The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Fill-in.
Device ID | K031476 |
510k Number | K031476 |
Device Name: | FILL-IN |
Classification | Crown And Bridge, Temporary, Resin |
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 | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-05-09 |
Decision Date | 2003-07-02 |
Summary: | summary |