KOO · Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
Dental · 21 CFR 872.3490 · Class 1
Overview
| Product Code | KOO |
|---|---|
| Device Name | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt |
| Regulation | 21 CFR 872.3490 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive is a device composed of carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt 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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K945200 | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES | Procter & Gamble Co. | Nov 30, 1994 | SESE |
| K943486 | ORAFIX SPECIAL DENTURE ADHESIVE | Smithkline Beecham Corp. | Nov 3, 1994 | SESE |
| K930335 | PROFAST - DENTURE ADHESIVE FOR LOWER JAWS | Fittydent-Altwirth & Schmitt GmbH | Feb 1, 1994 | SESE |
| K862876 | NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Block Drug Company, Inc. | Aug 29, 1986 | SESE |
Top Applicants
- Block Drug Company, Inc. — 1 clearance
- Fittydent-Altwirth & Schmitt GmbH — 1 clearance
- Procter & Gamble Co. — 1 clearance
- Smithkline Beecham Corp. — 1 clearance
