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TurboTemp EZ

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191619

by Zest Anchors, LLC

Identifiers

510(k) Number
K191619 FDA 510(k)
FDA Product Code
EBG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3770 FDA 510(k)
Regulation Number
872.3770 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

TurboTemp EZ is a self-cure provisional crown and bridge composite, classified as a dental restorative material. It is designed to provide durable and aesthetically pleasing temporary restorations for both short- and long-term use in dental applications. The material is formulated with a high filler content to enhance mechanical properties, ensuring reliability during provisional restoration procedures.

This composite is supplied as a self-curing system, intended for use in dental offices by trained professionals. It is not sterile at the point of sale but is intended for single-use per application. The device is regulated under FDA 510(k) clearance (K191619) and falls under the Dental advisory committee classification. No specific MRI safety or sterility requirements beyond standard dental practice protocols are noted in the data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TurboTemp EZ | Zest Dental Solutions, TurboTemp EZ | Zest Dental Solutions, PDF Sr. Regulatory Affairs Specialist 2875 Loker Avenue East Trade/Device ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zest Anchors, LLC

Sources (1)

  • FDA 510(k) K191619 24 fields · synced Sep 20, 2026