DENTAL TREATMENT UNITS
Basic Information
- Primary DI
- 08800000995045
- Basic UDI-DI Code
- B-08800000995045
- Reference
- K3 Mount
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- OSSTEM IMPLANT Co., Ltd. Chair Business
Additional Description
A Dental Unit and Chair K3 is designed for dental treatment of children and adults. It is a dental treatment unit in accordance with IEC 80601-2-60. The 3-way syringe is a dental instrument in accordance with EN 1639. It aids the dental application in the mouth of the patient by supplying air, water or spray. This product is designed for use in dentistry only and may only be used by trained medical personnel. K3 is similar to other commercially available products based on the intended use, the technology used, the claims, the electrical power and performance characteristics. It is substantially equivalent in design, function and intended use to the predicate devices.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12110101 | DENTAL TREATMENT UNITS |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 243633-2017-CE-KOR-NA-PS, C679942 | DNV Product Assurance AS |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).