The following data is part of a premarket notification filed by Straumann Manufacturing, Inc. with the FDA for Modification To:straumann Guided Instruments.
| Device ID | K090260 |
| 510k Number | K090260 |
| Device Name: | MODIFICATION TO:STRAUMANN GUIDED INSTRUMENTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-03 |
| Decision Date | 2009-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031716552 | K090260 | 000 |
| 07630031714688 | K090260 | 000 |
| 07630031714664 | K090260 | 000 |
| 07630031714558 | K090260 | 000 |
| 07630031714534 | K090260 | 000 |
| 07630031714510 | K090260 | 000 |
| 07630031707222 | K090260 | 000 |
| 07630031707208 | K090260 | 000 |
| 07630031707185 | K090260 | 000 |
| 07630031706812 | K090260 | 000 |
| 07630031706799 | K090260 | 000 |
| 07630031714701 | K090260 | 000 |
| 07630031714916 | K090260 | 000 |
| 07630031716538 | K090260 | 000 |
| 07630031716514 | K090260 | 000 |
| 07630031715678 | K090260 | 000 |
| 07630031715654 | K090260 | 000 |
| 07630031715630 | K090260 | 000 |
| 07630031715593 | K090260 | 000 |
| 07630031715579 | K090260 | 000 |
| 07630031715555 | K090260 | 000 |
| 07630031714954 | K090260 | 000 |
| 07630031714930 | K090260 | 000 |
| 07630031706775 | K090260 | 000 |