FDA 510(k) Application Details - K202786

Device Classification Name Handpiece, Air-Powered, Dental

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510(K) Number K202786
Device Name Handpiece, Air-Powered, Dental
Applicant MicroP Technology (Taiwan), Inc.
No.50, Zhongxiao 2nd St., East Dist, Chiayi City 600, Taiwan
(R.O.C)
Chiayi City 600 TW
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Contact Ina Lin
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Regulation Number 872.4200

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Classification Product Code EFB
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Date Received 09/22/2020
Decision Date 09/03/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K202786


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