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CEREC SpeedGlaze

by SIRONA Dental Systems GmbH

510(k) K160099

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160099 Date2 Jun 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EIH
Device class
Class II
Regulation
21 CFR Part 872.6660
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

CEREC SpeedGlaze is a spray used for glazing fully-anatomical restorations. It applies a layer of glass powder to the sprayed surface, which is melted on in the subsequent firing phase.

It is used for coating dental restorations made from Sirona CAD/CAM materials. The device is supplied as a 75ml spray and is intended for use in dental chairside settings.

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Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is CEREC SpeedGlaze used for?

    CEREC SpeedGlaze is used to apply a layer of glass powder to fully-anatomical dental restorations made from Sirona CAD/CAM materials. This layer is melted during the subsequent firing phase to create a glazed surface, which enhances the restoration's aesthetics and durability.

  • How is CEREC SpeedGlaze supplied and what is its volume?

    CEREC SpeedGlaze is supplied as a 75ml spray container. This format allows for easy and controlled application of the glass powder onto dental restorations in a dental chairside setting, ensuring consistent coverage during the glazing process.

  • Is CEREC SpeedGlaze intended for single-use or reuse?

    CEREC SpeedGlaze is intended for single-use per application. As a spray device designed for chairside dental use, it is not meant to be reused after application to avoid contamination and ensure consistent performance, particularly given its role in preparing restorations for firing.

  • Where is CEREC SpeedGlaze intended to be used?

    CEREC SpeedGlaze is intended for use in dental chairside settings. This means it is designed to be used directly in the dental office during the restoration process, allowing clinicians to glaze restorations immediately after milling and before firing, without needing to send them to a laboratory.