DIRECT CROWN NATURAL 1— 510(k) K101814

Substantially Equivalent

Candulor USA, Inc.

FDA 510(k) clearance K101814 for DIRECT CROWN NATURAL 1, Substantially Equivalent on 2010-09-27. Applicant: Candulor USA, Inc.. Device class: 2.

Clearance details

Applicant: Candulor USA, Inc.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2010-06-29
Decision date: 2010-09-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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