# K983876: Millenium Sledgehammer, Formula 99 and Naturalyke H.C., High Impact Denture Acrylic

- Pathway: 510(k) (Traditional)
- Applicant: Mycone Dental Supply Co., Inc. (A/K/A Keystone Ind
- Decided: Dec 16, 1998 after 44 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
The denture materials manufactured by Keystone Industries are intended to be used to form new dentures or to repair fractured dentures. They are to be used only by professional dental practitioners who make or repair dentures for patients.

Source page: https://510kreport.com/device/K983876
Methodology: https://510kreport.com/methodology