The following data is part of a premarket notification filed by Protech, Inc. with the FDA for Protech Plus.
| Device ID | K983547 |
| 510k Number | K983547 |
| Device Name: | PROTECH PLUS |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | PROTECH, INC. 6421 CONGRESS AVENUE, #102 Boca Raton, FL 33487 |
| Contact | Barry Bloch |
| Correspondent | Barry Bloch PROTECH, INC. 6421 CONGRESS AVENUE, #102 Boca Raton, FL 33487 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-09 |
| Decision Date | 1999-01-07 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PROTECH PLUS 85927349 4454716 Live/Registered |
Unifirst Corporation 2013-05-09 |