Organization name

INTERDENT proizvodnja in trgovina, d.o.o.

SRN

SI-MF-000004584

Manufacturer status

Active

+D05800000000017500

DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.

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

• Consult instructions for use
• H302 – Harmful if swallowed.
• H350 – May cause cancer.

  May cause cancer by inhalation.

• H341 – Suspected of causing genetic defects.
• H360 – May damage fertility or the unborn child.

  May damage fertility. Suspected of damaging the unborn child.

• H334 – May cause allergy or asthma symptoms or breathing difficulties if inhaled.
• H317 – May cause an allergic skin reaction.
• H413 – May cause long lasting harmful effects to aquatic life.
• 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.
• P264 – Wash thoroughly after handling.
• P270 – Do not eat, drink or smoke when using this product.
• P272 – Contaminated work clothing should not be allowed out of the workplace.
• P273 – Avoid release to the environment.
• P280 – Wear protective gloves/protective clothing/eye protection/face protection.
• P281 – Use personal protective equipment as required.

  To protect against dust generated during material machining, dust extraction, protective gloves, safety goggles, and a protective mask with a FFP3 filter are required.

• P301 – IF SWALLOWED: P312 – Call a POISON CENTER or doctor/physician if you feel unwell.
• P304 – IF INHALED: P340 – Remove victim to fresh air and keep at rest in a position comfortable for breathing.
• P308 – IF exposed or concerned: P313 – Get medical advice/attention.
• P333 – If skin irritation or rash occurs: P313 – Get medical advice/attention.
• P342 – If experiencing respiratory symptoms: P311 – Call a POISON CENTER or doctor/physician.
• Contraindications: In case of a known allergy to the content of the alloy. Not suitable for fabrication of a direct abutment over an implant.

  OTHER

• Interaction! In case of occlusal or approximal contacts of different alloys, electrochemical reactions may occur in rare cases.

  OTHER

• Side effects: Please note the possibility of allergic sensitisation to the contents of the alloy.

  OTHER

• GHS08 - Danger or Warning - Systemic health hazards
• GHS07 - Warning -Toxic cat. 4, Irritant cat. 2 or 3, Lower systemic health hazards

Primary placement in Slovenia; available across 32 countries total.

Trade name

LaAlloy

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.

+D05800000000017500

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.

++D058DENTALALLOYS2A3DPV2

Reference / catalog number

REF 1750

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.

HIBCC

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

Cobalt-based dental alloy powder, 5 kg

Additional information URL

https://shop-interdent.si/f/docs/Download/Laalloy-instructions-for-use.pdf

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.

• Q010601DENTAL ALLOYS

• Class IIa medical devices in EUDAMED

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

Certificate health across this manufacturer's portfolio.