The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Belleglass Hp Opaceous Dentin.
Device ID | K000269 |
510k Number | K000269 |
Device Name: | BELLEGLASS HP OPACEOUS DENTIN |
Classification | Material, Tooth Shade, Resin |
Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
Contact | Colleen Boswell |
Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-01-28 |
Decision Date | 2000-03-23 |