HELIOTONE+ AUTO VR4 100g + 50 ml

Organization name

EVERALL7 SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

SRN

PL-MF-000018646

Manufacturer status

Active

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

• CW999

  Do not use the products by people diagnosed with a lack of resistance to allergenic factors, including the ingredients of the product. In such situations, use a different material suitable for the patient.
• CW999

  Do not carry out repairs, relining or other work using the direct method in the patient’s mouth.
• CW999

  Do not use the product by pregnant women and nursing mothers in the group of dental technicians.
• CW038

  EUDAMED did not publish a description for this code.
• CW057

  EUDAMED did not publish a description for this code.
• CW082

  EUDAMED did not publish a description for this code.
• CW083

  EUDAMED did not publish a description for this code.
• CW090

  EUDAMED did not publish a description for this code.
• CW139

  EUDAMED did not publish a description for this code.
• CW159

  EUDAMED did not publish a description for this code.
• CW162

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 1 country total.

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

Trade name

HELIOTONE+ AUTO VR4 100g + 50 ml

UDI-DI code

05901602127094

Basic UDI-DI

590160212REPFP

Reference / catalog number

3166934

Issuing entity

GS1

Risk category

Class I

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

Self-curing acrylic resin for making dentures repairs. The set contains 100g of VR4 color powder and 50ml of liquid compatible with the powder.

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.

• Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER