FDA 510(k) Application Details - K131468

Device Classification Name Abutment, Implant, Dental, Endosseous

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510(K) Number K131468
Device Name Abutment, Implant, Dental, Endosseous
Applicant GREEN DENTECH CO LTD
2F, 17, DEYUANPI BLVD.
DANUNG LI., LIOUYING DIST.
TAINAN CITY 73659 TW
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Contact SUE RU
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Regulation Number 872.3630

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Classification Product Code NHA
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Date Received 05/21/2013
Decision Date 05/06/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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