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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 K101201
Device Name STRAIGHT ABUTMENT, 4.2, 4.6, 5.0, 6.4, IMPLANT 6.0, IMPLANT 7.0, IMPLANT 8.0 MODEL: 002061, 002062, 002063, 002064,
Applicant
Kat Implants, LLC
15 Rye St.
Suite 115
Portsmouth,  NH  03801
Applicant Contact VITALI BONDAR
Correspondent
Kat Implants, LLC
15 Rye St.
Suite 115
Portsmouth,  NH  03801
Correspondent Contact VITALI BONDAR
Regulation Number872.3640
Classification Product Code
DZE  
Date Received04/29/2010
Decision Date 04/13/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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