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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K131468
Device Name DENRACLE DENTAL ABUTMENT
Applicant
GREEN DENTECH CO LTD
2F, 17, DEYUANPI BLVD.
DANUNG LI., LIOUYING DIST.
TAINAN CITY,  TW 73659
Applicant Contact SUE RU
Correspondent
GREEN DENTECH CO LTD
2F, 17, DEYUANPI BLVD.
DANUNG LI., LIOUYING DIST.
TAINAN CITY,  TW 73659
Correspondent Contact SUE RU
Regulation Number872.3630
Classification Product Code
NHA  
Date Received05/21/2013
Decision Date 05/06/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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