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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Positioner, Tooth, Preformed
510(k) Number K942667
Device Name DENT-O-CRYL ORTHODONTIC ACRYLIC
Applicant
DENTAURAUM, INC.
10 PHEASANT RUN
NEWTOWN,  PA  18940
Applicant Contact JOHN J ROTH
Correspondent
DENTAURAUM, INC.
10 PHEASANT RUN
NEWTOWN,  PA  18940
Correspondent Contact JOHN J ROTH
Regulation Number872.5525
Classification Product Code
KMY  
Date Received06/06/1994
Decision Date 02/13/1995
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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