The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for P.004 Nc Cares Titanium And Ceramic Abutments.
| Device ID | K081005 |
| 510k Number | K081005 |
| Device Name: | P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-08 |
| Decision Date | 2008-05-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031713544 | K081005 | 000 |
| 07630031713537 | K081005 | 000 |
| 07630031711816 | K081005 | 000 |