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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 K221761
Device Name Solea
Applicant
Convergent Dental, Inc.
140 Kendrick Street
Needham,  MA  02494
Applicant Contact Jhung Vojir
Correspondent
Convergent Dental, Inc.
140 Kendrick Street
Needham,  MA  02494
Correspondent Contact Jhung Vojir
Regulation Number878.4810
Classification Product Code
NVK  
Subsequent Product Code
GEX  
Date Received06/17/2022
Decision Date 09/14/2022
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
Recalls CDRH Recalls
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