266264

Organization name

ACTEON MANUFACTURING

SRN

FR-MF-000007556

Manufacturer status

Active

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

• CW008

  Suspected rootcanal perforation.
• CW129

  Known allergy to one of the components of the cement (in particular iodine and its derivatives and/or eugenol).
• CW999

  Do not use for immature teeth (for example in children).
• CW999

  Do not use for pregnant and breast-feeding women.
• CW999

  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.
• CW011

  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.
• CW082

  EUDAMED did not publish a description for this code.
• CW083

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

  EUDAMED did not publish a description for this code.
• CW104

  EUDAMED did not publish a description for this code.
• CW162

  EUDAMED did not publish a description for this code.
• CW166

  EUDAMED did not publish a description for this code.
• CW167

  EUDAMED did not publish a description for this code.
• CW422

  EUDAMED did not publish a description for this code.
• CW304

  EUDAMED did not publish a description for this code.
• CW226

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

  Dispose of contents and/or containers in accordance with regulations on hazardous waste or packaging and packaging waste.
• CW416

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

  EUDAMED did not publish a description for this code.
• CW159

  EUDAMED did not publish a description for this code.
• CW306

  EUDAMED did not publish a description for this code.

Primary placement in France; available across 14 countries total.

Trade name

not provided

UDI-DI code

03760243000911

Basic UDI-DI

376024300sealiterPY

Reference / catalog number

266264

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

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.

• Q01010202ROOT CANAL FILLING DENTAL CEMENTS

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