Organization name

KaVo Dental GmbH

SRN

DE-MF-000006471

Manufacturer status

Active

EKAV101070000

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

Primary placement in Germany; available across 29 countries total.

Trade name

not provided

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

EKAV101070000

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

++EKAVG001YA

Reference / catalog number

1.010.7000

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

HIBCC

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Dental treatment units are a device system consisting of a dental treatment unit and different defined application parts/accessories (e. g. dental handpieces) that are necessary to perform a dental treatment. The basis is the dental treatment unit consisting of a patient chair, the unit body including patient part and a dentist element with a predefined number of holders (depending on the model: 5-7 holders) for different application devices (Multiflex, INTRA LUX, Multifunction handpiece, scaler, curing light, intraoral camera). Additionally, there is a holder for one to two norm trays at the dentist element. Supplementary, the treatment unit has an assistant element with a predefined number of holders (depending on the model: 4-6 holders) for suction components as the HVE (high-volume ejector) and the surgical canula. As option it is possible to mount a curing light and/or a three-functional handpiece on the assistant element. Furthermore, the treatment unit has a foot control to control the system by foot and possibly an operating lamp (unit or ceiling mounted). Depending on the price range and the market segment there are further accessories possible for example a microscope, a screen, or an x-ray device. For hygiene purposes in the patient water there is a water germ reduction system integrated. With this system the instrument hoses could be rinsed simultaneously with water doped with germ reduction agent for germ reduction. A separation system for separating treatment particles (e.g. separator or amalgam separator) is also part of the treatment unit in order to minimize waste water pollution.

Additional information URL

https://www.kavo.com/download-center

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Z12110101DENTAL TREATMENT UNITS

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.