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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K221548
Device Name Dental Air Polishing Handpiece
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 Charles Mack
Regulation Number872.4200
Classification Product Code
EFB  
Date Received05/27/2022
Decision Date 09/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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