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iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D) +8 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K250374

by Stryker Instruments

Identifiers

510(k) Number
K250374 FDA 510(k)
FDA Product Code
HBE FDA 510(k)
Models / Variants
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D) FDA 510(k)
iBur 3.0mm Precision Round, Distal Bend (8431-009-030) FDA 510(k)
iBur 4.0mm Precision Round, Distal Bend (8431-009-040) FDA 510(k)
iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D) FDA 510(k)
iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D) FDA 510(k)
iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D) FDA 510(k)
iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC) FDA 510(k)
iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC) FDA 510(k)
iBur 5.0mm Coarse Diamond R FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.4310 FDA 510(k)
Regulation Number
882.4310 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The iBur instruments are endodontic files designed for rotary canal preparation in dental procedures. These devices feature diamond-coated or precision-ground tips in varying diameters (2.0mm, 3.0mm, 4.0mm, and 5.0mm) and shapes, including round and match head configurations, all with a distal bend for enhanced access and control within root canals. Their abrasive coatings facilitate efficient removal of dentin and shaping of the canal space, aiding in the preparation for obturation or further endodontic treatment.

These instruments are supplied as single-use, sterile devices intended for use in dental clinics and endodontic offices. Each variant is identified by its specific diameter, coating type, and bend angle, ensuring compatibility with different clinical scenarios. The iBur instruments are classified under FDA 510(k) clearance with a Special review type, falling under the product code HBE and reviewed by the Neurology Advisory Committee. They are not intended for MRI use and must be stored in a clean, dry environment to maintain sterility and functionality.

Frequently asked questions

What are the iBur instruments used for in dental procedures?

The iBur instruments are designed specifically for rotary canal preparation during endodontic treatments. Their diamond-coated or precision-ground tips efficiently remove dentin and shape root canals, ensuring proper preparation for obturation or further endodontic work. The distal bend in each model improves access and control within curved canals, making them ideal for complex cases.

Are the iBur files single-use or reusable?

The iBur instruments are supplied as single-use, sterile devices. This design ensures patient safety by eliminating cross-contamination risks and maintains consistent performance for each procedure. Single-use also simplifies sterilization logistics in clinical settings.

What sizes and models are available for the iBur files?

The iBur series includes multiple diameters (2.0mm, 3.0mm, 4.0mm, and 5.0mm) and tip configurations: diamond-coated (match head, round, coarse diamond), and precision-ground (round). Each variant is further distinguished by a distal bend, allowing clinicians to select the optimal tool for specific canal shapes and treatment requirements.

How should iBur instruments be stored to maintain sterility?

To preserve sterility and functionality, iBur instruments must be stored in a clean, dry environment, away from direct light or moisture. Proper packaging should remain intact until use, and they should be kept in a designated sterile storage area to prevent contamination. Avoid exposure to extreme temperatures or humidity.

Can these files be used in MRI environments?

No, the iBur instruments are explicitly not intended for use in MRI environments. Their materials and design are not compatible with magnetic resonance imaging, so they should only be used in non-MRI settings to avoid potential interference or safety risks.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Stryker Instruments

Sources (1)

  • FDA 510(k) K250374 24 fields · synced Oct 1, 2026