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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 K960541
Device Name LYNX DPA DISPOSABLE PROPHY ANGLE
Applicant
Mti Precision Products
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Applicant Contact ANNE MARIE CESARIO
Correspondent
Mti Precision Products
1129 Bloomfield Ave.
West Cadwell,  NJ  07006
Correspondent Contact ANNE MARIE CESARIO
Regulation Number872.4200
Classification Product Code
EFB  
Date Received02/07/1996
Decision Date 03/28/1996
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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