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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 K791491
Device Name BIOLITE CARBON COATED DENTAL IMPLANT
Applicant
Carbomedics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Carbomedics, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/06/1979
Decision Date 09/04/1979
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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