The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Tempfil F.
Device ID | K963786 |
510k Number | K963786 |
Device Name: | TEMPFIL F |
Classification | Crown And Bridge, Temporary, Resin |
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 | EBG |
CFR Regulation Number | 872.3770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-20 |
Decision Date | 1996-11-19 |
Summary: | summary |