Steri-Oss Tiodized Screw

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

510(k) Number

K964739 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Screw Extraction Device and Thread Cleaning Tap

  Class II

  FDA 510(k) K960979 Active Cleared 20 May 1996

• Steri-Oss Titanium Plama Spray Cylindrical Implant

  Class II

  FDA 510(k) K911592 Active Cleared 22 Jul 1993

• Steri-Oss Screw Style Cp Titanium Implant

  Class II

  FDA 510(k) K923695 Active Cleared 10 Dec 1993

• Combination Kit

  Class II

  FDA 510(k) K953331 Active Cleared 8 Sep 1995

• Steri-Oss Immediate Placement Implant

  Class II

  FDA 510(k) K952917 Active Cleared 16 Oct 1995

• Replace Cylindrical Implants

  Class II

  FDA 510(k) K980439 Active Cleared 16 Mar 1998

See all devices from Steri-Oss, Inc. →

• What is the Steri-Oss Tiodized Screw used for?

  The Steri-Oss Tiodized Screw is designed specifically for screw-retained attachment of prosthetic components in dental implant systems. It connects prosthetic elements to dental implants, providing a stable and secure fixation in oral and maxillofacial applications. Its tiodized surface enhances grip and stability, ensuring long-term reliability for patients undergoing dental restoration procedures.

• Is the Steri-Oss Tiodized Screw single-use or reusable?

  The Steri-Oss Tiodized Screw is supplied as a single-use device. This classification ensures sterility and safety in sterile surgical environments, reducing the risk of cross-contamination and maintaining compliance with dental implant protocols that prioritize aseptic handling.

• What makes the tiodized surface of this screw beneficial?

  The tiodized surface of the Steri-Oss Tiodized Screw is engineered to improve the screw’s friction and stability when securing prosthetic components. This surface treatment helps prevent loosening over time, which is critical for the longevity of dental implants and the success of prosthetic attachments in oral environments.

• How is the Steri-Oss Tiodized Screw regulated?

  The Steri-Oss Tiodized Screw is regulated under the FDA’s 510(k) clearance pathway and classified as a Class II medical device. It was granted substantial equivalence through a traditional review process by the Dental (DE) Advisory Committee in 1997, ensuring it meets established safety and performance standards for dental fixation devices.

• What should be considered when storing the Steri-Oss Tiodized Screw?

  Since the Steri-Oss Tiodized Screw is a single-use device, it should be stored in a clean, dry environment protected from contamination. Proper packaging and adherence to manufacturer guidelines will help preserve its sterility until use in a sterile surgical setting, ensuring optimal performance and patient safety.