The following data is part of a premarket notification filed by Straumann Usa with the FDA for P.004 Rc Cares Titanium And Ceramic Abutments.
| Device ID | K072151 |
| 510k Number | K072151 |
| Device Name: | P.004 RC CARES TITANIUM AND CERAMIC ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA 60 MINUTETEMAN ROAD Andover, MA 01810 |
| Contact | Paige Sweeney |
| Correspondent | Paige Sweeney 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 | 2007-08-03 |
| Decision Date | 2007-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031713773 | K072151 | 000 |
| 07630031713766 | K072151 | 000 |
| 07630031712608 | K072151 | 000 |