VITA medical devices Certificates CE marking

VITA medical devices
Certificates
CE marking
VITA Zahnfabrik H. Rauter GmbH & Co. KG . Postfach 1338 . D-79704 Bad Säckingen
Tel. +49 (0) 77 61 562-0 . Fax +49 (0) 77 61 562-299
http://www.vita-zahnfabrik.com . [email protected]
CE marking on VITA medical devices
The enclosed product
group overviews show
which of our medical
devices have the
marking
(identification
number used by notified
body).
These are Class IIa medical
devices.
The CE marking on Class I
medical devices is the
sole responsibility of the
manufacturer, therefore
there is no notified body
identification
number
after the CE.
Depending on the risk they
pose, medical devices are
divided into one of four
classes I, IIa, IIb und III.
Our notified body, DEKRA
Certification, issued the
following certificates:
1. Certificate of quality
assurance in compliance
with EN ISO 9001 /
12.2000 and EN ISO
13485 / 07.2003
2. Certificate confirming
that
the
quality
assurance
system
complies with Appendix
II, Section 3 of Council
Directive 93/42/EWG of
June 14, 1993 on medical
devices
By CE marking our products,
we the manufacturer are
certifying that they conform
entirely to legal requirements.
A conformity assessment
procedure is used to check
that all requirements have
been met.
All VITA products not
listed in the overview are
auxiliary materials (brushes,
interspace varnish, etc.),
which never have a CE
marking.
What does the CE marking signify?
CE signifies that a product
conforms to European
laws, meaning it meets all
the legal requirements of
such a product.
The essential
requirements are:
•Manufacture of product in
such a way to ensure that
it is safe
CE signifies that a product
conforms to European laws,
meaning it meets all the
legal requirements of such a
product.
•High degree of technical
safety ensured by meeting
chemical and physical
requirements
(e.g.
manufacture according to
ISO standards)
To comply with Council
Directive 93/42/EWG and
the Medizinproduktegesetz
(German medical devices
law which implements the
Directive), the manufacturer
must present to the notified
body product documentation
proving that all the essential
requirements
pertaining
to the sale and use of the
products have been met.
•Risk management (risk/
benefit analysis, conformity
to standards, continuous
assessment)
• Biocompatibility
•Clinical assessment
•Continuous monitoring of
marketed goods (reporting
of incidents, safety plan)
By CE marking its products,
the manufacturer certifies
that they conform entirely
to legal requirements, thus
enabling the free movement
of goods on the EU internal
market.
At the same time, the CE
marking reduces the amount
of necessary documents and
certificates to the absolute
minimum.
At the same time, the CE
marking reduces the amount
of necessary documents and
certificates to the absolute
minimum.
From a legal point of view,
a dental laboratory is a
manufacturer of custommade
medical
devices.
Although
its
quality
management system does
not by law have to be certified
according to EN ISO 9001 and
EN ISO 13485, it must provide
documentation for every
custom-made device (metal,
metal ceramic, all-ceramic
and acrylic crowns, bridges,
inlays, etc.) stipulating
•All materials used (e.g.
alloys, dental ceramic
materials)
•All manufacturing stages
and
processes
(see
Appendices I and VIII of
Council Directive 93/42/
EWG)
The simplest way of
proving that the essential
requirements (see Appendix
I of Directive 93/42/EWG)
pertaining to the dental
restoration have been met is
to use medical devices with
a CE marking.
Overview of medical devices
VITA all-ceramics
VITA In-Ceram
VITA In-Ceram
slip technique
VITA In-Ceram
MC material
VITA In-Ceram SPINELL
(CE 0124)
VITA In-Ceram SPINELL
(CE 0124)
VITA In-Ceram ALUMINA
(CE 0124)
VITA In-Ceram ALUMINA
(CE 0124)
VITA In-Ceram ZIRCONIA
(CE 0124)
VITA In-Ceram ZIRCONIA
(CE 0124)
VITA machinable
polymers
VITABLOCS
VITABLOCS Mark II
(CE 0124)
VITA In-Ceram
accessories
Coloring Liquid
(CE 0124)
Vitablocs
accessories
VITABLOCS ESTHETIC LINE
(CE 0124)
CERECPropellant,
powder + piquid (CE)
VITA Luting Set
(Coltene CE 0123 and CE 0124)
VITA CAD-Waxx
VITABLOCS TriLuxe
(CE 0124)
VITA Ceramics Etch
(not a medical device)
VITA Etchant Gel
(Coltene CE 0123)
VITA teeth
VITA equipment
VITA In-Ceram YZ
(CE 0124)
VITA In-Ceram AL
(CE 0124)
Clinical products
Oxyprevent
(CE 0124)
Acrylic teeth
Ceramic teeth
VITAPAN
(CE 0124)
VITA LUMIN VACUUM
(CE 0124)
Teeth accessories
VITACOLL bonding agent
(CE 0124)
VITA PHYSIODENS
(CE 0124)
VITAFOL H silicone insulating film
(CE 0124)
VITA TRIOSTAT
(CE 0124)
Impression trays
(CE)
VITA vacuum equipment
VITA atmospheric equipment
(not a medical device)
(not a medical device)
VITA VACUMAT 4000
PREMIUM T
VITA VACUMAT 40 T
VITA ZYrcomat
VITA ATMOMAT
Shade determination
VITA Easyshade
(CE)
Toothguide
(not a medical device)
VITA A.R.T. Bond
(Coltene CE 0123)
VITA Duo Cement
(Coltene CE 0123)
Vitasil
(CE 0124)
VITA INCERAMAT 3T
VITA DUOSTAT
(CE 0124)
VITA SICCOTHERM
VITA LUMIN ACRYL V
(CE 0124)
VITASONIC
Veneering materials
Metal ceramics
All-ceramics
Ceramic accessories
Veneering acrylics
VITA OMEGA 900
(CE 0124)
VITA RESPONSE
(CE 0124)
VITA VM 7
(CE 0124)
Ceramic stains
(Akzent, Interno, shading Paste)
(CE 0124)
VITA METALL CORRECTOR SET
(CE 0124)
VITA VM LC
(CE0124)
VITA ZETA LC COMPOSITE
(CE 0124)
VITA OMEGA
(CE 0124)
VITA TITANKERAMIK
(CE 0124)
VITA VM 9
(CE 0124)
VITA SPRAY-ON
2000 3D-MASTER
(not a medical device)
Modeling liquids
(not a medical device)
VITA VM BOND
(CE0124)
VITA ZETA CC POLYMER
(CE 0124)
VITA VMK 95
(CE 0124)
VITA VM 13
(CE 0124)
VITADUR ALPHA
(CE 0124)
VITA Modisol
(not a medical device)
VITA ZETA HC COMPOSITE
(CE 0124)
VITA ZETA HLC BOND
(CE 0124)
Veneering acrylic
accessories
Modeling liquids
(not a medical device)
866D - 0706 (1.) Si
VITA Zahnfabrik H. Rauter GmbH & Co. KG . Postfach 1338 . D-79704 Bad Säckingen
Tel. +49 (0) 77 61 562-0 . Fax +49 (0) 77 61 562-299
http://www.vita-zahnfabrik.com . [email protected]