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510(k) K971606

STERILE FLEXOFILE FILES AND INSTRUMENTS by Dentsply Intl. — Product Code EFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1997
Date Received
May 1, 1997
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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