# K954115: Artglass & Kevloc

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Sep 27, 1995 after 58 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 5 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K982164: Estenia (1998), 18 descendants of its own
- K012707: Estenia (2001), 17 descendants of its own
- K982259: Chroma Zone Color Stain (1998), 15 descendants of its own
- K012737: Chroma Zone Color Stain (2001), 14 descendants of its own
- K042929: Estenia C&B (2004), 12 descendants of its own

Source page: https://510kreport.com/device/K954115
Methodology: https://510kreport.com/methodology