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FDA 510(k)

Any-Etch

K-Number: K260485 · 2026-05-14

ApplicantMediclus Co., Ltd.
Decision Date2026-05-14
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Any-Etch is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2026-05-14 under 510(k) number K260485. 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 Any-Etch?

Any-Etch is a medical device that received FDA 510(k) clearance on 2026-05-14. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K260485.

When did Any-Etch receive FDA 510(k) clearance?

Any-Etch received FDA 510(k) clearance on 2026-05-14, under 510(k) number K260485.

Who is the listed applicant for Any-Etch?

The FDA 510(k) record lists Mediclus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Any-Etch?

The FDA product code for Any-Etch is KLE.

Other records listing Mediclus Co., Ltd. as applicant

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.

K254201Any-CemK261728One-Fil LCK260819Any-Com SealK253797One-StopK253167Any-PasteK252465Any-Core

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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.

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 AGK252469MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCADmp Dental Industry S.A.

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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