Fixtemp® C&B 4:1— 510(k) K241226

Substantially Equivalent

Dreve Denatmid GmbH

FDA 510(k) clearance K241226 for Fixtemp® C&B 4:1, Substantially Equivalent on 2024-05-31. Applicant: Dreve Denatmid GmbH. Device class: 2.

Clearance details

Applicant: Dreve Denatmid GmbH
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2024-05-02
Decision date: 2024-05-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Nordrhein-Westfalen, 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.