EVOLUX CAD/CAM PMMA BLOCKS— 510(k) K182065

Substantially Equivalent

Blue Dent Dental

FDA 510(k) clearance K182065 for EVOLUX CAD/CAM PMMA BLOCKS, Substantially Equivalent on 2018-12-13. Applicant: Blue Dent Dental. Device class: 2.

Clearance details

Applicant: Blue Dent Dental
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2018-08-01
Decision date: 2018-12-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pirassununga, BR

Download summary PDF View on FDA.gov ↗

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