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FDA 510(k)

TurboTemp EZ

K-Number: K191619 · 2019-09-11

ApplicantZest Anchors, LLC
Decision Date2019-09-11
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TurboTemp EZ is the device name listed in this FDA 510(k) record. The listed applicant is Zest Anchors, LLC. It received FDA 510(k) clearance on 2019-09-11 under 510(k) number K191619. 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 TurboTemp EZ?

TurboTemp EZ is a medical device that received FDA 510(k) clearance on 2019-09-11. The listed applicant is Zest Anchors, LLC. The 510(k) number is K191619.

When did TurboTemp EZ receive FDA 510(k) clearance?

TurboTemp EZ received FDA 510(k) clearance on 2019-09-11, under 510(k) number K191619.

Who is the listed applicant for TurboTemp EZ?

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

What is the FDA product code for TurboTemp EZ?

The FDA product code for TurboTemp EZ is EBG.

Other records listing Zest Anchors, LLC as applicant

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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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