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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K140966
Device Name VONFLEX S BITE
Applicant
Vericom Co., Ltd.
48, Toegyegongdan 1-Gil
Chuncheon-Si, Gangwon - Do,  KR 200-944
Applicant Contact Myung-Hwan Oh
Correspondent
Vericom Co., Ltd.
2670 Walnut Ave.
Suite K
Tustin,  CA  92780
Correspondent Contact JAY HWANG
Regulation Number872.3660
Classification Product Code
ELW  
Date Received04/15/2014
Decision Date 08/15/2014
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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