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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 K213428
Device Name EdgePro
Applicant
Biolase, Inc.
27042 Towne Centre Dr., Suite 270
Foothill Ranch,  CA  92610
Applicant Contact Ed Balcos
Correspondent
Biolase, Inc.
27042 Towne Centre Dr., Suite 270
Foothill Ranch,  CA  92610
Correspondent Contact Ed Balcos
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Code
GEX  
Date Received10/21/2021
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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