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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 K001418
Device Name ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S
Applicant
Procera Sandvik, Inc.
1872 Mcbride Ave.
Fair Lawn,  NJ  07410
Applicant Contact MARTIN STERNER
Correspondent
Procera Sandvik, Inc.
1872 Mcbride Ave.
Fair Lawn,  NJ  07410
Correspondent Contact MARTIN STERNER
Regulation Number872.6660
Classification Product Code
EIH  
Date Received05/05/2000
Decision Date 07/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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