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BEGO Semados RS/RSX Implant System

by BEGO Implant Systems GmbH & Co. KG

510(k) K201700

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 NumberK201700 Date13 Jan 2021ClearedStatusActive

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  • Withdrawn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, 21 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 Bego Semados Rs/Rsx Implant System is a dental implant system made of commercially pure titanium (Grade 4). It is a self-tapping, conical implant available with either a machined shoulder (Rs/Rs Pro) or microstructured shoulder (Rsx/Rsx Pro) and platform switching. The system includes individual CAD/CAM-fabricated prosthetic components and surgical guides. The implants are designed for various indications in implant dentistry.

The Bego Semados Rs/Rsx Implant System is supplied in different configurations, including Rs and Rsx implants with varying shoulder types. The system has received FDA 510K authorization. The implants are intended for use in dental applications, with the specific use depending on the clinician's preference and patient treatment requirements. The system is designed to provide a range of options for dental implant procedures.

From the manufacturer

BEGO Semados ® RS/RSX or RS/RSX Pro implants are individual and are available with machined shoulder (RS/RS Pro) or microstructured shoulder (RSX/RSX Pro) and platform switching, depending on the clinician's preference and the requirements of the patient treatment. The range is supplemented by individual CAD / CAM-fabricated prosthetic components and surgical guides.

Source: bego.com

The BEGO Semados ® RS/RSX implant is a self-tapping, conical implant made of commercially pure titanium (Grade 4). In contrast to the RSX implant, the RS implant has a 0.5 mm machined cervical area.

Source: eshop.bego.com

Other devices from BEGO Implant Systems GmbH & Co. KG

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Questions

AI-generated answers, 21 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 BEGO Semados RS/RSX Implant System made of?

    The BEGO Semados RS/RSX Implant System is made of commercially pure titanium (Grade 4).

  • What are the different configurations of the BEGO Semados RS/RSX Implant System?

    The system is supplied in different configurations, including Rs and Rsx implants with varying shoulder types, such as machined or microstructured shoulders.

  • What is the intended use of the BEGO Semados RS/RSX Implant System?

    The implants are intended for use in dental applications, with the specific use depending on the clinician's preference and patient treatment requirements.

  • Has the BEGO Semados RS/RSX Implant System received any authorizations?

    Yes, the system has received FDA 510K authorization, indicating that it is substantially equivalent to a predicate device.