The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Blx Wb Ø5.0 (l18), Ø5.5 And Ø6.5 Mm (l14 And L16) Implants.
| Device ID | K212533 |
| 510k Number | K212533 |
| Device Name: | BLX WB Ø5.0 (L18), Ø5.5 And Ø6.5 Mm (L14 And L16) Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH Ch-4002 |
| Contact | Corinne Arimatea |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-11 |
| Decision Date | 2022-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031755438 | K212533 | 000 |
| 07630031755421 | K212533 | 000 |
| 07630031755414 | K212533 | 000 |
| 07630031755407 | K212533 | 000 |
| 07630031755391 | K212533 | 000 |
| 07630031755384 | K212533 | 000 |
| 07630031755377 | K212533 | 000 |
| 07630031755360 | K212533 | 000 |
| 07630031743848 | K212533 | 000 |