# K160918: JUVORA Dental Disc, Ceramill PEEK by JUVORA

- Pathway: 510(k) (Traditional)
- Applicant: Juvora
- Decided: Feb 13, 2017 after 315 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: 3 generations back to K043504 (2005). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132725: Juvora Dentqal Disc, Juvora (2014) Summary page 5.

## Most influential descendants
- K220329: G-CAM (2022), 1 descendant of its own
- K253236: G-Block (2025), 0 descendants of its own
- K233171: PF Keep; Cad Cam Keep Block (2023), 0 descendants of its own

## Indications for use
The JUVORA™ Dental Disc is a thermoplastic dental disc. They are intended to be used for the manufacture of: i) full and partial removable dentures and implant overdentures. ii) copings, substructures (cemented or uncemented), frameworks for permanent and transitional anterior or posterior crowns and bridgework.

Source page: https://510kreport.com/device/K160918
Methodology: https://510kreport.com/methodology