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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Denture, Plastic, Teeth
510(k) Number K926070
Device Name PRIMODENT ACRYLIC TEETH
Applicant
I.T.C. Ent.
2215 Chimney Springs Dr.
Marietta,  GA  30062
Applicant Contact PETER PETRIC
Correspondent
I.T.C. Ent.
2215 Chimney Springs Dr.
Marietta,  GA  30062
Correspondent Contact PETER PETRIC
Regulation Number872.3590
Classification Product Code
ELM  
Date Received12/01/1992
Decision Date 02/17/1994
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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