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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Burnisher, Operative
510(k) Number K894896
Device Name ANSWER DENTAL IMPLEMENT, EXPLORER
Applicant
Tern Chien Ent. Co., Ltd.
P.O. Box 1730
213 E. Crawford St., #100
Findlay,  OH  45839
Applicant Contact WILL A SHINEW
Correspondent
Tern Chien Ent. Co., Ltd.
P.O. Box 1730
213 E. Crawford St., #100
Findlay,  OH  45839
Correspondent Contact WILL A SHINEW
Regulation Number872.4565
Classification Product Code
EKJ  
Date Received08/01/1989
Decision Date 10/30/1989
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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