Organization name

Shandong Huge Dental Material Corporation

SRN

CN-MF-000013266

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• Consult instructions for use

  1)Dentist technicians who are hypersensitive to acrylate resin, and with a history of rash or dermatitis, etc., should avoid being exposed to this product. Also, the dentist should inquire whether the patient has such hypersensitivity history prior to installation of denture. 2)If the patient presents with allergic contact stomatitis, such as mild erythema or whiting mucosal surface, after installation of a denture made from this product, discontinue use immediately, and seek diagnosis and treatment by a specialist. 3)During operation, dentist technician should wear gloves, and avoid direct contact with liquid or non-hardening powder-liquid mixture of this product; in case of contact, immediately rinse and clean the hands with running water and soap. In case of inadvertent contact with eyes, immediately rinse eyes with a large amount of water, and seek diagnosis and treatment from an ophthalmolgist.

Primary placement in Germany; available across 32 countries total.

Trade name

Denture Base Polymers

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.

06970402677565

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.

6909412YCJT1013M

Reference / catalog number

Type 1 class 1(A) Traditional Heat Curing/Powder 250g

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.

GS1

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 I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Q0102050199DENTISTRY RESINS - OTHER

• Class I medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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