# K213994: Flexible Block

- Pathway: 510(k) (Traditional)
- Applicant: Shandong Huge Dental Material Corporation
- Decided: Mar 4, 2022 after 73 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 K150454 (2015). 1 ancestor in all.
1 later device descends 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)
- K150454: Acryfree Denture Base Material and Biosens Denture Base Material, Perflex (2015) Summary page 4.

## Most influential descendants
- K250302: Flexible Partial Resin (2025), 0 descendants of its own

## Indications for use
Intended for making dental plates, bite plates, frame-works, clasps,personal trays, appliances, occlusal splints and night guards.

Source page: https://510kreport.com/device/K213994
Methodology: https://510kreport.com/methodology