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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pick, Massaging
510(k) Number K844238
Device Name ORAPIK PERIODONTAL SCALER
Applicant
Dental Concepts, LLC
25 W. 43rd. St.
New York,  NY  10036
Applicant Contact SETH NATTER
Correspondent
Dental Concepts, LLC
25 W. 43rd. St.
New York,  NY  10036
Correspondent Contact SETH NATTER
Regulation Number872.6650
Classification Product Code
JET  
Date Received11/01/1984
Decision Date 12/03/1984
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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