The following data is part of a premarket notification filed by Straumann Usa with the FDA for Straumann Guided Instruments.
| Device ID | K082532 |
| 510k Number | K082532 |
| Device Name: | STRAUMANN GUIDED INSTRUMENTS |
| Classification | Drill, Bone, Powered |
| 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 | DZI |
| CFR Regulation Number | 872.4120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2008-10-21 |
| Summary: | summary |