510(k) · Cleared
ClearedSTEP-1 PumEtch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rounding Third, LLC · KLE Agent, Tooth Bonding, Resin
Cleared on Jan 28, 2022 as substantially equivalent to K141839 (Premier Dental Products Co., 2014) after a 126-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- Jan 28, 2022
- Review
- 126 days
- Class
- Class II
- Product code
- KLE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K141839 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK141839 Premier EtchPremier Dental Products Co. · 2014
- This deviceK213093 STEP-1 PumEtchRounding Third, LLC · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K141839 | Premier Etch | Premier Dental Products Co. | 2014 | — |
| 0 (this device) | K213093 | STEP-1 PumEtch | Rounding Third, LLC | 2022 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KLE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KLE device
- #1 K262252 MPa Max adhesivescore 15.1 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K141839 | Premier EtchSummary page 4…oduct Code: KLE, EJR Predicate Device: Premier Etch 510(k) Applicant: Premier Dental Company Products 510(k): K141839 Primary Reference Device: Enamel Pro 510(k) Applicant: Premier Dental Company Products 510(k):… | 2014 |
| † | K062166 | Enamel Pro | 2006 |
| † | K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A… | 2020 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All KLE devicesKLE Agent, Tooth Bonding, Resin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KLE
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KLE
149in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KLE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLE
3in 2025
MAUDE reports naming product code KLE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 71 | 2 | 18 |
| 2008 | 3 | 66 | 0 | 9 |
| 2009 | 7 | 79 | 1 | 11 |
| 2010 | 8 | 93 | 1 | 13 |
| 2011 | 10 | 100 | 0 | 69 |
| 2012 | 5 | 66 | 0 | 176 |
| 2013 | 11 | 115 | 0 | 248 |
| 2014 | 6 | 120 | 0 | 260 |
| 2015 | 10 | 118 | 0 | 100 |
| 2016 | 3 | 148 | 1 | 47 |
| 2017 | 4 | 171 | 1 | 42 |
| 2018 | 8 | 124 | 0 | 31 |
| 2019 | 6 | 143 | 0 | 20 |
| 2020 | 6 | 195 | 0 | 6 |
| 2021 | 4 | 163 | 0 | 6 |
| 2022 | 8 | 98 | 0 | 7 |
| 2023 | 6 | 75 | 0 | 7 |
| 2024 | 7 | 61 | 1 | 12 |
| 2025 | 3 | 149 | 0 | 3 |
| 2026 | 7 | 84 | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213093: STEP-1 PumEtch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213093
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026