Organization name

ACTEON MANUFACTURING

SRN

FR-MF-000007556

Manufacturer status

Active

21 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.

  Known allergy to one of the components of the cement (in particular iodine and its derivatives and/or eugenol).

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

  OTHER

• Do not use for pregnant and breast-feeding women.

  OTHER

• Do not use if the powder and/or the liquid look different (powder agglomerate, odour) 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 dentin, do not fill the pulp chamber with cement and apply a cavity liner.

• H315 – Causes skin irritation.
• H317 – May cause an allergic skin reaction.
• H319 – Causes serious eye irritation.
• H410 – Very toxic to aquatic life with long lasting effects.
• P264 – Wash thoroughly after handling.
• 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.
• P337 – If eye irritation persists: P313 – Get medical advice/attention.
• P391 – Collect spillage.
• Dispose of contents and/or containers in accordance with regulations on hazardous waste or packaging and packaging waste.

  OTHER

• 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.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.

Primary placement in France; available across 14 countries total.

Trade name

SEALITE REGULAR

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.

03760243000911

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.

376024300sealiterPY

Reference / catalog number

266264

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

SEALITE REGULAR (reference 266264) : • 1 jar of 25 g of powder ; • 1 bottle of 10 ml of liquid ; • 1 spoon (aid to sampling the powder) and 1 dropper (aid to sampling the liquid) : accessories ; • 1 instruction for use.

Additional information URL

https://www.acteongroup.com/documentation%20/%20https://www.acteongroup.com/en/sealite-regular

Clinical sizes

No clinical sizes registered for this device.

• 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

Certificate health across this manufacturer's portfolio.