# K061501: Flexo Dental Resin Material

- Pathway: 510(k) (Traditional)
- Applicant: Aci, Inc.
- Decided: Jul 26, 2006 after 56 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 K992956 (1999). 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)
- K992956: Lucitone FRS Flexibel Dental Resin, Dentsply Intl. (1999) Summary page 1.
- (no number) Valplast Resin Material: named in the summary without a submission number

## Indications for use
Flexo Dental Resin Material is intended to fabricate partial or full removable dentures, as well as occlusal splints and night guards.

Source page: https://510kreport.com/device/K061501
Methodology: https://510kreport.com/methodology