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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

1700493-001 — Class IIa MDD by Bien-Air Dental SA

MD Atlas
Bien-Air Dental SA

EUDAMED last updated this device on Jul 2, 2024

1700493-001

B-J00717004930011

On the marketClass IIa

Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Organization name: Bien-Air Dental SA
UDI-DI code: J00717004930011
Reference / catalog number: 1700493-001

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Manufacturer information

Organization name: Bien-Air Dental SA
SRN: CH-MF-000014661
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Market distribution

Primary placement in Austria; available across 1 country total.

Country	On market since	Until
AustriaPrimary placement		Still on market

Device identification

Trade name: not provided
UDI-DI code: J00717004930011
Basic UDI-DI: B-J00717004930011
Reference / catalog number: 1700493-001
Issuing entity: HIBCC

Classification

Risk category: Class IIa
Applicable legislation: MDD [Directive 93/42/EEC on medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: These systems are to be used by dentists and surgeons in dental offices and hospitals. Each unit is designed to control a dental MX-i micromotor which can drive a dental hand-piece fitted with appropriate tools to cut hard and soft tissues in the mouth and to screw dental implants. The systems (iChiropro, iChiropro Surgery and Osseocare Pro) are intended for use in dentistry for implantology and dental surgery.
Additional information URL: https://dental.bienair.com/de_ch/support/download-center/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

Z12110199INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER

Compliance flags

Safety

Sterile

Single use

Contains latex

Reprocessed single-use

Direct marking

Substances

CMR substance

Endocrine disruptor

Regulatory

Annex XVI applicable

Sterilization

Lifecycle

New device

UDI-PI traceability

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