# K022492: Pulpdent Semi-Gel Etch

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Oct 11, 2002 after 74 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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 Etch-Rite 38% Phosphoric Acid Etching Gel: named in the summary without a submission number
- (no number) Pulpdent Etch-All 10% Phosphoric Acid Etching Gel: named in the summary without a submission number
- (no number) Ortho Direct Enamel Etch: named in the summary without a submission number

## Most influential descendants
- K080305: Nexcomp and Meta Etchant (2008), 1 descendant of its own
- K181689: Nexcomp (2018), 0 descendants of its own

## Indications for use
PULPDENT SEMI-GEL ETCH is a 35% phosphoric acid etchant in a viscous liquid form. It is used by the dental professional to etch dentin, enamel and glass ionomer cements.

Source page: https://510kreport.com/device/K022492
Methodology: https://510kreport.com/methodology