Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Zest Anchors, LLC. It received FDA 510(k) clearance on 2019-09-11 under approval 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. It is manufactured by Zest Anchors, LLC. The 510(k) number is K191619.

When was TurboTemp EZ approved by the FDA?

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

What company makes TurboTemp EZ?

TurboTemp EZ is manufactured by Zest Anchors, LLC.

What is the FDA product code for TurboTemp EZ?

The FDA product code for TurboTemp EZ is EBG.

Other Devices by Zest Anchors, LLC

K151789LOCATOR F-Tx Attachment System K220252High Retention Attachment System K213391High Retention Attachment System K233587LOCATOR Angled Abutment (Various) K252944LOCATOR® Angled Abutment K250721LOCATOR® Angled Abutment

View all 9 devices →

Related Devices (Code: EBG)

K153490DD medical polymersDental Direkt GmbH K152443Vericore Gradient Temporary DiscWhip Mix Corporation K153753TelioCAD MultiIvoclar Vivadent, Inc. K152215DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLORDentalplus GmbH K171729Fixtemp C&BDreve Dentamid GmbH K172281PuRE PMMA DiscQuest Dental USA Corp.

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.

↑