The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Blx Temporary Abutment, Vita Cad-temp, Pmma.
| Device ID | K220751 |
| 510k Number | K220751 |
| Device Name: | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH CH-4002 |
| Contact | Viviana Horhoiu |
| 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 | 2022-03-15 |
| Decision Date | 2022-06-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031759276 | K220751 | 000 |
| 07630031759269 | K220751 | 000 |
| 07630031759252 | K220751 | 000 |