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510(k) K190508

EVO 450 series High Speed Handpieces by Ttbio Corp. — Product Code EFB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2019
Date Received
March 1, 2019
Clearance Type
Traditional
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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  • K132570 — ELECTRIC HANDPIECE SYSTEM (April 29, 2014)

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