# K030036: Triple-Cure Paste/Paste Resin-Reinforced Glass Ionomer Cement

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Mar 12, 2003 after 68 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) Pulpdent Triple-Cure Reinforced Glass Ionomer Orthodontic Cement: named in the summary without a submission number
- (no number) GC Fuji Ortho (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 Paste / Paste Resin-Reinforced Glass Ionomer Cement is used to adhere orthodontic brackets and bands to teeth, to cement metallic restorations and as a base and liner under restorations. It combines the advantages of a glass ionomer cement with the added strength of dental resin technology. Triple-Cure Paste / Paste is a fluoride-releasing, light-cure, self-cure, glass ionomer dental cement in two paste form. It is not recommended for post cementation or veneer cementation.

Source page: https://510kreport.com/device/K030036
Methodology: https://510kreport.com/methodology