FDA 510(k) Application Details - K172007

Device Classification Name Caries Detector, Laser Light, Transmission

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510(K) Number K172007
Device Name Caries Detector, Laser Light, Transmission
Applicant Duerr Dental AG
Hopfigheimer Strasse 17
Bietigheim-Bissingen D-74321 DE
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Contact Oliver Lange
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Regulation Number 872.1745

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Classification Product Code NTK
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Date Received 07/03/2017
Decision Date 11/22/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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