0032304

Organization name

lege artis Pharma GmbH + Co. KG

SRN

DE-MF-000006175

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW132

  EUDAMED did not publish a description for this code.
• CW135

  EUDAMED did not publish a description for this code.
• CW318

  EUDAMED did not publish a description for this code.
• CW193

  EUDAMED did not publish a description for this code.
• CW406

  EUDAMED did not publish a description for this code.
• CW305

  EUDAMED did not publish a description for this code.
• CW397

  EUDAMED did not publish a description for this code.
• CW416

  EUDAMED did not publish a description for this code.
• CW334

  EUDAMED did not publish a description for this code.
• CW999

  If during the vitality test a clear pain on heat occurs (perhaps throbbing with the pulsation) a preservation of the vital tooth is no longer possible (pulpectomy, treatment of gangrene).
• CW999

  Allergy to components of the cement, especially to eugenol and peru balsam.
• CW999

  Cp-CAP powder and Cp-CAP solution should be used together only and may not be mixed with other materials.
• CW999

  A direct contact with composites is to be avoided since eugenol softens synthetic materials.
• CW999

  Cp-CAP powder contains calcium hydroxide.
• CW999

  Avoid any contact with the eyes and the skin.
• CW999

  Avoid swallowing.
• CW999

  Avoid contact with clothing.
• CW999

  Do not return powder remainders into the container.
• CW999

  Please also note the instructions under Mode of application!

Primary placement in Germany; available across 3 countries total.

Trade name

not provided

UDI-DI code

111669969204

Basic UDI-DI

B-111669969204

Reference / catalog number

0032304

Issuing entity

IFA

Risk category

Class IIa

Applicable legislation

MDD [Directive 93/42/EEC 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.

• Q0101010299TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification