HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)— 510(k) K132937

Name: FDA 510(k) clearance K132937
Creator: U.S. Food and Drug Administration
Published: 2014-05-21

Substantially Equivalent

Harvest Dental Products, LLC

FDA 510(k) clearance K132937 for HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA), Substantially Equivalent on 2014-05-21. Applicant: Harvest Dental Products, LLC. Device class: 2.

Clearance details

Applicant: Harvest Dental Products, LLC
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2013-09-18
Decision date: 2014-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sarasota, FL, 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.