FDA 510(k) Application Details - K152576

Device Classification Name Implant, Endosseous, Root-Form

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510(K) Number K152576
Device Name Implant, Endosseous, Root-Form
Applicant Alliance Global Technology Co., Ltd.
2F., No.92, Luke 5th Rd.
Kaohsiung 82151 TW
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Contact YAYUAN CHANG
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Regulation Number 872.3640

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Classification Product Code DZE
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Date Received 09/09/2015
Decision Date 06/02/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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