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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powder, Porcelain
510(k) Number K100145
Device Name A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06
Applicant
A&E Bioceramic Co., Ltd.
# 10, Ln. 273, Sec. 4
Changing Rd., Luzhu Towhship
Taoyuan County,  TW 338
Applicant Contact MARZ CHIU
Correspondent
A&E Bioceramic Co., Ltd.
# 10, Ln. 273, Sec. 4
Changing Rd., Luzhu Towhship
Taoyuan County,  TW 338
Correspondent Contact MARZ CHIU
Regulation Number872.6660
Classification Product Code
EIH  
Date Received01/19/2010
Decision Date 04/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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