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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name implant, endosseous, orthodontic
510(k) Number K042965
Device Name TOMAS PIN
Applicant
DENTAURUM, INC.
10 PHEASANT RUN
NEWTOWN,  PA  18940
Applicant Contact THOMAS LIETZ
Correspondent
DENTAURUM, INC.
10 PHEASANT RUN
NEWTOWN,  PA  18940
Correspondent Contact THOMAS LIETZ
Regulation Number872.3640
Classification Product Code
OAT  
Date Received10/27/2004
Decision Date 04/15/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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