DeltaFil, DeltaFil Conditioner— 510(k) K213201

Name: FDA 510(k) clearance K213201
Creator: U.S. Food and Drug Administration
Published: 2022-06-01

Substantially Equivalent

DMG Chemisch-Pharmazeutische Fabrik GmbH

FDA 510(k) clearance K213201 for DeltaFil, DeltaFil Conditioner, Substantially Equivalent on 2022-06-01. Applicant: DMG Chemisch-Pharmazeutische Fabrik GmbH. Device class: 2.

Clearance details

Applicant: DMG Chemisch-Pharmazeutische Fabrik GmbH
Product code: Code EMA
Device class: Class 2
Regulation: 21 CFR 872.3275
Advisory panel: Dental
Date received: 2021-09-29
Decision date: 2022-06-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hamburg, DE

Download summary PDF View on FDA.gov ↗

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