The following data is part of a premarket notification filed by Straumann Usa, Llc (on Behalf Of Institut Straumann Ag) with the FDA for Straumann Blx Gold Abutments.
| Device ID | K200597 |
| 510k Number | K200597 |
| Device Name: | Straumann BLX Gold Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Straumann USA, LLC (On Behalf Of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 |
| Contact | Chanrasmey White |
| Correspondent | Chanrasmey White Straumann USA, LLC (On Behalf Of Institut Straumann AG) 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 | 2020-03-09 |
| Decision Date | 2020-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031747105 | K200597 | 000 |
| 07630031747099 | K200597 | 000 |
| 07630031747082 | K200597 | 000 |
| 07630031747075 | K200597 | 000 |