Manufacturer registered with FDA
Clemde SA DE CV
MEXICO CITY, Mexico. Lists 4 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 22023–2025
- Markets registered in
- 1United States
- Establishments
- 1Mexico
510(k) clearances per year, 2007–2026
Devices listed with FDA
What Clemde SA DE CV currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | PF Keep / Cad Cam Peek Block | 2024 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | PF Keep / Cad Cam Peek Block | 2024 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | PF Keep / Cad Cam Peek Block | 2024 |
| Denture Preformed (Partially Prefabricated Denture)EKO · Class 2 | Denture resins & teeth | Maker | Partial Flex | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| CLEMDE S.A. DE C.V.FDA reg. 3008494285 | MEXICO, DF Ciudad de Mexico, Mexico | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033284). 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.