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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name alloy, gold-based noble metal
510(k) Number K920244
Device Name DW240 #73C ALLOY FOR PORCELAIN FUSED TO METAL
Applicant
IVOCLAR NORTH AMERICA, INC.
175 pineview dr.
amherst,  NY  14228
Applicant Contact lloyd v ziemendorf
Correspondent
IVOCLAR NORTH AMERICA, INC.
175 pineview dr.
amherst,  NY  14228
Correspondent Contact lloyd v ziemendorf
Regulation Number872.3060
Classification Product Code
EJT  
Date Received01/17/1992
Decision Date 03/26/1992
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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