# K081695: DMC Composite

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corp.
- Decided: Aug 12, 2008 after 56 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Premise: named in the summary without a submission number
- (no number) PremiseFlowable: named in the summary without a submission number

## Indications for use
DMC Composite High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, repair of porcelain restorations, and repair of composite restorations. DMC Composite Low Viscosity is intended for Class I and II (base/liner), Class III and Class V restorations. Additional indications include pit and fissure sealant, repair of enamel defects, repair of porcelain restorations, blocking out of undercuts, minor occlusal build-ups in non-stress bearing areas and incisal abrasions.

Source page: https://510kreport.com/device/K081695
Methodology: https://510kreport.com/methodology