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 |