Harvest Dental HD Gum Strip
K-Number: K231389 · 2023-08-16
ApplicantHarvest Dental Products, LLC
Decision Date2023-08-16
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Harvest Dental HD Gum Strip is a medical device manufactured by Harvest Dental Products, LLC. It received FDA 510(k) clearance on 2023-08-16 under approval number K231389. 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 Dental HD Gum Strip?
Harvest Dental HD Gum Strip is a medical device that received FDA 510(k) clearance on 2023-08-16. It is manufactured by Harvest Dental Products, LLC. The 510(k) number is K231389.
When was Harvest Dental HD Gum Strip approved by the FDA?
Harvest Dental HD Gum Strip received FDA 510(k) clearance on 2023-08-16, under approval number K231389.
What company makes Harvest Dental HD Gum Strip?
Harvest Dental HD Gum Strip is manufactured by Harvest Dental Products, LLC.
What is the FDA product code for Harvest Dental HD Gum Strip?
The FDA product code for Harvest Dental HD Gum Strip 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.