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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 K232243
Device Name EVO 700 series high speed handpiece
Applicant
Ttbio Corp.
2f., #7, 6th Rd. Industry Park
Taichung,  CN 40755
Applicant Contact Sheng-Chieh Su
Correspondent
Ttbio Corp.
2f., #7, 6th Rd. Industry Park
Taichung,  CN 40755
Correspondent Contact Siow Woon Chyi
Regulation Number872.4200
Classification Product Code
EFB  
Date Received07/28/2023
Decision Date 08/23/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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