The following data is part of a premarket notification filed by Nobelpharma Usa, Inc. with the FDA for Denture Plastic Teeth,76 Elm.
| Device ID | K915276 |
| 510k Number | K915276 |
| Device Name: | DENTURE PLASTIC TEETH,76 ELM |
| Classification | Denture, Plastic, Teeth |
| Applicant | NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Ronald Dudek |
| Correspondent | Ronald Dudek NOBELPHARMA USA, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-25 |
| Decision Date | 1992-02-03 |