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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 K041098
Device Name COOL TEMP NATURAL
Applicant
Coltene AG
1349 Lexington Ave.
New York,  NY  10128
Applicant Contact H.J. VOGELSTEIN
Correspondent
Coltene AG
1349 Lexington Ave.
New York,  NY  10128
Correspondent Contact H.J. VOGELSTEIN
Regulation Number872.3770
Classification Product Code
EBG  
Date Received04/27/2004
Decision Date 05/13/2004
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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