The following data is part of a premarket notification filed by Straumann Usa with the FDA for Straumann Narrow Neck Crossfit (nnc) 03.3mm Dental Implant System.
| Device ID | K111357 |
| 510k Number | K111357 |
| Device Name: | STRAUMANN NARROW NECK CROSSFIT (NNC) 03.3MM DENTAL IMPLANT SYSTEM |
| 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 | 2011-05-16 |
| Decision Date | 2011-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031725158 | K111357 | 000 |
| 07630031715524 | K111357 | 000 |
| 07630031715531 | K111357 | 000 |
| 07630031715548 | K111357 | 000 |
| 07630031722607 | K111357 | 000 |
| 07630031722652 | K111357 | 000 |
| 07630031722720 | K111357 | 000 |
| 07630031724137 | K111357 | 000 |
| 07630031724175 | K111357 | 000 |
| 07630031724793 | K111357 | 000 |
| 07630031724809 | K111357 | 000 |
| 07630031715517 | K111357 | 000 |