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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 K950893
Device Name KIS-V PRE-ANGULATED AND WIDE BODY ABUTMENTS
Applicant
The Implant Center of the Palm Beaches
824 Us Hwy. 1
Suite 370
N. Palm Beach,  FL  33408
Applicant Contact JACK T KRAUSER
Correspondent
Megagen Implant Co., Ltd.
45 Secheon-Ro, 7-Gil
Dasa-Eup, Dalseong-Gun
Daegu,  KR
Correspondent Contact Hyo-Eun Lee
Regulation Number872.3640
Classification Product Code
DZE  
Date Received02/28/1995
Decision Date 05/05/1995
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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