MRI Compatibility for Straumann Dental Implant Systems

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

Full name

MRI Compatibility for Existing Straumann Dental Implant Systems

510(k) Number

K190662 ↗

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 types of existing Straumann dental implants can be modified to achieve MRI compatibility with this update?

  This modification applies to existing Straumann dental implant systems that include implants, abutments, copings, healing caps, and closure screws. The update ensures these components are MRI Conditional, meaning they can be safely scanned under specific MRI conditions without altering the original implant design. It’s designed to work with the full range of Straumann systems already in use by dentists and oral surgeons.

• How does this MRI compatibility modification differ from the original Straumann implants, and what does that mean for patients?

  The modification does not change the original implant’s osseointegration function or physical design—it only adds MRI Conditional status. This means patients with these implants can now undergo MRI scans under defined scanning parameters (e.g., field strength, sequence type) without risking damage to the implant or interference with imaging. The update is purely about safety during MRI procedures, not clinical performance.

• Are the modified components single-use or reusable, and how should they be handled before an MRI?

  The modified components (abutments, copings, healing caps, and closure screws) are intended for reuse within a patient’s treatment plan, as they are part of the existing Straumann system. Before an MRI, ensure these components are clean and dry, as moisture or debris could affect imaging quality. The implants themselves remain in place, and the modification ensures they won’t be damaged by MRI fields under the specified conditions.

• What MRI systems and scanning parameters are compatible with these modified Straumann implants?

  The modification has been evaluated through MRI simulations to confirm MR Conditional status, but the exact compatible systems and parameters (e.g., field strength, sequences) are detailed in the provided labeling or technical documentation. Clinicians should consult the manufacturer’s instructions for the specific MRI settings and restrictions to ensure safe scanning. This ensures imaging safety without compromising the implant’s function.

• How do I obtain this MRI compatibility update for my existing Straumann implants, and what documentation supports its regulatory status?

  This update is supplied as a modification kit for existing Straumann systems, available through Straumann USA, LLC. The regulatory status is supported by an FDA 510(k) clearance (K190662), confirming it is substantially equivalent to legally marketed devices. For details on ordering or technical specifications, contact Loretta Kushner-Mooney at Straumann USA, LLC, or refer to the provided clearance documentation. Always follow the manufacturer’s instructions for proper application.