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ITI Dental Implant System

by Straumann USA 5 variants

510(k) K031055

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031055 Date7 Jul 2003ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The ITI Dental Implant System is a dental implant device used for replacing missing teeth. It provides a foundation for fixed or removable replacement teeth that are made to match your natural teeth.

The system is supplied by Straumann USA and is authorized under FDA 510K clearance. It is available in various models and sizes, with specific details to be confirmed with the manufacturer regarding sterility, single-use or reusable status, MRI safety, and storage requirements.

Other devices from Straumann USA

See all devices from Straumann USA →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the ITI Dental Implant System used for?

    The ITI Dental Implant System is a dental implant device used for replacing missing teeth. It provides a foundation for fixed or removable replacement teeth that are made to match natural teeth.

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

    The system is available in various models and sizes, but specific details regarding sterility, single-use or reusable status, MRI safety, and storage requirements should be confirmed with the manufacturer.

  • What is the regulatory status of the ITI Dental Implant System?

    The ITI Dental Implant System is authorized under FDA 510K clearance, which means it has been determined to be substantially equivalent to other legally marketed devices.

  • Who manufactures the ITI Dental Implant System?

    The ITI Dental Implant System is manufactured by Straumann USA, located at Reservoir Pl., 1601 Trapelo Rd., Waltham, MA 02154.