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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K920561
Device Name DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET.
Applicant
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact LLOYD ZIEMENDORF
Correspondent
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact LLOYD ZIEMENDORF
Regulation Number872.3710
Classification Product Code
EJH  
Date Received02/06/1992
Decision Date 03/02/1992
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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