Cuttersil Comfort

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K965163 ↗

FDA Product Code

ELW

Device Class

Class II

Regulation

21 CFR Part 872.3660

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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  Class II

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• Ames Dca 2000TM Analyzer and Reagent System

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  Class I

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• Flexitime Xtreme

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• Venus Diamond Flow

  Class II

  FDA 510(k) K091635 Active Cleared 3 Sep 2009

See all devices from Heraeus Kulzer, Inc. →