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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Locator, Root Apex
510(k) Number K181087
Device Name Apex Locator, DPEX III
Applicant
Guilin Woodpecker Medical Instrument Co., Ltd.
Information Industrial Park, Guilin National High-Tech Zone
Guilin City,  CN 541004
Applicant Contact Xunxian Wu
Correspondent
Irc
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charlie Mack
Classification Product Code
LQY  
Date Received04/25/2018
Decision Date 12/18/2018
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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