FDA 510(k) Application Details - K090476

Device Classification Name Implant, Endosseous, Orthodontic

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510(K) Number K090476
Device Name Implant, Endosseous, Orthodontic
Applicant SYNTEC SCIENTIFIC CORP.
3F1. 96 CHUNG HSIAO E. RD.
SEC. 3
TAIPEI 106 TW
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Contact SUSAN CHENG
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Regulation Number 872.3640

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Classification Product Code OAT
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Date Received 02/24/2009
Decision Date 06/18/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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