necessary because the agency has classified these products as 
devices.

DATES: The revocation is effective August 7, 2002.

ADDRESSES: Submit written requests for single copies of the CPG to the 
Division of Compliance Policy (HFC-230), Office of Enforcement, Office 
of Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857 (301-827-0411) or fax your request to 301-827-0482.
    A copy of the CPG may be seen in the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Jeffrey B. Governale, Division of 
Compliance Policy (HFC-230), Office of Enforcement, Office of 
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-0411.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issued the CPG entitled ``Sec. 315.200 Status of Dental 
Supplies such

[[Page 45130]]

as Denture Cleaners, Adhesives, Cushions, and Repair Materials as a 
Device or Cosmetic (CPG 7124.05)'' on April 26, 1976. This CPG, as 
revised on August 9, 1988, considered these products to be devices 
within the meaning of section 201(h) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 321(h)).
    In accordance with section 513 of the act (21 U.S.C. 360c), the 
agency has classified dental products as devices by regulation, 
including but not limited to:
    1. Karaya and sodium borate with or without acacia denture adhesive 
(21 CFR 872.3400)
    2. Ethylene oxide homopolymer and/or carboxymethylcellulose sodium 
denture adhesive (21 CFR 872.3410)
    3. Carboxymethylcellulose sodium and cationic polyacrylamide 
polymer denture adhesive (21 CFR 872.3420)
    4. Ethylene oxide homopolymer and/or karaya denture adhesive (21 
CFR 872.3450)
    5. Polyacrylamide polymer (modified cationic) denture adhesive (21 
CFR 872.3480)
    6. Carboxymethylcellulose sodium and/or polyvinylmethylether maleic 
acid calcium-sodium double salt denture adhesive (21 CFR 872.3490)
    7. Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, 
and carboxymethylcellulose sodium (NACMC) denture adhesive (21 CFR 
872.3500)
    8. Over-the-counter (OTC) denture cleanser (21 CFR 872.3520)
    9. Mechanical denture cleaner (21 CFR 872.3530)
    10. OTC denture cushion or pad (21 CFR 872.3540)
    11. OTC denture repair kit (21 CFR 872.3570)
    12. Denture relining, repairing, or rebasing resin (21 CFR 
872.3760)
    Given these device classifications, FDA is revoking CPG 7124.05, in 
its entirety, to eliminate unnecessary compliance policy.

II. Electronic Access

    Prior to August 7, 2002, a copy of the CPG may also be downloaded 
to a personal computer with access to the Internet. The Office of 
Regulatory Affairs (ORA) home page includes the referenced document 
that may be accessed at http://www.fda.gov/ora/compliance_ref/cpg/cpgdev/cpg315-200.html.

    Dated: June 28, 2002.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 02-17079 Filed 7-5-02; 8:45 am]
BILLING CODE 4160-01-S