The following data is part of a premarket notification filed by Protech Professional Products, Inc. with the FDA for Permaflex Permanent Soft Denture Reliner.
Device ID | K925062 |
510k Number | K925062 |
Device Name: | PERMAFLEX PERMANENT SOFT DENTURE RELINER |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | PROTECH PROFESSIONAL PRODUCTS, INC. 12 LYNHAVEN PLACE Centereach, NY 11720 |
Contact | Barry Bloch |
Correspondent | Barry Bloch PROTECH PROFESSIONAL PRODUCTS, INC. 12 LYNHAVEN PLACE Centereach, NY 11720 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-06 |
Decision Date | 1993-03-31 |