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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Synthetic, Intraoral
510(k) Number K912724
Device Name GUIDOR(TM)
Applicant
Procordia Oratech AB
Novum
Blickagagen 6d, S-141 27
Huddinge, Sweden,  SE
Applicant Contact BJORN OLANDER
Correspondent
Procordia Oratech AB
Novum
Blickagagen 6d, S-141 27
Huddinge, Sweden,  SE
Correspondent Contact BJORN OLANDER
Regulation Number872.3930
Classification Product Code
NPK  
Date Received06/18/1991
Decision Date 05/13/1993
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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