The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann(r) Variobase(tm) Abutment Nnc, Straumann(r) Variobase(tm) Abutment Rn, Straumann(r) Variobase(tm) Abutment Wn,.
| Device ID | K132219 |
| 510k Number | K132219 |
| Device Name: | STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN, |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Jennifer M Jackson |
| Correspondent | Jennifer M Jackson 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 | 2013-07-17 |
| Decision Date | 2014-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031727954 | K132219 | 000 |
| 07630031711885 | K132219 | 000 |
| 07630031712677 | K132219 | 000 |
| 07630031725929 | K132219 | 000 |
| 07630031725936 | K132219 | 000 |
| 07630031725943 | K132219 | 000 |
| 07630031725950 | K132219 | 000 |
| 07630031725967 | K132219 | 000 |
| 07630031707741 | K132219 | 000 |
| 07630031707758 | K132219 | 000 |
| 07630031707765 | K132219 | 000 |
| 07630031707796 | K132219 | 000 |
| 07630031707802 | K132219 | 000 |
| 07630031727824 | K132219 | 000 |
| 07630031727831 | K132219 | 000 |
| 07630031727930 | K132219 | 000 |
| 07630031727947 | K132219 | 000 |
| 07630031710949 | K132219 | 000 |