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FDA 510(k) Applications Submitted by Katja Simon
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230333
02/07/2023
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
Kettenbach GmbH & Co. KG
K191523
06/10/2019
Visalys Restorative Primer
Kettenbach GmbH & Co. KG
K191524
06/10/2019
Visalys Tooth Primer
Kettenbach GmbH & Co. KG
K191527
06/10/2019
Visalys CemCore, Visalys Cem Core Try In Paste
Kettenbach GmbH & Co. KG
K143104
10/29/2014
Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X
KETTENBACH GMBH & CO KG
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