Organization name

ACTEON MANUFACTURING

SRN

FR-MF-000007556

Manufacturer status

Active

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

• Biological risks

  Suspected root canal perforation.

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

  May produce an allergic reaction : Known allergy to one of the ingredients of cement (particulary iodine or 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 (clumps, ect.) and/or the liquid (odor, etc...) look different or if the consistency of the cement obtained after mixing with the liquid is not creamy and homogeneous, and asy 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.
• 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: P352 – Wash with plenty of soap and water.
• P305 – IF IN EYES: P338 – Remove contact lenses, if present and easy to do. Continue rinsing.
• P305 – IF IN EYES: P351 – Rinse cautiously with water for several minutes.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• P337 – If eye irritation persists: P313 – Get medical advice/attention.
• P501 : Dispose of contents and/or containers in accordance with regulations on hazardous waste or packaging and packaging waste.

  OTHER

• P273 – Avoid release to the environment.

Primary placement in France; available across 14 countries total.

Trade name

SEALITE LIQUIDE

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.

03760243000867

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

266267

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

Box containing 1 bottle of 10 ml of liquid.

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.

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

• 03760243000867× 1 unitBase unit
  • 03760243007101× 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

Certificate health across this manufacturer's portfolio.