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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K922988
Device Name ECO/DENTAL GENERAL DENTAL PACK
Applicant
Dyna-Pace Systems, Inc.
8735 Dunwoody Pl.
Suite 5
Atlanta,  GA  30350
Applicant Contact FREDRICK L AYCOCK
Correspondent
Dyna-Pace Systems, Inc.
8735 Dunwoody Pl.
Suite 5
Atlanta,  GA  30350
Correspondent Contact FREDRICK L AYCOCK
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received06/22/1992
Decision Date 11/04/1992
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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