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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Articulators
510(k) Number K896131
Device Name GNATHOMAT ARTICULATOR
Applicant
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Applicant Contact L SEVERANCE,DDS
Correspondent
Ivoclar North America, Inc.
175 Pineview Dr.
Amherst,  NY  14228
Correspondent Contact L SEVERANCE,DDS
Regulation Number872.3150
Classification Product Code
EJP  
Date Received10/23/1989
Decision Date 12/04/1989
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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