The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Variobase For Cerec.
| Device ID | K151324 |
| 510k Number | K151324 |
| Device Name: | Straumann Variobase For CEREC |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Christopher Klaczyk |
| Correspondent | Sheila Hemeon-heyer Heyer Regulatory Solutions LLC 125 Cherry Lane Amherst, MA 01002 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-18 |
| Decision Date | 2015-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031707833 | K151324 | 000 |
| 07630031707789 | K151324 | 000 |
| 07630031707772 | K151324 | 000 |
| 07630031707734 | K151324 | 000 |
| 07630031707727 | K151324 | 000 |