Dental Direkt DD Bio CW Notice D'utilisation page 6

EN ENGLISH
Safety instructions
• Cobalt-Chrome-based alloys can seldom cause dermatitis on sensitive subjects. A Patch-Test is thus advisable.
• Metal dusts and fumes are dangerous for health. Use an adequate exhaust fans during milling and polishing.
• The alloy contains Cobalt, element classified as CMR (CAS Number: 7440-48-4).
• Before prosthesis application verify if other metal elements are in patient's oral cavity. Coexistence of different metals can cause a "pile" effect.
• We identify every batch with a number. We recommend to write it down in patient's file to allow its complete traceability.
• This product does not need any special preservation precautions. MESA keeps batch traceability for 15 years.
• The methods of preserving the products made with DD Bio CW are under the responsibility of professional operators (dental technicians).
This product must be stored, transported and used at a temperature between -30°C and +50°C to ensure the integrity of the packaging and
the instructions contained therein.
• MESA recommends that the patient be made aware of the possibility for dental alloys to affect MRI results.
• The product is sold non-sterile.
Users shall report any major accident occurred in relation to the use of this medical device to the manufacturer and the competent authority
of the Member State in which the user and/or patient is established.
A summary of safety and clinical performance (SSCP) is available on Eudamed.
Percentage chemical composition (m/m)
Co
Cr
Mo
Others: Si, Mn
Physical and mechanical properties
Density
Solidus-liquidus temperature
Melting point
Yield load strength (Rp 0.2)
Percentage elongation at fracture
Modulus of elasticity
Vickers hardness
Colour
Thermal expansion coefficient 25-500°C
Thermal expansion coefficient 25-600°C
Maximum firing temperature
Suggested ceramics
Cytotoxicity test according to to ISO 10993-5
Dental Direkt GmbH · Industriezentrum 106 – 108 · 32139 Spenge · Germany · Tel.: +49 5225 863190
eIFU_DD Bio CW_Rev.01_20240104
Instructions for Use
DD Bio CW
66
27
6
8.4 g/cmc
1307-1417°C
1470°C
395 MPa
11%
233 GPa
255 HV10
White
K
14.3·10 -6 -1
14.5·10 K
-6 -1
980°C
VITA VM13
Passed
Symbol Description
Manufacturer
Date of manufacture
Distributor
CE Marking
LOT Batch number
Catalogue number
REF
Non-sterile
50°C
+
Temperature limitation
-30°C
Consult instructions for use
www.dentaldirekt.de/en/IFU
Medical device
UDI
Product UDI Code
Contains hazardous substances
Mesa Italia S.r.L. via dell'Artigianato, 35/37, 25039 Travagliato (BS) ITALIA
6
0425