The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Enlight Lv.
Device ID | K984362 |
510k Number | K984362 |
Device Name: | ENLIGHT LV |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
Contact | Colleen Boswell |
Correspondent | Colleen Boswell SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-12-07 |
Decision Date | 1999-01-21 |
Summary: | summary |