Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

BRUXI+, set — Class I MDR by Dr. Hinz Dental-Vertrieb…

MD Atlas
Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG

EUDAMED last updated this device on Jan 31, 2024

BRUXI+, set

4260620320034M

On the marketClass I

Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Organization name: Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG
UDI-DI code: 04260620320643
Reference / catalog number: 93805

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

Manufacturer information

Organization name: Dr. Hinz Dental-Vertriebsgesellschaft mbH & Co. KG
SRN: DE-MF-000006965
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: BRUXI+, set
UDI-DI code: 04260620320643
Basic UDI-DI: 4260620320034M
Reference / catalog number: 93805
Issuing entity: GS1

Classification

Risk category: Class I
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: Nocturnal teeth grinding is widespread: about 20% of all children and adolescents are affected. Noisy teeth grinding can occur as early as after the eruption of the milk cheek teeth in the 2nd year of life. Applied at an early stage - from the age of 3 - BRUXI+ can be used to permanently break the habit of grinding. The contourless BRUXI+ resembles an impression tray and has the external appearance of a splint that can be made individually. For this purpose, an impression is made directly in the patient's mouth using "DIRECT for BRUXI+. It hardens in the mouth after only about 90 seconds. The set contains 50 ml DIRECT for BRUXI+, 8 ml SILCOfix, 4 BRUXI+, 4 mixing tips. Incl. storage box and instructions for use.
Additional information URL: https://www.dr-hinz-dental.de/shop/de/bruxi-set-93805
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Q010499ORTHODONTIC DEVICES - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Friedensstifter class I4260620320074VOn the market OrthoPreventAligner® prevention W-hard4260620320044POn the market BRUXI+, single4260620320034MOn the market Friedensstifter class II4260620320074VOn the market IST bite fork4260620320064TOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.