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FDA 510(k)

Harvest Printable Resin

K-Number: K222489 · 2023-05-12

Decision Date2023-05-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Harvest Printable Resin is a medical device manufactured by Harvest Dental Products, LLC. It received FDA 510(k) clearance on 2023-05-12 under approval number K222489. 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 Harvest Printable Resin?

Harvest Printable Resin is a medical device that received FDA 510(k) clearance on 2023-05-12. It is manufactured by Harvest Dental Products, LLC. The 510(k) number is K222489.

When was Harvest Printable Resin approved by the FDA?

Harvest Printable Resin received FDA 510(k) clearance on 2023-05-12, under approval number K222489.

What company makes Harvest Printable Resin?

Harvest Printable Resin is manufactured by Harvest Dental Products, LLC.

What is the FDA product code for Harvest Printable Resin?

The FDA product code for Harvest Printable Resin is EBI.

Other Devices by Harvest Dental Products, LLC

Related Devices (Code: EBI)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.