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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Periodontic
510(k) Number K931330
Device Name DENTAL INSTRUMENTS SCALER
Applicant
Minnesota Prophy Power, Inc.
11538 172nd St.
Lakeville,  MN  55044
Applicant Contact ROSELYN R WILSON
Correspondent
Minnesota Prophy Power, Inc.
11538 172nd St.
Lakeville,  MN  55044
Correspondent Contact ROSELYN R WILSON
Regulation Number872.4565
Classification Product Code
EMN  
Date Received03/16/1993
Decision Date 01/26/1994
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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