The following data is part of a premarket notification filed by Straumann Usa with the FDA for Tl 04.1mm Rn,s, Slactive Tizr 6, 8, 10, 12, 14, 16mm Dental Implants.
| Device ID | K122855 |
| 510k Number | K122855 |
| Device Name: | TL 04.1MM RN,S, SLACTIVE TIZR 6, 8, 10, 12, 14, 16MM DENTAL IMPLANTS |
| 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 | 2012-09-18 |
| Decision Date | 2012-12-12 |
| Summary: | summary |