BEGO SEMADOS Tr 58350 +4 more— 510(k) K201412

Name: FDA 510(k) clearance K201412
Creator: U.S. Food and Drug Administration
Published: 2021-02-18

Substantially Equivalent

Bego Implant Systems GmbH & Co. KG

FDA 510(k) clearance K201412 for BEGO SEMADOS Tr 58350 +4 more, Substantially Equivalent on 2021-02-18. Applicant: Bego Implant Systems GmbH & Co. KG. Device class: 2.

Clearance details

Device name as filed: BEGO 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
Applicant: Bego Implant Systems GmbH & Co. KG
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2020-05-28
Decision date: 2021-02-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bremen, DE

Download summary PDF View on FDA.gov ↗

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