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FDA 510(k)

Porcelain Etch Gel

K-Number: K260430 · 2026-04-10

ApplicantBelport Company, Inc., Gingi-Pak
Decision Date2026-04-10
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Porcelain Etch Gel is the device name listed in this FDA 510(k) record. The listed applicant is Belport Company, Inc., Gingi-Pak. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260430. 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 Porcelain Etch Gel?

Porcelain Etch Gel is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is Belport Company, Inc., Gingi-Pak. The 510(k) number is K260430.

When did Porcelain Etch Gel receive FDA 510(k) clearance?

Porcelain Etch Gel received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260430.

Who is the listed applicant for Porcelain Etch Gel?

The FDA 510(k) record lists Belport Company, Inc., Gingi-Pak as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Porcelain Etch Gel?

The FDA product code for Porcelain Etch Gel is KLE.

Other records listing Belport Company, Inc., Gingi-Pak as applicant

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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.

K260485Any-EtchMediclus Co., Ltd.K252450Adhese 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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