# K030646: Belleglass Point 4

- Pathway: 510(k) (Traditional)
- Applicant: Kerr Dental Materials Center
- Decided: May 6, 2003 after 67 days
- Product code: EBD (Coating, Filling Material, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3310
- 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) belleGlass HP Enamel 2: named in the summary without a submission number
- (no number) belleGlass HP Translucent Dentin: named in the summary without a submission number

## Indications for use
The intended use of belleGlass Point 4 is to be used with the belleGlass HP (heat and pressure) crown and bridge fabrication system to produce high wear resistance and permanent surface luster for composite crowns and bridges. belleGlass Point 4 may be used by itself or in conjunction with gold, Captek, non precious metal or a fiber re-enforced substructure.

Source page: https://510kreport.com/device/K030646
Methodology: https://510kreport.com/methodology