TEMPORIS A3 DLty M

Organization name

DWS srl

SRN

IT-MF-000013530

Manufacturer status

Active

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

• he device should not be used for patients with possible allergy and/or hypersensitivity to methacrylate. A personal medical history including intolerances and allergies has to be taken before treating a patient.The application is to be avoided in: pediatric population, peripubertal males/females, pregnant women and breast-feeding women

  OTHER

• H317 – May cause an allergic skin reaction.
• H360 – May damage fertility or the unborn child.
• H411 – Toxic to aquatic life with long lasting effects.
• P201 – Obtain special instructions before use.
• P202 – Do not handle until all safety precautions have been read and understood.
• P261 – Avoid breathing dust/fume/gas/mist/vapours/spray.
• 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.
• Do not re-use
• Do not use if package is damaged
• Consult instructions for use
• Contains hazardous substances

Primary placement in Italy; available across 10 countries total.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q010699MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.