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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, root-form
510(k) Number K111189
Device Name SYNTEC DENTAL IMPLANT
Original Applicant
SYNTEC SCIENTIFIC CORP.
3f1. 96 chung hsiao e. rd.
sec. 3
taipei city,  TW 106
Original Contact chia-ching lee
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received04/28/2011
Decision Date 12/20/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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