# K201683: PMMA Block

- Pathway: 510(k) (Traditional)
- Applicant: Huge Dental Material Co., Ltd.
- Decided: Nov 3, 2020 after 134 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K924830 (1994). 5 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150432: Idodentine Disc, Idodentine Block, Union Dental S.A. (2015) Summary page 4.

## Most influential descendants
- K223706: Pmma Block (2023), 1 descendant of its own
- K253380: “FLNT Base” and “FLNT Temp” (2026), 0 descendants of its own

## Indications for use
PMMA BLOCK particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM. Indications for Use: - Temporary anterior and posterior crowns; - Temporary anterior and posterior bridges; - Implant surgical guide; - Removable structures for dentures; - Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).

Source page: https://510kreport.com/device/K201683
Methodology: https://510kreport.com/methodology