The following data is part of a premarket notification filed by Pressing Di Monticelli Rag. Stefano with the FDA for Acetal Dental/preformed Clasp.
| Device ID | K955946 |
| 510k Number | K955946 |
| Device Name: | ACETAL DENTAL/PREFORMED CLASP |
| Classification | Clasp, Preformed |
| Applicant | PRESSING DI MONTICELLI RAG. STEFANO 233 VIA EMILIA ROMAGNA Cattilica, IT 47033 |
| Contact | Stefano Monticelli |
| Correspondent | Stefano Monticelli PRESSING DI MONTICELLI RAG. STEFANO 233 VIA EMILIA ROMAGNA Cattilica, IT 47033 |
| Product Code | EHP |
| CFR Regulation Number | 872.3285 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-27 |
| Decision Date | 1995-12-11 |