STEP-1 PumEtch— 510(k) K213093

Substantially Equivalent

Rounding Third, LLC

FDA 510(k) clearance K213093 for STEP-1 PumEtch, Substantially Equivalent on 2022-01-28. Applicant: Rounding Third, LLC. Device class: 2.

Clearance details

Applicant: Rounding Third, LLC
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2021-09-24
Decision date: 2022-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Centennial, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.