The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Tempfil C&b.
| Device ID | K964981 |
| 510k Number | K964981 |
| Device Name: | TEMPFIL C&B |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
| Contact | William R Pike |
| Correspondent | William R Pike SYBRON DENTAL SPECIALTIES, INC. 1717 WEST COLLINS AVE. Orange, CA 92667 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-12 |
| Decision Date | 1997-02-10 |
| Summary: | summary |