The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Variobase C.
| Device ID | K192742 |
| 510k Number | K192742 |
| Device Name: | Straumann Variobase C |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Lochhamer Schlag 6 Grafelfing, DE 82166 |
| Contact | Gordon Dodds |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01801 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2021-02-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031747068 | K192742 | 000 |
| 07630031771469 | K192742 | 000 |
| 07630031771476 | K192742 | 000 |
| 07630031771438 | K192742 | 000 |
| 07630031771445 | K192742 | 000 |
| 07630031707710 | K192742 | 000 |
| 07630031707819 | K192742 | 000 |
| 07630031707826 | K192742 | 000 |
| 07630031747044 | K192742 | 000 |
| 07630031747051 | K192742 | 000 |
| 07630031771452 | K192742 | 000 |