REF 1954SMLB1

Organization name

INTERDENT proizvodnja in trgovina, d.o.o.

SRN

SI-MF-000004584

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW999

  Contraindications: Using in case of bruxism, inadequate strength of tooth structure or insufficient space is not recommended. Usage is also not recommended in case of inadequate oral hygiene or inadequate coordination of masticatory movements. Prosthetic substitutes made out of discs must not be used in case of unsatisfactory preparation of teeth and in case of mistakes in prosthetic substitute.
• CW999

  Safety precaution: Powder is harmful to health. Use suction unit. At manual treatment use protective mask FFP1 and wear goggles.
• CW999

  Side effects: Consider possibility of allergic hypersensitivity to the powder.

Primary placement in Slovenia; available across 32 countries total.

Trade name

not provided

UDI-DI code

+D05800001954SMLB10

Basic UDI-DI

++D058CCDISKZR2AGC

Reference / catalog number

REF 1954SMLB1

Issuing entity

HIBCC

Risk category

Class IIa

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

CC DISK Zr SMILE MULTILAYER B1, 18 mm

Additional information URL

https://interdent.si/f/docs/Download/Interdent-Navodilo-2469-CCDiscZrHTMultilayer-2021-03-25-V35.pdf

Clinical sizes

No clinical sizes registered for this device.

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

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