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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name intraoral phototherapy device
De Novo Number DEN240077
Device Name MuReva OM™
Requester
mureva phototherapy, inc.
8300 dow circle
suite 500
strongsville,  OH  44136
Contact vedang kothari
Regulation Number872.5595
Classification Product Code
SGQ  
Date Received12/23/2024
Decision Date 11/26/2025
Decision granted (DENG)
Classification Advisory Committee Dental
Review Advisory Committee Dental
Classification Order Classification Order
Type Direct
Predetermined Change
Control Plan Authorized		 No
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