The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Pureloc Abutments.
| Device ID | K192029 |
| 510k Number | K192029 |
| Device Name: | Straumann PUREloc Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH Ch-4002 |
| Contact | Giulia Oran |
| 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 | 2019-07-30 |
| Decision Date | 2019-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031735768 | K192029 | 000 |
| 07630031735751 | K192029 | 000 |
| 07630031735744 | K192029 | 000 |
| 07630031735737 | K192029 | 000 |
| 07630031735720 | K192029 | 000 |
| 07630031735713 | K192029 | 000 |