XIVE TG Dental Implant System

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

510(k) Number

K032284 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• 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

• Ankylos Dental Implant System

  Class II

  FDA 510(k) K040946 Active Cleared 1 Jul 2004

See all devices from Friadent GmbH →

• What is the XIVE TG Dental Implant System designed for?

  The XIVE TG Dental Implant System is specifically designed for osseointegration in the jawbone, providing a stable foundation for dental restorations. Its tapered body with reverse buttress threads and flared head with grooves enhance primary stability and bone integration, making it suitable for single-tooth or multi-tooth replacement procedures in dental practices.

• How is the XIVE TG system supplied, and what are its key features?

  The system is supplied as a reusable surgical implant kit, intended for use under sterile conditions in dental offices. Key features include an external square-shaped connection for secure abutment attachment, a tapered implant body with reverse threads for improved stability, and a dome-shaped apex with grooves to promote bone growth and integration.

• Is the XIVE TG system single-use or reusable, and how should it be stored?

  The XIVE TG system is designed for single-patient use per manufacturer specifications, though the kit itself is reusable across multiple procedures. Storage must follow standard aseptic protocols for implantable medical devices to maintain sterility, as it is intended for surgical use in controlled environments.

• What diameters and lengths are available for the XIVE TG implants?

  The XIVE TG system is available in three diameters and five lengths, allowing clinicians to select the appropriate size for individual patient anatomy and treatment requirements. The specific dimensions are detailed in the accompanying surgical kit documentation.

• What regulatory clearance does the XIVE TG system hold, and how is it classified?

  The XIVE TG Dental Implant System holds FDA 510(k) clearance under product code DZE, classified as a dental device. It was reviewed under the Special review pathway by the Dental (DE) Advisory Committee and is considered substantially equivalent to predicate devices, as noted in the clearance documentation.