# K141421: Pmma Block

- Pathway: 510(k) (Abbreviated)
- Applicant: Rizhao Huge Dental Industry Co., Ltd.
- Decided: Feb 9, 2015 after 255 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 K070991 (2007). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131664: Copra Temp Pmma-Disk, White Peaks Dental Systems GmbH & Co. KG (2013) Summary page 4.

## Most influential descendants
- K190217: Aidite PMMA (2020), 1 descendant of its own
- K223477: PMMA Blocks for Dental Use (2023), 0 descendants of its own

## Indications for use
PMMA Block is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.

Source page: https://510kreport.com/device/K141421
Methodology: https://510kreport.com/methodology