# K992956: Lucitone FRS Flexibel Dental Resin

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Oct 6, 1999 after 34 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.
12 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Valplast® Resin Material: named in the summary without a submission number

## Most influential descendants
- K123220: Vertex Thermosens Rigid (2013), 10 descendants of its own
- K132725: Juvora Dentqal Disc (2014), 8 descendants of its own
- K160918: JUVORA Dental Disc, Ceramill PEEK by JUVORA (2017), 3 descendants of its own
- K152113: BioHPP - breCAM.BioHPP (2016), 3 descendants of its own
- K220329: G-CAM (2022), 1 descendant of its own

## Indications for use
Used for fabrication of partial or full removable dentures, as well as occlusal splints and night guards.

Source page: https://510kreport.com/device/K992956
Methodology: https://510kreport.com/methodology