DYRACT EXTRA RESTORATIVE— 510(k) K050880

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K050880 for DYRACT EXTRA RESTORATIVE, Substantially Equivalent on 2005-04-22. Applicant: Dentsply Intl.. Device class: 2.

Clearance details

Applicant: Dentsply Intl.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2005-04-06
Decision date: 2005-04-22
Decision: Substantially Equivalent
Clearance type: Special
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.