# K153546: PINK CAD/CAM disc

- Pathway: 510(k) (Traditional)
- Applicant: Polident D.O.O., Dental Products Industry
- Decided: Sep 28, 2016 after 292 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: 5 generations back to K901789 (1990). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140758: M-PM-Disc (Pink), Merz Dental GmbH (2014) Summary page 4.

## Most influential descendants
- K172683: Yamahachi Pink CAD/CAM Disk (2018), 0 descendants of its own

## Indications for use
- Fabrication of dentures.

Source page: https://510kreport.com/device/K153546
Methodology: https://510kreport.com/methodology