Harvest Dental Polymer Blocks
K-Number: K180578 · 2018-12-12
ApplicantHarvest Dental Products, LLC
Decision Date2018-12-12
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Harvest Dental Polymer Blocks is a medical device manufactured by Harvest Dental Products, LLC. It received FDA 510(k) clearance on 2018-12-12 under approval number K180578. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Harvest Dental Polymer Blocks?
Harvest Dental Polymer Blocks is a medical device that received FDA 510(k) clearance on 2018-12-12. It is manufactured by Harvest Dental Products, LLC. The 510(k) number is K180578.
When was Harvest Dental Polymer Blocks approved by the FDA?
Harvest Dental Polymer Blocks received FDA 510(k) clearance on 2018-12-12, under approval number K180578.
What company makes Harvest Dental Polymer Blocks?
Harvest Dental Polymer Blocks is manufactured by Harvest Dental Products, LLC.
What is the FDA product code for Harvest Dental Polymer Blocks?
The FDA product code for Harvest Dental Polymer Blocks is EBG.
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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.