ITI Dental Implant System

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

510(k) Number

K030007 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Synocta Abutments

  Class II

  FDA 510(k) K073628 Active Cleared 22 Jan 2008

• Straumann Dental Implant System

  Class II

  FDA 510(k) K130222 Active Cleared 29 Apr 2013

• Tl 04.1mm Rn, S, Slactive Tizr 6, 8, 10, 12, 14, 16mm Dental Implants

  Class II

  FDA 510(k) K122855 Active Cleared 12 Dec 2012

• Straumann Screw-Retained Abutment

  Class II

  FDA 510(k) K150814 Active Cleared 10 Aug 2015

• Straumann 4 mm Short Implants

  Class II

  FDA 510(k) K202942 Active Cleared 8 Feb 2021

• Straumann Cares Screw-Retained Bridge Titanium, Straumann Cares Dolder Bar Titanium

  Class II

  FDA 510(k) K112280 Active Cleared 16 Nov 2011

See all devices from Straumann USA →

• What is the ITI Dental Implant System used for?

  The ITI Dental Implant System is designed to replace missing teeth through osseointegration, which is the direct structural and functional connection between living bone and the implant’s surface. This process provides a stable foundation for prosthetic teeth, restoring both function and aesthetics in patients with partial or complete tooth loss. It is specifically intended for use in oral and maxillofacial surgery to support long-term dental restoration.

• How is the ITI Dental Implant System supplied and what are its sterility and reuse conditions?

  The ITI Dental Implant System is supplied as a sterile, single-use device. This ensures safety and reliability during surgical placement by qualified dental professionals. Due to its sterile packaging and single-use nature, the system is not intended for reuse, as reuse could compromise sterility and compromise patient safety.

• What sizes and configurations are available for the ITI Dental Implant System?

  The ITI Dental Implant System is available in various sizes and configurations to accommodate different anatomical requirements. These variations allow for customization based on patient-specific needs, ensuring optimal fit and integration with the patient’s bone structure. The exact range of sizes can be referenced in the product documentation provided by Straumann USA.

• How should the ITI Dental Implant System be stored to maintain sterility?

  To preserve sterility, the ITI Dental Implant System must be stored according to the manufacturer’s instructions. Typically, this involves keeping the sterile packaging intact and sealed until the time of use. Storage should be in a clean, dry environment, away from direct sunlight or extreme temperatures, to prevent contamination or degradation of the implant’s integrity.

• What regulatory pathway does the ITI Dental Implant System follow?

  The ITI Dental Implant System is regulated under the FDA’s 510(k) clearance process, specifically classified under Product Code DZE for dental implants. It has been determined to be Substantially Equivalent to predicate devices through a Traditional review pathway by the FDA’s Dental (DE) Advisory Committee. This clearance ensures the device meets established safety and effectiveness standards for dental implants.