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

ISTplus®-Set, laminating foils Ø… — Class I MDR

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

EUDAMED last updated this device on Jan 31, 2024

ISTplus®-Set, laminating foils Ø 125

4260620320054R

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: 04260620320841
Reference / catalog number: 982400

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

Related devices

Friedensstifter class I4260620320074VOn the market OrthoPreventAligner® prevention W-hard4260620320044POn the market BRUXI+, set4260620320034MOn the market BRUXI+, single4260620320034MOn the market Friedensstifter class II4260620320074VOn 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.

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: ISTplus®-Set, laminating foils Ø 125
UDI-DI code: 04260620320841
Basic UDI-DI: 4260620320054R
Reference / catalog number: 982400
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: The ISTplus® device acc. to Prof. Hinz is a development of the proven equipment. This appliance offers maximum wearing comfort with optimal space for ventral placement of the tongue due to its interocclusal guide rods, which are connected from the distal mandible to the mesial maxilla. The ISTplus® kit is the basis. It consists of two adjustable connecting bars and one safety and one Allen key each. In addition, you will receive the special LAMItec foils. In this special lamination process, two polycarbonate foils are joined with a soft intermediate layer. The holding devices for IST splints and attachments for protrusion splints are laminated between two foils. Advantages of the laminating process: Reinforcement of the only 1.3 - 2 mm laminated splints with auto-polymers is unnecessary: The section modulus and flexural strength increase, making the rails virtually unbreakable. Area discolouration, as occurs with conventional hard-soft splints, is avoided: The colour-sensitive layer is on the inside in this process. The accumulation of plaque is minimized by the smooth, crystal-clear surfaces of the deep-drawn splints. Incl. polymer, monomer, bite fork and storage box.
Additional information URL: https://www.dr-hinz-dental.de/shop/de/982400?q=982400
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