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COLORISE

FDA 510(k)

Class II (US FDA 510(k))

510(k) K070677

by Zhermack S.P.A.

Identifiers

510(k) Number
K070677 FDA 510(k)
FDA Product Code
ELW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3660 FDA 510(k)
Regulation Number
872.3660 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

COLORISE is a Class II dental impression material classified under product code ELW and regulated under 872.3660. It is a chromatic color-change impression material that uses Chromatime technology to indicate working and setting times through a visible color transition. The device is used to take dental impressions for the fabrication of prostheses, crowns, and other oral structures.

The device is supplied as a single-use material and is intended for professional dental use in clinical settings. It is cleared through the Traditional 510(k) pathway with substantial equivalence determination. The manufacturer, Zhermack S.P.A., is based in Bend, Oregon, and the device was reviewed by the Dental advisory committee. Storage conditions and specific handling instructions are detailed in the manufacturer's labeling.

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: COLORISE by ZHERMACK S.P.A. | FDA 510 (k) Summary, K070677 FDA 510 (k) - COLORISE | Zhermack S.P.A., Zhermack S.P.A. FDA 510 (k) Products (1996-2009), Colorise, Zhermack, Prestige Dental Products

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zhermack S.P.A.

Sources (1)

  • FDA 510(k) K070677 24 fields · synced Sep 26, 2026