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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Dental, Soft Tissue
510(k) Number K201387
Device Name Ultrafast, Ultrafast Plus, Ultrafast Lite
Applicant
Dentlight, Inc.
1825 Summit Ave. Suite 210
Plano,  TX  75074
Applicant Contact Richard Liu
Correspondent
Dentlight, Inc.
1825 Summit Ave. Suite 210
Plano,  TX  75074
Correspondent Contact Richard Liu
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Code
GEX  
Date Received05/27/2020
Decision Date 02/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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