# K014138: Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic Cement

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Mar 14, 2002 after 87 days
- Product code: DYH (Adhesive, Bracket And Tooth Conditioner, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3750
- 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) GC Fuji Ortho LC (light-cure): named in the summary without a submission number
- (no number) GC Fuji Ortho Self-cure: named in the summary without a submission number
- (no number) Pulpdent Band-Rite: named in the summary without a submission number

## Indications for use
PULPDENT Triple-Cure™ Reinforced Glass lonomer Orthodontic Cement is a multi-purpose orthodontic cement that can be used as a bracket adhesive and as a band cement. It combines the advantages of glass ionomer cement with the added strength of dental resin technology. Triple-Cure™ is a fluoride releasing, light-cure, self-cure, glass ionomer dental adhesive in powder and liquid form. It is used with an enamel etching gel to adhere orthodontic brackets to tooth surfaces

Source page: https://510kreport.com/device/K014138
Methodology: https://510kreport.com/methodology