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FDA 510(k)

Harvest Printable Resin

K-Number: K222489 · 2023-05-12

ApplicantHarvest Dental Products, LLC
Decision Date2023-05-12
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Harvest Printable Resin 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 2023-05-12 under 510(k) 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. The listed applicant is Harvest Dental Products, LLC. The 510(k) number is K222489.

When did Harvest Printable Resin receive FDA 510(k) clearance?

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

Who is the listed applicant for Harvest Printable Resin?

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 Printable Resin?

The FDA product code for Harvest Printable Resin 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.

K231389Harvest Dental HD Gum StripK222961Harvest Conceal ZR Block OutK180578Harvest 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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