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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cement, dental
510(k) Number K003658
Device Name TEMP-BOND NE 2
Applicant
SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE,  CA  92867
Applicant Contact COLLEEN BOSWELL
Correspondent
SYBRON DENTAL SPECIALTIES, INC.
1717 WEST COLLINS AVE.
ORANGE,  CA  92867
Correspondent Contact COLLEEN BOSWELL
Regulation Number872.3275
Classification Product Code
EMA  
Date Received11/28/2000
Decision Date 01/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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