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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Transmandibular
510(k) Number K852894
Device Name ORMCO TRANSMANDIBULAR IMPLANT
Applicant
Ormco Corp.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Applicant Contact WENDELL LEE
Correspondent
Ormco Corp.
1332 S. Lone Hill Ave.
Glendora,  CA  91740
Correspondent Contact WENDELL LEE
Regulation Number872.4760
Classification Product Code
MDL  
Date Received07/09/1985
Decision Date 08/29/1985
Decision SE - Postmarket Surveillance Required (SESP)
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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