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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Harvest Dental Products, LLC. It received FDA 510(k) clearance on 2023-08-16 under 510(k) 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. The listed applicant is Harvest Dental Products, LLC. The 510(k) number is K231389.

When did Harvest Dental HD Gum Strip receive FDA 510(k) clearance?

Harvest Dental HD Gum Strip received FDA 510(k) clearance on 2023-08-16, under 510(k) number K231389.

Who is the listed applicant for Harvest Dental HD Gum Strip?

The FDA 510(k) record lists Harvest Dental Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Harvest Dental HD Gum Strip?

The FDA product code for Harvest Dental HD Gum Strip is EBI.

Other records listing Harvest Dental Products, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222961Harvest Conceal ZR Block OutK222489Harvest Printable ResinK180578Harvest Dental Polymer Blocks

Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

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.

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