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FDA 510(k)

BEGO Semados® RS/RSX Implant System

K-Number: K201700 · 2021-01-13

ApplicantBego Implant Systems GmbH & Co. KG
Decision Date2021-01-13
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BEGO Semados® RS/RSX Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Bego Implant Systems GmbH & Co. KG. It received FDA 510(k) clearance on 2021-01-13 under 510(k) number K201700. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BEGO Semados® RS/RSX Implant System?

BEGO Semados® RS/RSX Implant System is a medical device that received FDA 510(k) clearance on 2021-01-13. The listed applicant is Bego Implant Systems GmbH & Co. KG. The 510(k) number is K201700.

When did BEGO Semados® RS/RSX Implant System receive FDA 510(k) clearance?

BEGO Semados® RS/RSX Implant System received FDA 510(k) clearance on 2021-01-13, under 510(k) number K201700.

Who is the listed applicant for BEGO Semados® RS/RSX Implant System?

The FDA 510(k) record lists Bego Implant Systems GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BEGO Semados® RS/RSX Implant System?

The FDA product code for BEGO Semados® RS/RSX Implant System is DZE.

Other records listing Bego Implant Systems GmbH & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201412BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit

Related Devices (Code: DZE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic ABK252031Adin Long Dental Implant SystemAdin Dental Implant Systems , Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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