The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Dental Implant System.
| Device ID | K081419 |
| 510k Number | K081419 |
| Device Name: | STRAUMANN DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INSTITUT STRAUMANN AG 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Lisa Quaglia |
| Correspondent | Lisa Quaglia INSTITUT STRAUMANN AG 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 | 2008-05-20 |
| Decision Date | 2009-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031716507 | K081419 | 000 |
| 07630031716491 | K081419 | 000 |
| 07630031716484 | K081419 | 000 |
| 07630031716477 | K081419 | 000 |