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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K993514
Device Name DEFINITE
Applicant
Degussa - Ney Dental, Inc.
65 W. Dudly Town Rd.
Bloomfield,  CT  06002
Applicant Contact THOMAS B CAMERON
Correspondent
Degussa - Ney Dental, Inc.
65 W. Dudly Town Rd.
Bloomfield,  CT  06002
Correspondent Contact THOMAS B CAMERON
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/18/1999
Decision Date 02/24/2000
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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