The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Tlx Sras And Tlx Gold Abutments.
| Device ID | K213063 |
| 510k Number | K213063 |
| Device Name: | TLX SRAs And TLX Gold Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH Ch-4002 |
| Contact | Gina Chang |
| 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 | 2021-09-23 |
| Decision Date | 2022-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031755209 | K213063 | 000 |
| 07630031755193 | K213063 | 000 |
| 07630031755186 | K213063 | 000 |
| 07630031755179 | K213063 | 000 |
| 07630031755162 | K213063 | 000 |
| 07630031755155 | K213063 | 000 |
| 07630031755148 | K213063 | 000 |
| 07630031755131 | K213063 | 000 |