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510(k) K101172

RDT3 HANDPIECE HEAD MODEL RDT3 by Redent Nova, Ltd. — Product Code EFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2010
Date Received
April 26, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Belt And/Or Gear Driven, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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