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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 K912485
Device Name COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC
Applicant
Coltene/Whaledent, Inc.
236 Firth Ave.
New York,  NY  10001
Applicant Contact HENRY J VOGELSTEIN
Correspondent
Coltene/Whaledent, Inc.
236 Firth Ave.
New York,  NY  10001
Correspondent Contact HENRY J VOGELSTEIN
Regulation Number872.3660
Classification Product Code
ELW  
Date Received06/04/1991
Decision Date 07/25/1991
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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