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 |