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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 K945077
Device Name INSTRUMENT,FILLING,PLASTIC,DENTAL
Applicant
Worldwide Dental, Inc.
12890 Automobile Blvd.,
Suite A
Clearwater,  FL  34622
Applicant Contact WILLIAM M DOMIN
Correspondent
Worldwide Dental, Inc.
12890 Automobile Blvd.,
Suite A
Clearwater,  FL  34622
Correspondent Contact WILLIAM M DOMIN
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received10/17/1994
Decision Date 11/30/1994
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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