Organization name

ACTEON MANUFACTURING

SRN

FR-MF-000007556

Manufacturer status

Active

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

• Contains a medicinal substance

  Prednisolone acetate.

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

  Patients with known allergies to any of the component of the powder (especially prednisolone acetate and iodine derivatives).

• Biological risks

  Suspected root canal perforation.

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

  OTHER

• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P272 – Contaminated work clothing should not be allowed out of the workplace.
• P273 – Avoid release to the environment.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P302 – IF ON SKIN: P352 – Wash with plenty of soap and water.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• P391 – Collect spillage.
• P501: Dispose of contents and/or containers in accordance with regulations on hazardous waste or packaging and packaging waste.

  OTHER

• Do not use if the powder looks different (color, clumps…) or if the consistency of the cement obtained after mixing with eugenol is not creamy and homogeneous, and easy to pick-up with a lentulo.

  OTHER

• Caution

  The use of this product requires a preliminary interview to understand the situation and know the patient's history. Mechanical treatment of the canals can generate painful phenomena not related to the obturation cement. To avoid possible staining of the dentine, do not fill the pulp chamber with cement and apply an isolating cavity liner. The use of glucocorticoids during pregnancy has been associated with an increased risk of cleft palate and fetal growth defects, at doses higher than those present in CORTISOMOL SP cement. CORTISOMOL SP cement should be used during pregnancy only if the benefit of treatment outweighs the potential risk to the fetus. Prednisolone is known to pass into breast milk in small amounts when administered to nursing mothers; however, concentrations in nursing infants are probably too low to produce clinically significant effects. CORTISOMOL SP cement may be used during lactation if necessary.

Primary placement in France; available across 15 countries total.

Trade name

CORTISOMOL SP

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.

03760243001062

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.

376024300obturationL5

Reference / catalog number

221606

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 III

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

CORTISOMOL SP (reference 221 606) box containing : •1 jar of 20g of powder ; •1 instruction for use ; •1 spoon (only an aid to sampling the powder).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• 03760243001062× 1 unitBase unit
  • 03760243007200× 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 III medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

• 40031Supplemented
  Technical documentationNotified body: GMED SAS (0459)Expiry: Oct 9, 2029
• 39305Supplemented
  Quality management systemNotified body: GMED SAS (0459)Expiry: May 24, 2028