7050

Organization name

Saremco Dental AG

SRN

CH-MF-000042507

Manufacturer status

Active

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

• CW999

  Close containers after each use with the right lid. Keep out of reach of children. For dental use only. When using tips, make sure, that before usage the cap has been removed. Commercially available medical gloves do not provide protection against the sensitization effect of methacrylates. If the product comes in contact with the glove, remove the glove and dispose of it, wash your hands with water and soap immediately and put on a new glove. In case of an allergic reaction, seek medical advice. When polishing or removing composites, it is recommended to always use a water-cooling system and a good extraction system, to ventilate the dental laboratory frequently and to wear masks with high particle filtration efficiency for small particle sizes. Light-curing restorative materials can be processed quickly, as the polymerization can be started by the ambient light of the dental treatment lamp
• CW011

  Close containers after each use with the right lid. Keep out of reach of children. For dental use only. When using tips, make sure, that before usage the cap has been removed. Commercially available medical gloves do not provide protection against the sensitization effect of methacrylates. If the product comes in contact with the glove, remo- ve the glove and dispose of it, wash your hands with water and soap imme- diately and put on a new glove. In case of an allergic re- action, seek medical advice. When polishing or removing composites, it is recommended to always use a water-cooling system and a good extraction system, to venti- late the dental laboratory frequently and to wear masks with high particle filtration efficiency for small particle sizes. Light-curing restorative materi- als can be processed quickly, as the polymerization can be started by the ambient light of the dental treatment lamp

Primary placement in Germany; available across 9 countries total.

Trade name

not provided

UDI-DI code

+D93170501

Basic UDI-DI

++D9311000Y9

Reference / catalog number

7050

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

els composite is a light-curing, highly filled, radio-opaque micro hybrid filling composite with extremely low shrinkage stress for permanent anterior and posterior dental restorations. els composite is a polymer-based restorative material type 1, class 2, group 1 and 2 according to DIN EN ISO 4049. A dental adhesive, such as manufactured by SAREMCO Dental AG, is used to permanently bond the restoration to the tooth structure. els composite is available in a wide variety of (Vita) shades. It is packaged in traditional syringes and tips

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Q01010103DENTAL RESTORATIVE COMPOSITES

• Batch number
• Expiration date
• Manufacturing date
• Serial number
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This device is not currently linked to any other device.