De Novo DEN240077

Device
MuReva OM™
Contact
vedang kothari
De Novo number
DEN240077
Product code
SGQ
Regulation
872.5595
Classification name
intraoral phototherapy device
Decision
granted (DENG)
Decision date
2025-11-26
Date received
2024-12-23
Classification advisory
Dental
Review advisory
Dental
Type
Direct

Current FDA Classification#

Product code
SGQ
Device name
Intraoral Phototherapy Device
Medical specialty
Dental
Device class
2
Regulation
872.5595
Implant
N
Life sustain/support
N