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FDA 510(k)

DenMat Glutaraldehyde Desensitizer

K-Number: K222357 · 2022-08-09

ApplicantDenmat Holding, LLC
Decision Date2022-08-09
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DenMat Glutaraldehyde Desensitizer is the device name listed in this FDA 510(k) record. The listed applicant is Denmat Holding, LLC. It received FDA 510(k) clearance on 2022-08-09 under 510(k) number K222357. 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 DenMat Glutaraldehyde Desensitizer?

DenMat Glutaraldehyde Desensitizer is a medical device that received FDA 510(k) clearance on 2022-08-09. The listed applicant is Denmat Holding, LLC. The 510(k) number is K222357.

When did DenMat Glutaraldehyde Desensitizer receive FDA 510(k) clearance?

DenMat Glutaraldehyde Desensitizer received FDA 510(k) clearance on 2022-08-09, under 510(k) number K222357.

Who is the listed applicant for DenMat Glutaraldehyde Desensitizer?

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

What is the FDA product code for DenMat Glutaraldehyde Desensitizer?

The FDA product code for DenMat Glutaraldehyde Desensitizer is KLE.

Other records listing Denmat Holding, 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.

K251593DenMat Multilayered Zirconia Disc

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

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

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