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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name material, impression
510(k) Number K213175
Device Name No Stress Impress
No Stress Impress LLC
2012 Scrimshaw PL
Wilmington,  NC  28405
Applicant Contact Misael Otero
Wagoner Consulting LLG
5215 Crosswinds Drive
Wilmington,  NC  28409
Correspondent Contact Cheryl Wagoner
Regulation Number872.3660
Classification Product Code
Date Received09/28/2021
Decision Date 01/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No