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FDA 510(k)

Harvest Dental Polymer Blocks

K-Number: K180578 · 2018-12-12

ApplicantHarvest Dental Products, LLC
Decision Date2018-12-12
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Harvest Dental Polymer Blocks 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 2018-12-12 under 510(k) number K180578. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Harvest Dental Polymer Blocks?

Harvest Dental Polymer Blocks is a medical device that received FDA 510(k) clearance on 2018-12-12. The listed applicant is Harvest Dental Products, LLC. The 510(k) number is K180578.

When did Harvest Dental Polymer Blocks receive FDA 510(k) clearance?

Harvest Dental Polymer Blocks received FDA 510(k) clearance on 2018-12-12, under 510(k) number K180578.

Who is the listed applicant for Harvest Dental Polymer Blocks?

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 Polymer Blocks?

The FDA product code for Harvest Dental Polymer Blocks is EBG.

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 OutK222489Harvest Printable Resin

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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