The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Blx Ø3.5 Mm Implants.
| Device ID | K191256 |
| 510k Number | K191256 |
| Device Name: | Straumann BLX Ø3.5 Mm Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH Ch-4002 |
| Contact | Ana C. M. Vianna |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01801 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-10 |
| Decision Date | 2019-12-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031743398 | K191256 | 000 |
| 07630031743282 | K191256 | 000 |
| 07630031743299 | K191256 | 000 |
| 07630031743305 | K191256 | 000 |
| 07630031743312 | K191256 | 000 |
| 07630031743329 | K191256 | 000 |
| 07630031743343 | K191256 | 000 |
| 07630031743350 | K191256 | 000 |
| 07630031743367 | K191256 | 000 |
| 07630031743374 | K191256 | 000 |
| 07630031743381 | K191256 | 000 |
| 07630031743275 | K191256 | 000 |