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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Paper, Articulation
510(k) Number K864572
Device Name FIXTECTOR
Applicant
Prodent Intl., Inc.
111 N. Alfred St.
P.O. Box 299
Alexandria,  VA  22313
Applicant Contact STEPHEN A BENT
Correspondent
Prodent Intl., Inc.
111 N. Alfred St.
P.O. Box 299
Alexandria,  VA  22313
Correspondent Contact STEPHEN A BENT
Regulation Number872.6140
Classification Product Code
EFH  
Date Received11/20/1986
Decision Date 02/12/1987
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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