The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Immediate Temporary Abutments.
| Device ID | K201681 |
| 510k Number | K201681 |
| Device Name: | Straumann Immediate Temporary Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Peter Merian-Weg 12 Basel, CH Ch-4002 |
| Contact | Viviana Horhoiu |
| Correspondent | Chanrasmey White 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 | 2020-06-22 |
| Decision Date | 2021-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031755780 | K201681 | 000 |
| 07630031753168 | K201681 | 000 |
| 07630031753175 | K201681 | 000 |
| 07630031753182 | K201681 | 000 |
| 07630031753199 | K201681 | 000 |
| 07630031753205 | K201681 | 000 |
| 07630031753212 | K201681 | 000 |
| 07630031753229 | K201681 | 000 |
| 07630031753236 | K201681 | 000 |
| 07630031753243 | K201681 | 000 |
| 07630031753250 | K201681 | 000 |
| 07630031753267 | K201681 | 000 |
| 07630031753151 | K201681 | 000 |