DIRECT CROWN— 510(k) K001884

Substantially Equivalent

Flexible Dimensions, LLC

FDA 510(k) clearance K001884 for DIRECT CROWN, Substantially Equivalent on 2000-10-25. Applicant: Flexible Dimensions, LLC. Device class: 2.

Clearance details

Applicant: Flexible Dimensions, LLC
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2000-06-21
Decision date: 2000-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, 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.