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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, Root-Form
510(k) Number K915375
Device Name ODONTIT OSSEOINTEGRATED IMPLANTS SYSTEM
Applicant
Odontit Systeme
8309 Byrant Dr.
Bethesda,  MD  20817
Applicant Contact NEAL DUNNING
Correspondent
Odontit Systeme
8309 Byrant Dr.
Bethesda,  MD  20817
Correspondent Contact NEAL DUNNING
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/29/1991
Decision Date 06/03/1992
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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