# K013009: Belleglass HP DC Opaceous Dentin Lcte 2

- Pathway: 510(k) (Traditional)
- Applicant: Sybron Dental Specialties, Inc.
- Decided: Oct 3, 2001 after 27 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) Kerr Corporation, belleGlass HP DC Opaceous Dentin LCTE: named in the summary without a submission number

## Indications for use
belleGlass HP DC Opaceous Dentin LCTE 2 is a dual cured composite material for use with the belleGlass HP (heat and pressure) crown and bridge fabrication system where a more durable base for composite crowns and bridges is desired.

Source page: https://510kreport.com/device/K013009
Methodology: https://510kreport.com/methodology