DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)— 510(k) K222741

Name: FDA 510(k) clearance K222741
Creator: U.S. Food and Drug Administration
Published: 2022-11-07

Substantially Equivalent

Hdi, Inc.

FDA 510(k) clearance K222741 for DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast), Substantially Equivalent on 2022-11-07. Applicant: Hdi, Inc.. Device class: 2.

Clearance details

Applicant: Hdi, Inc.
Product code: Code ELW
Device class: Class 2
Regulation: 21 CFR 872.3660
Advisory panel: Dental
Date received: 2022-09-09
Decision date: 2022-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

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