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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Condyle, Mandibular, Temporary
510(k) Number K031701
Device Name OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
Applicant
Osteomed LP
3885 Arapaho Rd.
Addison,  TX  75001
Applicant Contact DAWN T HOLDEMAN
Correspondent
Osteomed LP
3885 Arapaho Rd.
Addison,  TX  75001
Correspondent Contact DAWN T HOLDEMAN
Regulation Number872.4770
Classification Product Code
NEI  
Date Received06/02/2003
Decision Date 07/08/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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