The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Life And Life Fast Set.
Device ID | K961708 |
510k Number | K961708 |
Device Name: | LIFE AND LIFE FAST SET |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
Contact | William R Pike |
Correspondent | William R Pike SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92867 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-05-02 |
Decision Date | 1996-05-30 |