# K171449: Metacem

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed Co., Ltd.
- Decided: May 15, 2018 after 363 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931812 (1993). 48 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081913: Metacem, Meta P&Bond, Metacem Silane Ceramic Primer, Meta Biomed Co., Ltd. (2008) Summary page 4.

## Most influential descendants
- K261166: Dia-Cem (2026), 0 descendants of its own

## Indications for use
Adhesive cementation of: * Crown & Bridges (Ceramic, Composite, Porcelain, Metal) * Inlay / Onlay cementation * Bonding for porcelain veneers * Endodontic posts cementation * Core build up

Source page: https://510kreport.com/device/K171449
Methodology: https://510kreport.com/methodology