Manufacturer registered with FDA
Protech Professional Products, Inc.
Boynton Beach, FL, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 21993–2015
- Markets registered in
- 1United States
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Devices listed with FDA
What Protech Professional Products, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | ProTech Plus Self Cure Hard Reline and Repair AcrylicProTech UBAR Metal Bonding Acrylic | 2019 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | PROTECH CONCENTRATSMILE AGAIN | 2003 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Protech Professional Products, Inc. as the applicant.
Also lists devices cleared under other names
Protech Professional Products, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Yamahachi Dental Manufacturing Co. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 12 Jul 2013 | K131036 | YAMAHACHI DENTURE BASE RESINS | Yamahachi Dental Manufacturing Co. | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PROTECH PROFESSIONAL PRODUCTS, INC.FDA reg. 2435952 | BOYNTON BEACH, FL, United States | Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9006187). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.