# K233171: PF Keep; Cad Cam Keep Block

- Pathway: 510(k) (Traditional)
- Applicant: Clemde SA DE CV
- Decided: Nov 27, 2023 after 60 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K043504 (2005). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160918: JUVORA Dental Disc, Ceramill PEEK by JUVORA, Juvora (2017) Summary page 5.

## Indications for use
PF KEEP / CAD CAM BLOCK IS A THERMO PLASTIC MATERIAL. THEY ARE INTENDED TO BE USED FOR THE MANUFACTURE OF: FULL AND PARTIAL REMOVABLE DENTURES AND IMPLANT OVERDENTURES INCOPINGS, SUBSTRUCTURES (CEMENTED OR UNCEMENTED), FRAMEWORKS FOR PERMANENT AND TRANSITIONAL ANTERIOR OR POSTERIOR CROWNS AND BRIDGEWORKS.

Source page: https://510kreport.com/device/K233171
Methodology: https://510kreport.com/methodology