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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K983477
Device Name SUPER SEAL
Applicant
Phoenix Dental, Inc.
3452 W. Thompson Rd.
Fenton,  MI  48430
Applicant Contact ROBERT A CHERBA
Correspondent
Phoenix Dental, Inc.
3452 W. Thompson Rd.
Fenton,  MI  48430
Correspondent Contact ROBERT A CHERBA
Regulation Number872.3250
Classification Product Code
EJK  
Date Received10/02/1998
Decision Date 12/22/1998
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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