The following data is part of a premarket notification filed by Straumann Usa with the FDA for Straumann Tibrush.
| Device ID | K111724 |
| 510k Number | K111724 |
| Device Name: | STRAUMANN TIBRUSH |
| Classification | Scaler, Rotary |
| Applicant | STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Elaine Alan |
| Correspondent | Elaine Alan STRAUMANN USA 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | ELB |
| CFR Regulation Number | 872.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-20 |
| Decision Date | 2011-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031726780 | K111724 | 000 |