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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K003377
Device Name FERMIT N PLUS
Applicant
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact ANDY GULATI
Correspondent
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact ANDY GULATI
Regulation Number872.3770
Classification Product Code
EBG  
Date Received10/30/2000
Decision Date 12/04/2000
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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