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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 K053629
Device Name ANCHOR PLUS/NEO ANCHOR PLUS
Applicant
Kj Meditech
340 Shady Grove Rd.
Flintville,  TN  37335
Applicant Contact CHARLIE MACK
Correspondent
Kj Meditech
340 Shady Grove Rd.
Flintville,  TN  37335
Correspondent Contact CHARLIE MACK
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/29/2005
Decision Date 05/31/2006
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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