The following data is part of a premarket notification filed by Straumann Usa with the FDA for Bl, 04.1 Mm Rc, Slactive 8mm, Tizr And 10mm, 12, 14mm.
| Device ID | K121131 |
| 510k Number | K121131 |
| Device Name: | BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-13 |
| Decision Date | 2012-06-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031707307 | K121131 | 000 |
| 07630031706843 | K121131 | 000 |
| 07630031706850 | K121131 | 000 |
| 07630031706867 | K121131 | 000 |
| 07630031706874 | K121131 | 000 |
| 07630031706881 | K121131 | 000 |
| 07630031706898 | K121131 | 000 |
| 07630031707246 | K121131 | 000 |
| 07630031707253 | K121131 | 000 |
| 07630031707260 | K121131 | 000 |
| 07630031707277 | K121131 | 000 |
| 07630031707284 | K121131 | 000 |
| 07630031707291 | K121131 | 000 |
| 07630031706836 | K121131 | 000 |