Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STEP-1 PumEtch

K-Number: K213093 · 2022-01-28

ApplicantRounding Third, LLC
Decision Date2022-01-28
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

STEP-1 PumEtch is a medical device manufactured by Rounding Third, LLC. It received FDA 510(k) clearance on 2022-01-28 under approval number K213093. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEP-1 PumEtch?

STEP-1 PumEtch is a medical device that received FDA 510(k) clearance on 2022-01-28. It is manufactured by Rounding Third, LLC. The 510(k) number is K213093.

When was STEP-1 PumEtch approved by the FDA?

STEP-1 PumEtch received FDA 510(k) clearance on 2022-01-28, under approval number K213093.

What company makes STEP-1 PumEtch?

STEP-1 PumEtch is manufactured by Rounding Third, LLC.

What is the FDA product code for STEP-1 PumEtch?

The FDA product code for STEP-1 PumEtch is KLE.

Related Devices (Code: KLE)

K161891HC PrimerShofu Dental Corporation K161042CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value packKuraray Noritake Dental, Inc. K161051All-Bond Universal w/BAC (not finalized)Bisco, Inc. K171226TOKUYAMA UNIVERSAL BONDTokuyama Dental Corporation K172176Parkell Universal AdhesiveParkell, Inc. K172106SHOFU MZ Primer PlusShofu Dental Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑