# K172764: Keymill

- Pathway: 510(k) (Traditional)
- Applicant: Mycone Dental Supply Company, Inc. (Aka Keystone Industries)
- Decided: Apr 27, 2018 after 226 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Mycone Dental’s High-Impact Denture Acrylic CAD/CAM Milling Disc material, known as Keymill, is intended to be used to form new dentures. It is intended to be used only by professional dental practitioners who make dentures for patients.

Source page: https://510kreport.com/device/K172764
Methodology: https://510kreport.com/methodology