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510(k) K080677

COMFORTRONIC 4894 AND COMFORTDRIVE 200XDA HANDPIECE by Kaltenbach & Voigt GmbH & Co. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2008
Date Received
March 10, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type

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