# K123826: Vitro Molar

- Pathway: 510(k) (Traditional)
- Applicant: Dfl Industria E Comercio SA
- Decided: Feb 14, 2013 after 64 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 K843566 (1984). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961448: Fuji IX GP, GC America, Inc. (1996) Summary page 1.
- K960954: Ketac-Molar Aplicap, Espe GmbH & Co. Kg. (1996) Summary page 1.

## Indications for use
Class I, Class II, Class III and Class V restorations Non-bearing Class I and Class II restorations in permanent teeth Intermediate restoration for heavy stress situations in Class I and Class II cavities Core build up Liner

Source page: https://510kreport.com/device/K123826
Methodology: https://510kreport.com/methodology