# K031915: Pulpdent Etch-Rite Royale

- Pathway: 510(k) (Traditional)
- Applicant: Pulpdent Corporation
- Decided: Aug 5, 2003 after 46 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.
14 later devices descend from it; 4 cite it directly.
0 of 15 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 Semi-Gel Etchant 35% Phosphoric acid Etchant: named in the summary without a submission number
- (no number) Pulpdent Etch-Rite 38 % Phosphoric Acid Etching Gel: named in the summary without a submission number

## Most influential descendants
- K062409: K-Etchant Gel (2006), 6 descendants of its own
- K152110: e-1 etchants (2015), 4 descendants of its own
- K172953: Acid Etchant (2018), 3 descendants of its own
- K242675: FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) (2024), 1 descendant of its own
- K192273: DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit (2020), 1 descendant of its own

## Indications for use
Pulpdent Etch-Rite Royale is a 37% phosphoric acid etchant in gel form that is used by the dental professional for etching dentin or enamel before tooth restoration. Etch-Rite Royale is dark blue for contrast with tooth enamel and easy visualization. Etch-Rite Royale is a soft gel that is easily manipulated and that rinses completely without leaving any residue.

Source page: https://510kreport.com/device/K031915
Methodology: https://510kreport.com/methodology