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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter
510(k) Number K251724
Device Name Remi Impression Material
Applicant
Grindguard, Inc.
155 Jackson St.
1206
San Francisco,  CA  94111
Applicant Contact Oscar Adelman
Correspondent
Prime Path Medtech
1321 Upland Dr.
Suite 6792
Houston,  TX  77043
Correspondent Contact Jennifer Day
Regulation Number872.3660
Classification Product Code
SHI  
Date Received06/04/2025
Decision Date 02/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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