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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 the device name listed in this FDA 510(k) record. The listed applicant is Rounding Third, LLC. It received FDA 510(k) clearance on 2022-01-28 under 510(k) 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. The listed applicant is Rounding Third, LLC. The 510(k) number is K213093.

When did STEP-1 PumEtch receive FDA 510(k) clearance?

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

Who is the listed applicant for STEP-1 PumEtch?

The FDA 510(k) record lists Rounding Third, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: KLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

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.

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