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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K190508
Device Name EVO 450 series High Speed Handpieces
Applicant
Ttbio Corp.
2f, #7, 6th Rd., Industry Park
Taichung,  TW 40755
Applicant Contact Sheng-Chieh Su
Correspondent
Ttbio Corp.
2f, #7, 6th Rd., Industry Park
Taichung,  TW 40755
Correspondent Contact Shu-Ching Lee
Regulation Number872.4200
Classification Product Code
EFB  
Date Received03/01/2019
Decision Date 12/11/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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