The following data is part of a premarket notification filed by Sybron Dental Specialties, Inc. with the FDA for Soft Denture Rebasing Resin.
Device ID | K963736 |
510k Number | K963736 |
Device Name: | SOFT DENTURE REBASING RESIN |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
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 | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-09-17 |
Decision Date | 1996-12-04 |
Summary: | summary |