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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 K843217
Device Name HOLLOW BASKET DENTAL IMPLANTS
Applicant
Artech Corp.
2901 Telestar Ct.
Falls Church,  VA  22042
Applicant Contact HENRY HAHN
Correspondent
Artech Corp.
2901 Telestar Ct.
Falls Church,  VA  22042
Correspondent Contact HENRY HAHN
Regulation Number872.3640
Classification Product Code
DZE  
Date Received08/15/1984
Decision Date 10/15/1984
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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