MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM— 510(k) K080311

Name: FDA 510(k) clearance K080311
Creator: U.S. Food and Drug Administration
Published: 2008-04-18

Substantially Equivalent

Dentsply Interntional

FDA 510(k) clearance K080311 for MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM, Substantially Equivalent on 2008-04-18. Applicant: Dentsply Interntional. Device class: 2.

Clearance details

Applicant: Dentsply Interntional
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2008-02-06
Decision date: 2008-04-18
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.