Gutta Percha Points Aurum Pro F4

Organization name

META BIOMED CO., LTD.

SRN

KR-MF-000009681

Manufacturer status

Active

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

• CW011

  "① Do not use this product for any patients with a history of hypersensitivity reactions to it, such as a rash, dermatitis, etc. ② Some patients have an allergic reaction to Trans 1,4 Polyisoprene materials and/or even experience hypersensitivity. Do not use this product for them ③ This product is intended only for use for the tissue inside the mouth. Be careful to prevent it from coming into contact with eyes. If material has come into contact with eyes or skin, wash immediately with plenty of water and then consult a doctor. ④ Non-specialists are prohibited from using this product. Do not use this product for any purposes other than its intended purposes. ⑤ Do not prescribe an internal medicine ⑥ Should be careful to avoid overfilling or dead space ⑦ Be sure to take measures for the protection of the respiratory tract before ⑧ Always close the slide lid after use space ⑨ Do not reuse. Reusing these products increases the risk of cross-contamination and/or breakage."

Primary placement in Germany; available across 7 countries total.

Trade name

Gutta Percha Points Aurum Pro F4

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.

08806387805441

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.

B-08806387805441

Reference / catalog number

-

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.

GS1

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

"Gutta percha points are root canal obturation material. It is used to fill the cleaned, shaped and irrigated root canal space. • Time saving with easy filling • For faster and easier root canal obturation • Variable tapers & sizes • Length marking available • Excellent radiopacity • Long shelf life and freshness assured • Suitable for vertical and lateral condensation"

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Q01010203DENTAL CONES

• Class IIa medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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