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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 K862854
Device Name OSTEO TITANIUM DENTAL IMPLANT
Applicant
Osteo Implant Corp.
2415 Wilmington Rd.
New Castle,  PA  16105
Applicant Contact STEVEN B LOMBARDI
Correspondent
Osteo Implant Corp.
2415 Wilmington Rd.
New Castle,  PA  16105
Correspondent Contact STEVEN B LOMBARDI
Regulation Number872.3640
Classification Product Code
DZE  
Date Received07/29/1986
Decision Date 02/10/1987
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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