234110

Organization name

ACTEON MANUFACTURING

SRN

FR-MF-000007556

Manufacturer status

Active

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

• CW008

  Suspected rootcanal perforation.
• CW129

  May produce an allergic reaction. Known allergy to eugenol.
• CW999

  Do not use for immature teeth (for example in children).
• CW011

  The use of this product requires prior questioning, to understand the situation and find out the patient’s history. Mechanical preparation of root canal can lead to painful events, unrelated to the sealing cement. To avoid the risk of staining the dentin, do not fill the pulp chamber with cement and apply a cavity liner. Glucocorticoid medication use during pregnancy has been associated with an increased risk of cleft palate and impaired fetal growth, at higher doses than present in CORTISOMOL SP cement. CORTISOMOL SP cement should only be administered during pregnancy if the benefit of treatment outweighs a potential risk to the fetus. Prednisolone is known to pass into breast milk in small quantities when administered to lactating women; however, the levels in breastfed infants are likely to be too low to produce clinically significant effects. CORTISOMOL SP cement can be used during breastfeeding if necessary.
• CW083

  EUDAMED did not publish a description for this code.
• CW085

  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.
• CW414

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

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

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

  Dispose of the contents/containers in accordance with the current legislation on waste treatment.
• CW999

  Do not use if the liquid looks different (color, odor etc.) or if the consistency of the cement obtained after mixing with CORTISOMOL SP powder is not creamy and homogeneous, and easy to pick-up with a lentulo.

Primary placement in France; available across 15 countries total.

Trade name

not provided

UDI-DI code

03760243000928

Basic UDI-DI

376024300eugenolUX

Reference / catalog number

234110

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

1 bottle of 60 ml in a box with an instruction for use.

Additional information URL

https://www.acteongroup.com/documentation

Clinical sizes

No clinical sizes registered for this device.

• Q01010202ROOT CANAL FILLING DENTAL CEMENTS

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