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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K130198
Device Name NEO DENTA ZIRCONIA
Applicant
Neo Group Limited
Rm. Q1d G/F, Kaiser Est 3rd Phase, 18 Man Lok St.
Hung Hom, Kowloon,  HK HK 852
Applicant Contact MIKE ADAMS
Correspondent
Neo Group Limited
Rm. Q1d G/F, Kaiser Est 3rd Phase, 18 Man Lok St.
Hung Hom, Kowloon,  HK HK 852
Correspondent Contact MIKE ADAMS
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/28/2013
Decision Date 10/21/2013
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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