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510(k) K232243

EVO 700 series high speed handpiece by Ttbio Corp. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2023
Date Received
July 28, 2023
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

Other clearances by Ttbio Corp.

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  • K141183 — EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIE (February 27, 2015)
  • K132570 — ELECTRIC HANDPIECE SYSTEM (April 29, 2014)

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