The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Bone Level Tapered Implants.
| Device ID | K153758 |
| 510k Number | K153758 |
| Device Name: | Straumann Bone Level Tapered Implants |
| Classification | Implant, Endosseous, Root-form |
| Applicant | INSTITUT STRAUMANN AG PETER MERIAN-WEG 12 Basel, CH Ch-4002 |
| Contact | Christopher Klaczyk |
| Correspondent | Jennifer Jackson STRAUMANN USA, INC. 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 | 2015-12-30 |
| Decision Date | 2016-03-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031729927 | K153758 | 000 |
| 07630031729903 | K153758 | 000 |
| 07630031729897 | K153758 | 000 |
| 07630031729873 | K153758 | 000 |
| 07630031729866 | K153758 | 000 |
| 07630031729842 | K153758 | 000 |