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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K922942
Device Name PRO-SCOPE MODEL # PS-4000
Applicant
Pro-Den Systems, Inc.
3347 N. Lombard St.
Portland,  OR  97217
Applicant Contact CADE ADAMS
Correspondent
Pro-Den Systems, Inc.
3347 N. Lombard St.
Portland,  OR  97217
Correspondent Contact CADE ADAMS
Regulation Number872.6640
Classification Product Code
EIA  
Date Received06/18/1992
Decision Date 09/10/1993
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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