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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mouthguard, Over-The-Counter
510(k) Number K260790
Device Name G-Series Grind Guard
Applicant
ASESSO HEALTH, Inc.
4128 Stanley Blvd.
Pleasanton,  CA  94566
Applicant Contact Abhijit Limaye
Correspondent
ASESSO HEALTH, Inc.
4128 Stanley Blvd.
Pleasanton,  CA  94566
Correspondent Contact Abhijit Limaye
Classification Product Code
OBR  
Date Received03/11/2026
Decision Date 06/25/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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