# K062157: Conform

- Pathway: 510(k) (Traditional)
- Applicant: Apex Dental Materials, Inc.
- Decided: Oct 13, 2006 after 77 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
Longest line of descent: 1 generation back to K955292 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955292: Aeliteflo, Bisco, Inc. (1995) Summary page 1.

## Indications for use
CONFORMTM is a light cured (free radical polymerization), flowable composite material, designed for use as a filling material for small restorations, a sealant material for occlusal surfaces, or a lining material in the base of large restorations. CONFORMTM is a versatile composite material which, when utilized properly, provides a strong, wear resistant material for dental restorations. CONFORMTM can also be used as the initial filled layer or liner of a cavity restoration. When used as a liner, the material provides a strong base that assures the mechanical interface between the bonded tooth substrate and a highly filled composite are optimal. CONFORMTM is compatible with all other methacrylate based dental materials.

Source page: https://510kreport.com/device/K062157
Methodology: https://510kreport.com/methodology