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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K882135
Device Name AQUA DENT HANDPIECE EXTENSION AND AQUA DENT DISP.
Applicant
Vita Dental Co.
317 W. Water St.
Decorah,  IA  52101
Applicant Contact HARLAN L SATROM
Correspondent
Vita Dental Co.
317 W. Water St.
Decorah,  IA  52101
Correspondent Contact HARLAN L SATROM
Regulation Number872.4200
Classification Product Code
EFB  
Date Received05/20/1988
Decision Date 06/22/1988
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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