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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Setter, Band, Orthodontic
510(k) Number K935156
Device Name DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTS
Applicant
Dentauraum, Inc.
10 Pheasant Run
Newtown,  PA  18940
Applicant Contact JOHN J ROTH, JR.
Correspondent
Dentauraum, Inc.
10 Pheasant Run
Newtown,  PA  18940
Correspondent Contact JOHN J ROTH, JR.
Regulation Number872.4565
Classification Product Code
ECR  
Date Received10/28/1993
Decision Date 02/03/1994
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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