# K150454: Acryfree Denture Base Material and Biosens Denture Base Material

- Pathway: 510(k) (Traditional)
- Applicant: Perflex
- Decided: May 26, 2015 after 95 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K213994: Flexible Block (2022), 1 descendant of its own
- K250302: Flexible Partial Resin (2025), 0 descendants of its own

## Indications for use
“Acryfree Denture Base Material” and “Biosens Denture Base Material” are intended for manufacturing, relining, repairing, and rebasing of partial or full removable dentures, dental plates, bite plates, personal trays, appliances, occlusal splints and night guards.

Source page: https://510kreport.com/device/K150454
Methodology: https://510kreport.com/methodology