The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Nc Straumann Variobase Abutment For Bars/bridges, Rc Straumann Variobase Abutment For Bars/bridges, Nnc Straumann Variobase Abutment For Bars/bridges, Rn Straumann Variobase Abutment For Bars/bridges, Wn Straumann Variobase Abutment For Bars/bridges.
| Device ID | K151157 |
| 510k Number | K151157 |
| Device Name: | NC Straumann Variobase Abutment For Bars/Bridges, RC Straumann Variobase Abutment For Bars/Bridges, NNC Straumann Variobase Abutment For Bars/Bridges, RN Straumann Variobase Abutment For Bars/Bridges, WN Straumann Variobase Abutment For Bars/Bridges |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Christopher Klaczyk |
| Correspondent | Christopher Klaczyk STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-01 |
| Decision Date | 2015-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031707628 | K151157 | 000 |
| 07630031704252 | K151157 | 000 |
| 07630031704269 | K151157 | 000 |
| 07630031704276 | K151157 | 000 |
| 07630031704283 | K151157 | 000 |
| 07630031707581 | K151157 | 000 |
| 07630031707598 | K151157 | 000 |
| 07630031707604 | K151157 | 000 |
| 07630031707611 | K151157 | 000 |
| 07630031704245 | K151157 | 000 |