# K030168: Agc Cem

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Mar 21, 2003 after 63 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: 2 generations back to K924151 (1992). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012316: Permacem / Permacem Dual, Dmg USA, Inc. (2001)

## Indications for use
AGC@Cem is a dental self-curing compomer cement for the permanent cementation of AGC@Supracaps in tertiary structures such as secondary telescopic crowns in chrome cobalt substructures, or Supracaps in implant supraconstructions.

Source page: https://510kreport.com/device/K030168
Methodology: https://510kreport.com/methodology