# K991577: Nic Tone Acrylic Resins

- Pathway: 510(k) (Traditional)
- Applicant: Manufacturera Dental Continental
- Decided: Sep 22, 1999 after 139 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
Nic Tone Acrylic Resins are used in the fabrication, repair or rebasing of complete or partial removable dentures, the fabrication of veneer crowns, the fabrication of orthodontic devices, and the fabrication of temporary crowns and bridges.

Source page: https://510kreport.com/device/K991577
Methodology: https://510kreport.com/methodology