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510(k) K031868

PROPHYPEARLS by Kavo America — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2003
Date Received
June 17, 2003
Clearance Type
Special
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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  • K024214 — KAVO EVEREST TITANBLANK (March 12, 2003)
  • K012308 — KAVO QUATTROCARE (June 26, 2002)

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