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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Belt And/Or Gear Driven, Dental
510(k) Number K092412
Device Name STRONG IMPLANT HANDPIECES
Applicant
Saeshin Precision Co., Ltd.
1007, Byucksan 2cha
481-10,Gasan-Dong,Geumcheon-Gu
Seoul,  KR
Applicant Contact SEONG NAM KIM
Correspondent
Underwriters Laboratories, Inc.
1285 Walt Whitman Rd.
Melville,  NY  11747
Correspondent Contact MARC M MOUSER
Regulation Number872.4200
Classification Product Code
EFA  
Date Received08/06/2009
Decision Date 09/03/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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