CharmFil— 510(k) K193496

Substantially Equivalent

Dentkist, Inc.

FDA 510(k) clearance K193496 for CharmFil, Substantially Equivalent on 2020-05-06. Applicant: Dentkist, Inc.. Device class: 2.

Clearance details

Applicant: Dentkist, Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2019-12-17
Decision date: 2020-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gunpo-Si, KR

Download summary PDF View on FDA.gov ↗

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More clearances from Dentkist, Inc.

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