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510(k) K141183

EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES by Ttbio Corp. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2015
Date Received
May 7, 2014
Clearance Type
Abbreviated
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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