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Straumann GBR System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K011698

by Institut Straumann AG

Identifiers

510(k) Number
K011698 FDA 510(k)
FDA Product Code
JEY FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.4760 FDA 510(k)
Regulation Number
872.4760 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Straumann GBR System is a bone plate device used in dental procedures. It is designed to provide structural support and stabilization during guided bone regeneration.

This device is authorized under FDA 510(k) clearance. It is intended for professional use within a dental clinical setting.

Frequently asked questions

What is the primary purpose of the Straumann GBR System?

The Straumann GBR System is a bone plate device intended to provide structural support and stabilization to the surgical site during guided bone regeneration procedures.

Who is authorized to use this device?

This device is intended for professional use only and must be utilized within a dental clinical setting by qualified practitioners.

What is the regulatory status of this device?

The Straumann GBR System is authorized under FDA 510(k) clearance, which indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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. Sources consulted: Welcome to Straumann, Straumann Group Login

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Institut Straumann AG

Sources (1)

  • FDA 510(k) K011698 24 fields · synced Sep 23, 2026