# K020514: Pulpdent Glaze II

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: May 16, 2002 after 90 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- 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 Resin Bonding Agent: named in the summary without a submission number
- (no number) Bisco Fortify: named in the summary without a submission number
- (no number) UltraDent PermaSeal: named in the summary without a submission number

## Indications for use
Pulpdent Glaze II is a light-cured, unfilled resin that contains no Bisphenol A and is used as a penetrating composite sealer and bonding agent. Pulpdent Glaze II bonds to composite and etched enamel, seals composite margins, penetrates and seals composite surface, reducing micro-leakage, wear and marginal breakdown.

Source page: https://510kreport.com/device/K020514
Methodology: https://510kreport.com/methodology