# K993683: Pulpdent Uno-Duo

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corp.
- Decided: Dec 13, 1999 after 42 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 Uno: named in the summary without a submission number
- (no number) Pulpdent Dentastic: named in the summary without a submission number
- (no number) Dentsply / Caulk PRIME & BOND NT DUAL CURE: named in the summary without a submission number

## Indications for use
PULPDENT DENTASTIC UNO-DUO is a kit containing DenTASTIC UNO, a single-component light cure dental primer / bonding resin [K 974014] and a Dual Cure Catalyst [K 926074, K 931710]. PULPDENT UNO-DUO is used by the dentist to bond to dentin, enamel, metals and resins in those situations in which a dual cure product is indicated.

Source page: https://510kreport.com/device/K993683
Methodology: https://510kreport.com/methodology