The following data is part of a premarket notification filed by Kerr Dental Materials Center with the FDA for Optibond Fl.
Device ID | K031444 |
510k Number | K031444 |
Device Name: | OPTIBOND FL |
Classification | Agent, Tooth Bonding, Resin |
Applicant | KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. Orange, CA 92867 |
Contact | Colleen Boswell |
Correspondent | Colleen Boswell KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. Orange, CA 92867 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-07 |
Decision Date | 2003-07-02 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
OPTIBOND FL 74666789 1962023 Live/Registered |
Kerr Corporation 1995-04-28 |