# K020115: Pulpdent Sealant/Paste Orthodontic Bracket Adhesive System

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Feb 28, 2002 after 48 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) GAC AccuBond Sealant/Paste Bonding System: named in the summary without a submission number
- (no number) GAC ExactaBond Sealant/Paste Bonding System: named in the summary without a submission number
- (no number) Reliance Excel Bonding Adhesive: named in the summary without a submission number
- (no number) Reliance Phase 11 Sealant/Paste System: named in the summary without a submission number
- (no number) 3M Concise Orthodontic Bond System: named in the summary without a submission number

## Indications for use
PULPDENT Sealant/Paste Orthodontic Bracket Adhesive System is a self-cure, two-paste dental adhesive used with a self-cure, two-part sealant to adhere orthodontic brackets to tooth surfaces.

Source page: https://510kreport.com/device/K020115
Methodology: https://510kreport.com/methodology