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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Rotary
510(k) Number K170596
Device Name TN-Brush
Applicant
Genoss Co., Ltd.
1f, Gyeonggi R&Db Center, 105 Gwanggyo-Ro,
Yeongton-Gu, Suwon-Si
Suwon-Si,  KR 443-270
Applicant Contact Hyeyoung Moon
Correspondent
Genoss Co., Ltd.
1f, Gyeonggi R&Db Center, 105 Gwanggyo-Ro,
Yeongton-Gu, Suwon-Si
Suwon-Si,  KR 443-270
Correspondent Contact Hyeyoung Moon
Regulation Number872.4840
Classification Product Code
ELB  
Date Received02/28/2017
Decision Date 09/11/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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