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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 K072569
Device Name METOXIT CAM-BLANKS
Applicant
Metoxit AG
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Applicant Contact IAN GORDON
Correspondent
Metoxit AG
1705 S. Capital Of Texas Hwy.,
Suite 500
Austin,  TX  78746
Correspondent Contact IAN GORDON
Regulation Number872.6660
Classification Product Code
EIH  
Date Received09/12/2007
Decision Date 10/31/2007
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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