FDA 510(k) Application Details - K070307

Device Classification Name Scaler, Ultrasonic

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510(K) Number K070307
Device Name Scaler, Ultrasonic
Applicant DENTSPLY INTERNATIONAL, INC.
221 W. PHILADELPHIA ST., SE 60
SUSQUEHANNA COMMERCE CTR.
YORK, PA 17404 US
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Contact HELEN LEWIS
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Regulation Number 872.4850

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Classification Product Code ELC
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Date Received 02/01/2007
Decision Date 05/02/2007
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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