The following data is part of a premarket notification filed by Ivoclar Usa, Inc. with the FDA for Sr Vivodent Pe Anterior Teeth & Sr Orthotyp Re Pos.
| Device ID | K844349 |
| 510k Number | K844349 |
| Device Name: | SR VIVODENT PE ANTERIOR TEETH & SR ORTHOTYP RE POS |
| Classification | Denture, Plastic, Teeth |
| Applicant | IVOCLAR USA, INC. BAUER, CHENG & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer IVOCLAR USA, INC. BAUER, CHENG & ASSOCIATES 111 N. WABASH Chicago, IL 60602 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-11-09 |
| Decision Date | 1984-12-03 |