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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cup, Prophylaxis
510(k) Number K864059
Device Name DENTAL PROPHY CUPS (VARIOUS TYPES)
Applicant
Mission White Dental, Inc.
31 Park Rd.
Tinton Falls,  NJ  07724
Applicant Contact JOSEPH J BUTLER
Correspondent
Mission White Dental, Inc.
31 Park Rd.
Tinton Falls,  NJ  07724
Correspondent Contact JOSEPH J BUTLER
Regulation Number872.6290
Classification Product Code
EHK  
Date Received10/20/1986
Decision Date 11/19/1986
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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