The following data is part of a premarket notification filed by Straumann Usa with the FDA for Straumann Computer Aided Restoration Service (c.a.r.e.s.) Ceramic Coping.
| Device ID | K061277 |
| 510k Number | K061277 |
| Device Name: | STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA 60 MINUTETEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan STRAUMANN USA 60 MINUTETEMAN ROAD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-08 |
| Decision Date | 2007-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031728937 | K061277 | 000 |
| 07630031728906 | K061277 | 000 |
| 07630031728852 | K061277 | 000 |
| 07630031724229 | K061277 | 000 |
| 07630031717733 | K061277 | 000 |
| 07630031717757 | K061277 | 000 |