# K103351: DMC Composite 2

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Corporation
- Decided: Jan 20, 2011 after 65 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) Premise Flowable: named in the summary without a submission number
- (no number) Optibond Solo Plus Z: named in the summary without a submission number

## Indications for use
DMC Composite 2 High Viscosity is intended for direct restorations of all caries classes. Additional indications include core buildup material, small endo access restorations, repair of porcelain restorations, repair of composite restorations and acrylic restorations, and repair of temporaries. DMC Composite 2 Low Viscosity is intended for Class I and 11(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 occiusal build-ups in non-stress bearing areas, incisal abrasions, small endo access restorations, repair of composite and acrylic restorations, and repair of temporaries.

Source page: https://510kreport.com/device/K103351
Methodology: https://510kreport.com/methodology