ITI Transversal Screwing System

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

510(k) Number

K943720 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Iti Distance System

  Class II

  FDA 510(k) K931993 Active Cleared 26 Apr 1994

• Pre-Sterilized Iti Dental Implants

  Class II

  FDA 510(k) K920928 Active Cleared 15 Jul 1992

• Memfix

  Class II

  FDA 510(k) K955369 Active Cleared 23 Jan 1996

• Plastic Protection Healing Caps

  Class II

  FDA 510(k) K962023 Active Cleared 15 Aug 1996

• Endosseous Dental Implant & Accessories

  Class II

  FDA 510(k) K955281 Active Cleared 15 Mar 1996

• Iti Angled Abutment

  Class II

  FDA 510(k) K941393 Active Cleared 14 Jun 1995

See all devices from The Straumann Company →

• What is the ITI Transversal Screwing System used for in dental procedures?

  The ITI Transversal Screwing System is specifically designed for placing transversal screws in bone during oral and maxillofacial surgery. It helps secure fixation for dental implants, ensuring stability for abutments or prosthetic restorations within the jawbone. This is particularly useful in scenarios requiring strong, reliable anchorage for dental reconstruction.

• Is the ITI Transversal Screwing System intended for single-use or reusable applications?

  The ITI Transversal Screwing System is supplied as a reusable surgical instrument set, meaning it is meant to be sterilized and used repeatedly in sterile operating environments by dental professionals. There are no indications in the provided data that it is intended for single-use.

• How was the regulatory approval for the ITI Transversal Screwing System determined?

  The ITI Transversal Screwing System received FDA 510(k) clearance in 1995 under the traditional review process. It was deemed substantially equivalent to a predicate device, meaning the FDA determined it had the same intended use and technological characteristics as a previously approved device, ensuring it met applicable safety and effectiveness requirements.

• What type of environment is the ITI Transversal Screwing System intended for use in?

  The system is explicitly designed for use in sterile operating environments, as it is a reusable surgical instrument set meant for dental professionals performing oral and maxillofacial procedures. Proper sterilization protocols must be followed to maintain safety and efficacy.