FDA 510(k)

MPa Max adhesive

K-Number: K262252 · 2026-09-24

Decision Date2026-09-24

Product CodeKLE

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

MPa Max adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Holdings, LLC. It received FDA 510(k) clearance on 2026-09-24 under 510(k) number K262252. 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 MPa Max adhesive?

MPa Max adhesive is a medical device that received FDA 510(k) clearance on 2026-09-24. The listed applicant is Den-Mat Holdings, LLC. The 510(k) number is K262252.

When did MPa Max adhesive receive FDA 510(k) clearance?

MPa Max adhesive received FDA 510(k) clearance on 2026-09-24, under 510(k) number K262252.

Who is the listed applicant for MPa Max adhesive?

The FDA 510(k) record lists Den-Mat Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MPa Max adhesive?

The FDA product code for MPa Max adhesive is KLE.

Other records listing Den-Mat Holdings, LLC 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.

K242097DenMat Bulk Fill Composite K162967nuance UNIVERSAL

Related Devices (Code: KLE)

K260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products Company K251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

Official Source

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