# K061530: MD-Temp

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: Jul 21, 2006 after 49 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: 2 generations back to K001114 (2000). 6 ancestors in all.
1 later device descends 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)
- K033022: Protemp 3 Garant, 3M Espe AG Dental Products (2003) Summary page 1.
- K024282: Acrylic, Inovativ, LLC (2003) Summary page 1.
- K002364: Protemp H, Espe Dental AG (2000) Summary page 1.
- K001309: Hydro-Cast Bis-Acryl Temporary Crown and Bridge Material, Model 98250, Kay See Dental Mfg. Co. (2000) Summary page 1.
- K875133: Cavit-W, Espe GmbH (Us) (1988) Summary page 1.

## Most influential descendants
- K190724: MD-Temp Plus (2019), 0 descendants of its own

## Indications for use
For fabrication of temporary fillings and other temporary prosthetics for use until the permanent prosthetic is ready for installation. Intended to restore carious lesions or structural defects in teeth temporarily. Intended for use in cavities Classes I, II, III, IV (inlays and onlays) and as a restorative material for veneers, crowns and bridges.

Source page: https://510kreport.com/device/K061530
Methodology: https://510kreport.com/methodology