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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 K894160
Device Name HAND TOOLS FOR ARTECH TYPE SS SUBMERGED SCREW IMPL
Applicant
Artech Corp.
14554 Lee Rd.
Chantilly,  VA  22021
Applicant Contact HENRY HAHN
Correspondent
Artech Corp.
14554 Lee Rd.
Chantilly,  VA  22021
Correspondent Contact HENRY HAHN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/14/1989
Decision Date 09/28/1989
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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