510(k) K152652— PackFil Dual Cured Resin Modified Glass Ionomer Restorative Cement

Substantially Equivalent

Gaia Dental Products, Inc.

Clearance details

Applicant: Gaia Dental Products, Inc.
Product code: Code EMA
Advisory panel: Dental
Date received: 2015-09-16
Decision date: 2016-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Meriden, CT, US

Download summary PDF View on FDA.gov ↗

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