DenMat Glutaraldehyde Desensitizer— 510(k) K222357

Name: FDA 510(k) clearance K222357
Creator: U.S. Food and Drug Administration
Published: 2022-08-09

Substantially Equivalent

Denmat Holding, LLC

FDA 510(k) clearance K222357 for DenMat Glutaraldehyde Desensitizer, Substantially Equivalent on 2022-08-09. Applicant: Denmat Holding, LLC. Device class: 2.

Clearance details

Applicant: Denmat Holding, LLC
Product code: Code KLE
Device class: Class 2
Regulation: 21 CFR 872.3200
Advisory panel: Dental
Date received: 2022-08-04
Decision date: 2022-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lompoc, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.