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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Root Canal Filling
510(k) Number K253909
Device Name NeoPEX™ Pre-Mixed Obturation Paste
Applicant
NuSmile, Ltd.
3315 W. 12th St.
Houston,  TX  77008
Applicant Contact Priscilla Lara
Correspondent
NuSmile, Ltd.
3315 W. 12th St.
Houston,  TX  77008
Correspondent Contact Priscilla Lara
Regulation Number872.3820
Classification Product Code
KIF  
Subsequent Product Code
EJK  
Date Received12/08/2025
Decision Date 09/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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