The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Reprodent.
Device ID | K790325 |
510k Number | K790325 |
Device Name: | REPRODENT |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | PREMIER DENTAL PRODUCTS CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-15 |
Decision Date | 1979-03-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
REPRODENT 73313939 1225685 Dead/Cancelled |
BonyF Aktiengesellschaft 1981-06-08 |