The following data is part of a premarket notification filed by Pemaco, Inc. with the FDA for Intraoral Dental Wax.
| Device ID | K910676 |
| 510k Number | K910676 |
| Device Name: | INTRAORAL DENTAL WAX |
| Classification | Wax, Dental, Intraoral |
| Applicant | PEMACO, INC. 1345 WEST LARK INDUSTRIAL PARK Fenton, MO 63026 |
| Contact | Richard L Perkowski |
| Correspondent | Richard L Perkowski PEMACO, INC. 1345 WEST LARK INDUSTRIAL PARK Fenton, MO 63026 |
| Product Code | EGD |
| CFR Regulation Number | 872.6890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-15 |
| Decision Date | 1991-08-21 |