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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 K091852
Device Name BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205
Applicant
Refractron Technologies Corp.
7736 Woodside Ct.
Maineville,  OH  45039
Applicant Contact JOHN GAGLIARDI
Correspondent
Refractron Technologies Corp.
7736 Woodside Ct.
Maineville,  OH  45039
Correspondent Contact JOHN GAGLIARDI
Regulation Number872.6660
Classification Product Code
EIH  
Date Received06/23/2009
Decision Date 09/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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