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

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

BEGO Implant Systems GmbH & Co. KG

The following data is part of a premarket notification filed by Bego Implant Systems Gmbh & Co. Kg with the FDA for 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.

Pre-market Notification Details

Device IDK201412
510k NumberK201412
Device Name: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
ClassificationSterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Str. 1 Bremen,  DE 28359
ContactBertrand Lecointe
CorrespondentBertrand Lecointe
BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Str. 1 Bremen,  DE 28359
Product CodeKCT  
CFR Regulation Number880.6850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-28
Decision Date2021-02-18

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