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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 K921246
Device Name IMZ SURGICAL INSTRUMENT TRAY
Applicant
Interpore Intl.
18008 Skypark Cir.
Irvine,  CA  92714
Applicant Contact WILLIAM FRANKLIN
Correspondent
Interpore Intl.
18008 Skypark Cir.
Irvine,  CA  92714
Correspondent Contact WILLIAM FRANKLIN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received03/16/1992
Decision Date 06/22/1992
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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