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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 K951016
Device Name DISPOSABLE PROPHYLAXIS ANGLE
Applicant
Preventive Technologies, Inc.
1201 Wood Ridge Center Dr.
Suite 112
Charlotte,  NC  28217
Applicant Contact AL K ING
Correspondent
Preventive Technologies, Inc.
1201 Wood Ridge Center Dr.
Suite 112
Charlotte,  NC  28217
Correspondent Contact AL K ING
Regulation Number872.6290
Classification Product Code
EHK  
Date Received03/06/1995
Decision Date 05/02/1995
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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