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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Other Noble Metal
510(k) Number K990078
Device Name D-SIGN IV (R&D PROJECT DW265#37)
Applicant
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact PETER P MANCUSO
Correspondent
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact PETER P MANCUSO
Regulation Number872.3060
Classification Product Code
EJS  
Date Received01/11/1999
Decision Date 02/12/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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