Eu Mdr
Eu Md Class 1
On The Market
🇺🇸 United States
HybenX® OTD Gel
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 00860004740322
- Basic UDI-DI Code
- 03629421035002GA
- Reference
- 103-5002
- Device Types
-
Single use
- Regulation
- Eu Mdr
- Classification
- Eu Md Class 1
- Status
- On The Market
- Manufacturer
- EPIEN Medical, Inc
Additional Description
HybenX® Professional Product is a semi-viscous, opaque dark purple, topical liquid blend of aromatic sulphonic acids and sulphuric acid in water. It is applied to the periodontium or endodontium in the form of an irrigation either before and/or after standard mechanical oral hygiene procedures to assist in the removal of dental plaque biofilm by physical means.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q019007 | BUCCAL TOPICAL TREATMENT PREPARATIONS NOT INCLUDED IN OTHER CLASSES |
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