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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K051243
Device Name JET BLUE BITE
Applicant
Coltene/Whaledent AG
1349 Lexington Ave.
New York,  NY  10128
Applicant Contact HENRY J VOGELSTEIN
Correspondent
Coltene/Whaledent AG
1349 Lexington Ave.
New York,  NY  10128
Correspondent Contact HENRY J VOGELSTEIN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received05/13/2005
Decision Date 06/23/2005
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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