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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 K922872
Device Name INTERPORE CYLINDRICAL HEX HYDROXYAPATITE COATED IMPLANT, 3.3 MM DIAM.
Applicant
Interpore Intl.
18008 Skypark Cir.
Irvine,  CA  92714
Applicant Contact WILLIAM A FRANKLIN
Correspondent
Interpore Intl.
18008 Skypark Cir.
Irvine,  CA  92714
Correspondent Contact WILLIAM A FRANKLIN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/15/1992
Decision Date 07/25/1994
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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