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510(k) K092412

STRONG IMPLANT HANDPIECES by Saeshin Precision Co., Ltd. — Product Code EFA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2009
Date Received
August 6, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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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