The following data is part of a premarket notification filed by Straumann Usa with the FDA for Straumann Prefgel.
| Device ID | K063812 |
| 510k Number | K063812 |
| Device Name: | STRAUMANN PREFGEL |
| Classification | Cleanser, Root Canal |
| Applicant | STRAUMANN USA 60 MINUTETEMAN ROAD Andover, MA 01810 |
| Contact | Lisa M Quaglia |
| Correspondent | Lisa M Quaglia STRAUMANN USA 60 MINUTETEMAN ROAD Andover, MA 01810 |
| Product Code | KJJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2007-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031730053 | K063812 | 000 |