Sirona Dental CAD/CAM System with InLab Software— 510(k) K200191

Name: FDA 510(k) clearance K200191
Creator: U.S. Food and Drug Administration
Published: 2020-08-19

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K200191 for Sirona Dental CAD/CAM System with InLab Software, Substantially Equivalent on 2020-08-19. Applicant: Dentsply Sirona. Device class: 2.

Clearance details

Applicant: Dentsply Sirona
Product code: Code PNP
Device class: Class 2
Regulation: 21 CFR 872.3630
Advisory panel: Dental
Date received: 2020-01-27
Decision date: 2020-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, 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.