The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Dental Implant System.
| Device ID | K130222 |
| 510k Number | K130222 |
| Device Name: | STRAUMANN DENTAL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Jennifer M Jackson, Ms |
| Correspondent | Jennifer M Jackson, Ms STRAUMANN USA, LLC 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 | 2013-01-29 |
| Decision Date | 2013-04-29 |
| Summary: | summary |