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510(k) K070869

PROPHY STAR 3 HYGIENE HANDPIECE, MODEL 264422 by Dentalez, Inc. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2007
Date Received
March 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Air-Powered, Dental
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

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