The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Nc Temporary Abutment, Cad-temp, Pmma Rc Temporary Abutment, Cad-temp, Pmma Rn Temporary Abutment, Cad-temp, Pmma Wn Tem.
| Device ID | K122192 |
| 510k Number | K122192 |
| Device Name: | NC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RC TEMPORARY ABUTMENT, CAD-TEMP, PMMA RN TEMPORARY ABUTMENT, CAD-TEMP, PMMA WN TEM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan 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 | 2012-07-24 |
| Decision Date | 2012-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031725820 | K122192 | 000 |
| 07630031725639 | K122192 | 000 |
| 07630031723758 | K122192 | 000 |
| 07630031710901 | K122192 | 000 |
| 07630031710451 | K122192 | 000 |