# K020432: Pulpdent Glaze

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Apr 17, 2002 after 68 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) Pulpdent DenTASTIC UNO: named in the summary without a submission number
- (no number) Pulpdent Flows-Rite: named in the summary without a submission number
- (no number) UltraDent PermaSeal: named in the summary without a submission number
- (no number) UltraDent PermaQuick: named in the summary without a submission number
- (no number) Bisco Fortify: named in the summary without a submission number
- (no number) Kuraray Clear-Fil SE Bond: named in the summary without a submission number
- (no number) Kerr Opti Bond Solo Plus 3: named in the summary without a submission number

## Indications for use
Pulpdent Glaze is a light-cured resin that contains no Bisphenol A and bonds tightly to enamel and composite restorations. Pulpdent Glaze is offered in different formulations to meet the needs of the dental professional: filled, unfilled, very low filler level, no fluoride and fluoride-releasing. Pulpdent Glaze can be used to seal composite surfaces, margins of restorations, cracks in teeth and restorations and to reduce micro-leakage. Two formulas can be used for dentin bonding.

Source page: https://510kreport.com/device/K020432
Methodology: https://510kreport.com/methodology