The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Ceramic Healing Abutments.
| Device ID | K192893 |
| 510k Number | K192893 |
| Device Name: | Straumann Ceramic Healing Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH Ch-4002 |
| Contact | Laure Kuhner Borsenberger |
| 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 | 2019-10-11 |
| Decision Date | 2020-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031745989 | K192893 | 000 |
| 07630031745279 | K192893 | 000 |
| 07630031745286 | K192893 | 000 |
| 07630031745293 | K192893 | 000 |
| 07630031745309 | K192893 | 000 |
| 07630031745316 | K192893 | 000 |
| 07630031745859 | K192893 | 000 |
| 07630031745866 | K192893 | 000 |
| 07630031745873 | K192893 | 000 |
| 07630031745880 | K192893 | 000 |
| 07630031745897 | K192893 | 000 |
| 07630031745903 | K192893 | 000 |
| 07630031745934 | K192893 | 000 |
| 07630031745941 | K192893 | 000 |
| 07630031745958 | K192893 | 000 |
| 07630031745965 | K192893 | 000 |
| 07630031745972 | K192893 | 000 |
| 07630031745262 | K192893 | 000 |