# K013824: Acry Plus, Acry Lux, Acry Lux V, Acry Rock, Acry Rock V and Z-Tone Preformed Plastic Denture Teeth

- Pathway: 510(k) (Traditional)
- Applicant: Dental Manufacturing S.P.A
- Decided: Jan 30, 2002 after 72 days
- Product code: ELM (Denture, Plastic, Teeth)
- Device class: 2
- Regulation: 21 CFR 872.3590
- 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
ACRY PLUS, ACRY LUX, ACRY LUX V, ACRY ROCK, ACRY ROCK V and Z-TONE Preformed Plastic Denture Teeth are prefabricated devices, composed of methyl methacrylate material, which are intended for use as teeth in a denture.

Source page: https://510kreport.com/device/K013824
Methodology: https://510kreport.com/methodology