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 |