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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 K130654
Device Name CRYSTAL ULTRA
Applicant
Dental Laboratory Milling Supplies, LLC (Dlms)
14201 N 87th St. #A101
Scottsdale,  AZ  85260
Applicant Contact SCOTT ATKIN
Correspondent
Dental Laboratory Milling Supplies, LLC (Dlms)
14201 N 87th St. #A101
Scottsdale,  AZ  85260
Correspondent Contact SCOTT ATKIN
Regulation Number872.6660
Classification Product Code
EIH  
Subsequent Product Code
EBF  
Date Received03/12/2013
Decision Date 09/24/2013
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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