Organization name

ACTEON MANUFACTURING

SRN

FR-MF-000007556

Manufacturer status

Active

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

• Biological risks

  Suspected rootcanal perforation.

• EUH 208 – Contains (name of sensitising substance). May produce an allergic reaction.

  May produce an allergic reaction. Known allergy to eugenol.

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

  OTHER

• Caution

  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.

• H317 – May cause an allergic skin reaction.
• H319 – Causes serious eye irritation.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P264 – Wash thoroughly after handling.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P302 – IF ON SKIN: P351 – Rinse cautiously with water for several minutes.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• Dispose of the contents/containers in accordance with the current legislation on waste treatment.

  OTHER

• 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.

  OTHER

Primary placement in France; available across 15 countries total.

Trade name

EUGENOL PUR

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

03760243000928

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

376024300eugenolUX

Reference / catalog number

234110

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

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.

1 packaging level registered — each level carries its own UDI-DI.

• 03760243000928× 1 unitBase unit
  • 03760243007118× 1 unit

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

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

• Q01010202ROOT CANAL FILLING DENTAL CEMENTS

• Class IIa medical devices in EUDAMED

• 39305Supplemented
  Quality management systemNotified body: GMED SAS (0459)Expiry: May 24, 2028

Certificate health across this manufacturer's portfolio.