The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Fixafloss.
| Device ID | K071615 |
| 510k Number | K071615 |
| Device Name: | FIXAFLOSS |
| Classification | Clamp, Rubber Dam |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867 |
| Contact | Colleen Boswell |
| Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 W. COLLINS AVE. Orange, CA 92867 |
| Product Code | EEF |
| CFR Regulation Number | 872.6300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-13 |
| Decision Date | 2007-09-21 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FIXAFLOSS 79049298 3468382 Dead/Cancelled |
KerrHawe S.A. 2007-11-23 |