# K213093: STEP-1 PumEtch

- Pathway: 510(k) (Traditional)
- Applicant: Rounding Third, LLC
- Decided: Jan 28, 2022 after 126 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
Longest line of descent: 1 generation back to K141839 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141839: Premier Etch, Premier Dental Products Co. (2014) Summary page 4.

## Indications for use
STEP-1 PumEtch is a prophylaxis and phosphoric acid etchant treatment intended for the surface preparation of dentin or enamel prior to tooth restoration, including the application of sealants or for bonding.

Source page: https://510kreport.com/device/K213093
Methodology: https://510kreport.com/methodology