# K032773: Diamond D High Impact Denture Acrylic

- Pathway: 510(k) (Special)
- Applicant: Mycone Dental Supply Co., Inc.
- Decided: Sep 23, 2003 after 15 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 denture material, known as Diamond D, is intended to be used to form new dentures or to repair fractured dentures. It is to be used only by professional dental practitioners who make or repair dentures for patients.

Source page: https://510kreport.com/device/K032773
Methodology: https://510kreport.com/methodology