# K243951: TEMP MASTER, PMMA-based dental resin

- Pathway: 510(k) (Traditional)
- Applicant: Taiwan Dental Materials Co., Ltd.
- Decided: Feb 21, 2025 after 60 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: 1 generation back to K073106 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073106: Unifast Iii, GC America, Inc. (2008) Summary page 6.

## Indications for use
TEMP MASTER, PMMA-based dental resin developed by Taiwan Dental Materials CO., LTD. is a self-cured resin indicated for the fabrication of short-term restorations including temporary inlays, crowns, and bridges, which can protect or restore damaged teeth while permanent restorations are being prepared. It is a traditional auto-cured PMMA-based resin composed of powder and liquid. Polymerization occurs when the powder and liquid are mixed at room temperature.

Source page: https://510kreport.com/device/K243951
Methodology: https://510kreport.com/methodology