The following data is part of a premarket notification filed by Straumann Manufacturing, Inc. with the FDA for Straumann Dental Abutments.
| Device ID | K092814 |
| 510k Number | K092814 |
| Device Name: | STRAUMANN DENTAL ABUTMENTS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan STRAUMANN MANUFACTURING, INC. 60 MINUTEMAN RD. Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-14 |
| Decision Date | 2009-12-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031710468 | K092814 | 000 |
| 07630031710444 | K092814 | 000 |