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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 K855032
Device Name IMZ INTRAMOBILE CYLINDER IMPLANT
Applicant
Interpore Intl.
18008 Skypark Cir.
Irvine,  CA  92714
Applicant Contact JO STEGWELL
Correspondent
Interpore Intl.
18008 Skypark Cir.
Irvine,  CA  92714
Correspondent Contact JO STEGWELL
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/16/1985
Decision Date 03/03/1986
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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