Pour Acrylic
K-Number: K161330 · 2016-10-06
ApplicantDentsply Sirona
Decision Date2016-10-06
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Pour Acrylic is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2016-10-06 under approval number K161330. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Pour Acrylic?
Pour Acrylic is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Dentsply Sirona. The 510(k) number is K161330.
When was Pour Acrylic approved by the FDA?
Pour Acrylic received FDA 510(k) clearance on 2016-10-06, under approval number K161330.
What company makes Pour Acrylic?
Pour Acrylic is manufactured by Dentsply Sirona.
What is the FDA product code for Pour Acrylic?
The FDA product code for Pour Acrylic is EBI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.