Microhybrid 12

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

510(k) Number

K022974 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• Microfill 13

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• What is the Microhybrid 12 used for in dental applications?

  Microhybrid 12 is a tooth shade resin material designed for shade matching in restorative dentistry. It helps dentists select the appropriate color for dental restorations to achieve natural-looking results.

• How is the Microhybrid 12 supplied and what is its regulatory status?

  The Microhybrid 12 is supplied by Ab Ardent and received FDA clearance as substantially equivalent under product code EBF. It is regulated under 21 CFR 872.3690 and was cleared on November 22, 2002.

• Is the Microhybrid 12 a single-use or reusable dental material?

  The device data does not specify whether Microhybrid 12 is single-use or reusable. As a shade matching material, it may be used multiple times for different patients or procedures, but specific usage instructions would be provided by the manufacturer.

• What sizes or models of Microhybrid 12 are available?

  The device data does not specify different sizes or models of Microhybrid 12. It appears to be a single product configuration for shade matching purposes in restorative dentistry.