The following data is part of a premarket notification filed by Smithkline Beecham Corp. with the FDA for Orafix Special Denture Adhesive.
| Device ID | K943486 |
| 510k Number | K943486 |
| Device Name: | ORAFIX SPECIAL DENTURE ADHESIVE |
| Classification | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt |
| Applicant | SMITHKLINE BEECHAM CORP. 1500 LITTLETON RD. Parsippany, NJ 07054 -3884 |
| Contact | Anthony G Amitrano |
| Correspondent | Anthony G Amitrano SMITHKLINE BEECHAM CORP. 1500 LITTLETON RD. Parsippany, NJ 07054 -3884 |
| Product Code | KOO |
| CFR Regulation Number | 872.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-19 |
| Decision Date | 1994-11-03 |