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510(k) K973876

PROPHYFLEX 2, MODEL 2012 by Kavo America — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1997
Date Received
October 10, 1997
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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