Data / Medical devices / Mexico / Clemde S.A. De C.V.
Clemde S.A. De C.V.: FDA-registered device maker in MEXICO, DF Ciudad de Mexico, Mexico, 1 510(k) clearance
Clemde S.A. De C.V. is registered with the FDA (registration 3008494285) in MEXICO, DF Ciudad de Mexico, Mexico. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 27, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008494285
- Address
- AV. LA FORTUNA No.136 COL INDUSRRIAL C.P C.P., MEXICO, DF Ciudad de Mexico, Mexico, 07800
- Owner or operator
- CLEMDE S.A. DE C.V. (10033284)
- Roles
- Manufacturer
- First device listed
- December 9, 2016
- Registered through
- 2026
- Brand names listed
- PF Keep / Cad Cam Peek Block, Partial Flex
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Denture Preformed (Partially Prefabricated Denture) | EKO | 2 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 27, 2023 | K233171 | PF Keep; Cad Cam Keep Block | EBI | Substantially Equivalent | Clemde SA DE CV | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Material, Tooth Shade, Resin
- All makers of Denture Preformed (Partially Prefabricated Denture)
Updated November 27, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.