# K973542: MASKY

- Pathway: 510(k) (Traditional)
- Applicant: Pressing DI Monticelli Rag. Stefano
- Decided: Feb 10, 1998 after 145 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: 1 generation back to K954115 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954115: Artglass & Kevloc, Heraeus Kulzer, Inc. (1995) Summary page 1.

## Indications for use
Masky is indicated for use when patients require a partial denture prosthetic that has a substantial amount of exposed metal in the frame. Masky covers exposed metal areas to reduce visual impact of framework in the mouth. Can also cover wires used in orthodontic appliances to make appliances less visible.

Source page: https://510kreport.com/device/K973542
Methodology: https://510kreport.com/methodology