Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Let the assistant research this device
The Research Assistant compiles risk class, certificates, notified bodies and related records — and cites every one.
Free to try · every answer cites its records
Basic Information
- Primary DI
- 10692121035435
- Basic UDI-DI Code
- 69212103543NP
- Reference
- 03543
- Device Types
- None provided
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- Splintek, Inc.
Additional Description
SleepRight Ultra-Comfort is indicated for the protection against bruxism or night-time teeth grinding. It is used to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q010699 | MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER |
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 1) and regulation (EU MDR).
ORTHODONTIC DEVICES - OTHER
Device
EU MDR
·
Eu Md Class 1
·LEONE S.P.A.·On the market·32 countries
Catalyst 5
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Catalyst 4
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Catalyst 5VX
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Little Wave Spark
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market
Little Wave Clik
Device
EU MDR
·
Eu Md Class 1
·Ki Mobility LLC·On the market