(8012)000003000003000003

Organization name

Dicomlab Dental Kutatás-fejlesztési Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság

SRN

HU-MF-000014062

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW011

  Contraindications: • The contraindications are the same as those for conventional freehand implant surgery.2 • Absolute contraindications: any serious condition or untreated disease including diseases of the bones, their metabolism, disorders of blood coagulation, diseases of the cardiovascular system, immune diseases, neoplasia, etc., treatment with bisphosphonates, immunosuppressed states, alcohol or drug abuse, poor compliance of the patient and/or relatives (or a complete lack thereof) due to pathologically altered mental functioning or otherwise. • Relative contraindications: radiotherapy (for 2 years after irradiation), uncontrolled diabetes, hemorrhagic diathesis or anticoagulant therapy, heavy smoking. • Temporary contraindications: untreated periodontal disease, retained root in the intended implantation site, local infection, untreated potential foci (untreated caries, periapical processes, etc.), poor oral hygiene, transient infective diseases (bacterial or viral), other contraindication of surgery in general (e.g. acute infection with fever), age under 18 years, pregnancy. • Relative local contraindications: erosive or bullous disease of the oral mucosa (because of local or systemic reasons), bruxism, parafunction, advanced atrophy of the jawbone.

Primary placement in Hungary; available across 8 countries total.

Trade name

not provided

UDI-DI code

05999861733002

Basic UDI-DI

5999861733SW01RL

Reference / catalog number

(8012)000003000003000003

Issuing entity

GS1

Risk category

Class IIb

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

https://cloud.dicomlab.com/app/profile/documents

Clinical sizes

No clinical sizes registered for this device.

• Z12110192INSTRUMENTS FOR DENTAL TREATMENT UNITS - MEDICAL DEVICE SOFTWARE

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

This device is not currently linked to any other device.