# K190724: MD-Temp Plus

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Jul 3, 2019 after 105 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: 3 generations back to K001114 (2000). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061530: MD-Temp, Meta Biomed Co., Ltd. (2006) Summary page 4.

## Indications for use
For fabrication of temporary fillings and other temporary prosthetics for use until the permanent prosthetic is ready for insertion. intended to temporarily restore carious lesions or structural defects in teeth. Intended for use in cavities, Class I, IL IIL, IV (inlays and onlays).

Source page: https://510kreport.com/device/K190724
Methodology: https://510kreport.com/methodology