0032309

Organization name

lege artis Pharma GmbH + Co. KG

SRN

DE-MF-000006175

Manufacturer status

Active

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

• CW010

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

  Allergies to components of the root canal filling material/-sealer.
• CW135

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

  The safety data sheet can be downloaded from www.legeartis.de or requested by E-Mail from sicherheitsdatenblaetter@legeartis.de.
• CW193

  EUDAMED did not publish a description for this code.
• CW319

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

  EUDAMED did not publish a description for this code.
• CW306

  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.
• CW304

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

  Avoid swallowing.
• CW999

  May cause skin and eye irritation.
• CW999

  Do not fill back residues of the solution or the powder into the bottle.
• CW999

  Note the instructions under Mode of application!
• CW999

  HERMETIC powder and HERMETIC 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 polymer materials.
• CW999

  If after the application of HERMETIC pain should arise, either the root canal was not exactly prepared or over-filled.

Primary placement in Germany; available across 5 countries total.

Trade name

not provided

UDI-DI code

111669976960

Basic UDI-DI

B-111669976960

Reference / catalog number

0032309

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.

• Q0101010202ROOT CANAL CEMENTS

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