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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Prescription
510(k) Number K230237
Device Name Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
Applicant
Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.
3-3, # 10, Tiangui Rd., Mudong Town, Banan District
Chongqing,  CN 401338
Applicant Contact Chen Yang
Correspondent
Guangzhou GLOMED Biological Technology Co., Ltd.
2231, Bldg. 1, Rui Feng Center, Kaichuang Rd.,
Huangpu District
Guangzhou,  CN
Correspondent Contact Cassie Lee
Classification Product Code
MQC  
Subsequent Product Code
KMY  
Date Received01/30/2023
Decision Date 09/14/2023
Decision Substantially Equivalent (SESE)
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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