PREXION 3D— 510(k) K120948

Substantially Equivalent

The Yoshida Dental Mfg. Co., Ltd.

FDA 510(k) clearance K120948 for PREXION 3D, Substantially Equivalent on 2012-12-21. Applicant: The Yoshida Dental Mfg. Co., Ltd.. Device class: 2.

Clearance details

Applicant: The Yoshida Dental Mfg. Co., Ltd.
Product code: Code OAS
Device class: Class 2
Regulation: 21 CFR 892.1750
Advisory panel: Radiology
Date received: 2012-03-29
Decision date: 2012-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

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