The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Orthosystem.
| Device ID | K060062 |
| 510k Number | K060062 |
| Device Name: | STRAUMANN ORTHOSYSTEM |
| Classification | Implant, Endosseous, Orthodontic |
| Applicant | INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | OAT |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-09 |
| Decision Date | 2006-02-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031722713 | K060062 | 000 |
| 07630031722706 | K060062 | 000 |
| 07630031722690 | K060062 | 000 |
| 07630031722683 | K060062 | 000 |
| 07630031722676 | K060062 | 000 |
| 07630031718174 | K060062 | 000 |
| 07630031718167 | K060062 | 000 |