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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 K062389
Device Name Z-BLOCK, MODELS 20/19, 40/19, 55/19
Applicant
Foundation Milling Centre
2454 Mcmullen Booth Rd.
Suite 427
Clearwater,  FL  33759
Applicant Contact IAN P GORDON
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact DANIEL W LEHTONEN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received08/16/2006
Decision Date 08/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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