# K040994: Cosmedent Core Paste

- Pathway: 510(k) (Traditional)
- Applicant: Cosmedent, Inc.
- Decided: Jun 3, 2004 after 48 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) Den-Mat Core Paste: named in the summary without a submission number
- (no number) Bisco Bis-Core: named in the summary without a submission number
- (no number) Bisco Bisfil Core: named in the summary without a submission number

## Indications for use
Dental core buildup material for use with 4th or 5th generation resin adhesive primer/bonding systems.

Source page: https://510kreport.com/device/K040994
Methodology: https://510kreport.com/methodology