FRIALIT-2 Select Components

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

510(k) Number

K993095 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• XIVE TG Dental Implant System

  Class II

  FDA 510(k) K032284 Active Cleared 14 Aug 2003

• Frialoc Dental Implant System

  Class II

  FDA 510(k) K013067 Active Cleared 9 Apr 2002

• Frios Algipore

  Class II

  FDA 510(k) K023799 Active Cleared 5 Feb 2003

• Modification to Frialit-2 Dental Implant System

  Class II

  FDA 510(k) K031674 Active Cleared 14 Aug 2003

• Xive Dental Implant System Multiple

  Class II

  FDA 510(k) K032158 Active Cleared 14 Aug 2003

• Frialit-2 Bone Profiler

  Class II

  FDA 510(k) K993560 Active Cleared 10 Jan 2000

See all devices from Friadent GmbH →

• What is the Frialit-2 Select Components used for?

  The Frialit-2 Select Components is used in dental applications, indicating its purpose is to support dental procedures and treatments.

• How is the Frialit-2 Select Components supplied?

  The device is supplied by Friadent GmbH, a manufacturer of dental devices, ensuring a consistent and reliable source.

• What is the regulatory status of the Frialit-2 Select Components?

  The device has received FDA 510K authorization, indicating it has been reviewed and cleared for use in dental applications.

• What is the product code for the Frialit-2 Select Components?

  The device is classified under the product code DZE, which categorizes it within a specific group of dental devices.