Harvest Conceal ZR Block Out
K-Number: K222961 · 2023-06-02
ApplicantHarvest Dental Products, LLC
Decision Date2023-06-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Harvest Conceal ZR Block Out is a medical device manufactured by Harvest Dental Products, LLC. It received FDA 510(k) clearance on 2023-06-02 under approval number K222961. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Harvest Conceal ZR Block Out?
Harvest Conceal ZR Block Out is a medical device that received FDA 510(k) clearance on 2023-06-02. It is manufactured by Harvest Dental Products, LLC. The 510(k) number is K222961.
When was Harvest Conceal ZR Block Out approved by the FDA?
Harvest Conceal ZR Block Out received FDA 510(k) clearance on 2023-06-02, under approval number K222961.
What company makes Harvest Conceal ZR Block Out?
Harvest Conceal ZR Block Out is manufactured by Harvest Dental Products, LLC.
What is the FDA product code for Harvest Conceal ZR Block Out?
The FDA product code for Harvest Conceal ZR Block Out is EIH.
Other Devices by Harvest Dental Products, LLC
Related Devices (Code: EIH)
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.