Lingua-Fix®
Basic Information
- Primary DI
- 00840161304735
- Basic UDI-DI Code
- B-00840161304735
- Reference
- 50Z953S
- Device Types
-
Single use
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Zirc Dental Products Inc.
Additional Description
Product device description: The Lingua-Fix® is a device comprised of four components which together create a saliva ejector that is used during dental procedures. The components consist of an angle tube and a chin rest; both made of polypropylene. A tube which is made of polyethylene. And a piece of gauze made of a Polyester/Polyethylene based non-woven fabric. Intended use of the product: The Lingua-Fix® is a device used for low volume evacuation of fluids from the oral cavity, during dental procedures in which sterile devices are not required. (Lingua-Fix® is not a sterile device). It is connected to a saliva ejector valve, which is used in conjunction with low volume evacuation systems. The large surface area of the suction (covered by the gauze) also protects the patients tongue during the procedure and assists in keeping the working area dry.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q019001 | SALIVA ASPIRATORS AND SALIVA ABSORBENTS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 41377454 | INTERTEK SEMKO AB | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).