DeviceClearance

Product code SGQ— Dental

MuReva OM

Classification name
Intraoral Phototherapy Device
Device class
Class 2
Regulation
21 CFR 872.5595
Advisory panel
Dental
Total cleared
1
First cleared
Most recent

FDA classification definition

“An intraoral phototherapy device is an intraoral, non-ionizing, light-based device that is intended for non-surgical treatment of oral conditions such as oral mucositis.”

— U.S. Food and Drug Administration, device classification record for product code SGQ under 21 CFR 872.5595, via openFDA

Market context for product code SGQ

FDA has cleared 1 device under product code SGQ, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGQ

Recent clearances under product code SGQ

Data sourced from openFDA. This site is unofficial and independent of the FDA.