Osstell Beacon

Handpiece, Direct Drive, Ac-powered

Osstell AB

The following data is part of a premarket notification filed by Osstell Ab with the FDA for Osstell Beacon.

Pre-market Notification Details

Device IDK181888
510k NumberK181888
Device Name:Osstell Beacon
ClassificationHandpiece, Direct Drive, Ac-powered
Applicant Osstell AB Stampgaten 14 Gotenborg,  SE 41101
ContactStefan Horn
CorrespondentCherita James
M Squared Associates, Inc 575 8th Ave Suite 1212 New York,  NY  10018
Product CodeEKX  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-07-13
Decision Date2019-08-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
09010522000861 K181888 000
09010522002469 K181888 000
09010522002087 K181888 000
09010522002117 K181888 000
09010522002131 K181888 000
09010522002384 K181888 000
09010522002391 K181888 000
09010522002407 K181888 000
09010522002360 K181888 000
09010522002070 K181888 000

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