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Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

Page Type
Product Code
Definition
Call for PMAs 12/26/96 per 61 FR 50707 on 9/27/96
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
PMA
Device Classification
Class 3
Regulation Number
872.3500
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive

§ 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.

(a) Identification. Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive is a device composed of polyvinylmethylether maleic anhydride, acid copolymer, and carboxymethylcellulose sodium intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive that was in commercial distribution before May 28, 1976. Any other polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]

Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

Page Type
Product Code
Definition
Call for PMAs 12/26/96 per 61 FR 50707 on 9/27/96
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
PMA
Device Classification
Class 3
Regulation Number
872.3500
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive

§ 872.3500 Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive.

(a) Identification. Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive is a device composed of polyvinylmethylether maleic anhydride, acid copolymer, and carboxymethylcellulose sodium intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive that was in commercial distribution before May 28, 1976. Any other polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]