The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Cares Variobase Abutment Nnc, Straumann Cares Variobase Abutment Rn, Straumann Cares Variobase Abutment Wn, St.
| Device ID | K120822 |
| 510k Number | K120822 |
| Device Name: | STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | INSTITUT STRAUMANN AG PETER-MERIAN-WEG 12 Basel, CH Ch-4052 |
| Contact | Andreas Petermann |
| Correspondent | Andreas Petermann INSTITUT STRAUMANN AG PETER-MERIAN-WEG 12 Basel, CH Ch-4052 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031725912 | K120822 | 000 |
| 07630031708892 | K120822 | 000 |
| 07630031725974 | K120822 | 000 |
| 07630031708106 | K120822 | 000 |
| 07630031708113 | K120822 | 000 |
| 07630031708878 | K120822 | 000 |
| 07630031708885 | K120822 | 000 |
| 07630031725868 | K120822 | 000 |
| 07630031725875 | K120822 | 000 |
| 07630031725882 | K120822 | 000 |
| 07630031725899 | K120822 | 000 |
| 07630031725905 | K120822 | 000 |
| 07630031708120 | K120822 | 000 |