De Novo DEN170090
- Device
- MATRx plus
- Contact
- sabrina bruehlmann
- De Novo number
- DEN170090
- Product code
- QCJ
- Regulation
- 872.5571
- Classification name
- closed loop auto titration device for oral appliances
- Decision
- granted (DENG)
- Decision date
- 2018-08-23
- Date received
- 2017-12-21
- Classification advisory
- Dental
- Review advisory
- Dental
- Type
- Direct
Current FDA Classification#
- Product code
- QCJ
- Device name
- Closed Loop Auto Titration Device For Oral Appliances
- Medical specialty
- Dental
- Device class
- 2
- Regulation
- 872.5571
- Implant
- N
- Life sustain/support
- N