/

Trade name

not provided

UDI-DI code

06942480720471

Basic UDI-DI

694138229913HJ

Reference / catalog number

/

Issuing entity

GS1

Risk category

Class IIa

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.

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

• Q01010199DENTAL RESTORATION DEVICES - OTHER

2 warnings recorded — scroll inside the panel to see all entries.

• CW011

  1. Federal Law restricts this device to sale by or on the order of a dentist; 2. Residual methyl methacrylate monomer content (percent mass fraction): ≤2.2%.
• CW999

  Safety instruction: 1. Please use this product strictly in accordance with the product instruction manual and do not use it on occasions other than those specified in the product instruction manual. 2. During the processing of this product, please use protective glasses, a dust collection device and an effective breathing mask to avoid inhaling dust. 3. When this product is cracked or defective, please wear protective gloves to avoid scratches on your hands. 4. This product should be made and used by relevant dental professionals. 5. If hypersensitive to acrylic resin materials, great caution must be taken when using this product. 6.This product should be placed out of the reach of children.

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