Medizinprodukte

Medical Products

are all instruments, appliances, devices, software, substances and preparations from substances or other items that are intended to be used for people to identify, prevent, monitor, treat or alleviate illnesses.

Council Directive 93/42/EEC

The Medical Device Directive (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, OJ No L 169/1 of 1993-07-12) is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the requirements of the MD Directive have to be met. Manufacturers' products meeting 'harmonised standards' have a presumption of conformity to the Directive. Products conforming with the MD Directive must have a CE mark applied. The Directive was most recently reviewed and amended by the 2007/47/EC and a number of changes were made. Compliance with the revised directive became mandatory on March 21, 2010. 

1. Section 3 of the Medical Devices Act no. 1 to 4 legal definition/en of the term. 
2. The following classifications have no claim to completeness.
3. Appendix IX of the Directive 93/42/EEC contains the legal classification for medical devices in the EU.

Classification

Based on the applicable statutory requirements for medical devices the manufacturers assign each of these to a certain class. In so doing, a distinction is made based on the Directive 93/42 EEC Appendix IX of the Medical Device Directive (MDD) between four classes that also imply different requirements for access to market. The criteria duration and invasiveness of the application, application site, and the feature active/not active plays a role.

MediProdukt Kl. 1

MedProduct Cl. 1

low risk

Generally all non-invasive products, products applied in the short term under certain conditions, low potential risk, such as impression making masses, bite registrations have a role to play

MediProdukt Kl. 2a

MedProduct Cl. 2a

medium risk

Generally invasive products with a short-term application, invasive products with a long-term application under certain conditions, medium potential risk, such as materials for the manufacture of otoplastics, protheses lining material, fissure sealant material, dental prosthesis

MediProdukt Kl. 2b

MedProduct Cl. 2b

high risk

Generally all implantable products, products with increased methodical potential risk, such as disinfection agents

MediProdukt Kl. 3

MedProduct Cl. 3

very high risk

Products with very high potential risk, e.g. application for the heart, central nervous or circulation system, development of a biological effect

 
VDDI
mdc Zertifiziert
DIN Normen Ausschuss
DIN Normen Ausschuss
 

Regulatory Affairs regulatory.affairs@detax.de 
Phone +49 7243 - 510-132
Fax +49 7243 - 510-221

DETAX MediGuide
medi.guide@detax.de
Phone +49 7243 - 510-226
Fax +49 7243 - 510-222

Qualified Person
medical devices
QP.medical.devices@detax.de
Phone +49 7243 - 510-243
Fax +49 7243 - 510-222

 
 
MediGuide

DETAX MEDI GUIDE

We are happy to advise you on all questions about medical devices.

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CERTIFICATION

CERTIFICATION

Certified according to the latest standards and directives on medical devices.

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DETAX Logo
DETAX Logo
 

Welcome at DETAX online – Your specialists for medical material.

For over 60 years, we have been developing silicones and light-curing resins for dental and other medical applications. The polymer chemistry of materials is our universe.

DETAX GmbH & Co. KG
Carl-Zeiss-Str. 4
76275 Ettlingen
Germany

Phone +49 7243 / 510-0
Fax +49 7243 / 510-100 
post@detax.de

 


BRAND PRODUCTS DENTAL: Molloplast® B · implantlink semi® · mollosil® · mollosil® plus · Detaseal® hydroflow · Detaseal® hydroflow Xlite · Detaseal® antilock · Detaseal® soft2putty · Detaseal® function · smartprotect® · smartprotect® soft· smartseal® cervi · smartrepair® · smartfluorid® · silasoft® · silaplast · sta seal f · Fermin · tempofill® · tempofit® · Permaliner · pixelbite · milkbite · Detaseal® bite · glassbite · greenbite® colour · greenbite® apple · monoprint supra · onetime perfect · Lustrol® · Drala® · Cavidex®  · easyform · blue eco · blue eco scan® · Flexistone® · Gingivamoll® · Implant Mask BRAND PRODUCTS AUDIO: addition ultra® · addition supra® · addition spectra · addition protect · pink mix · detax flextime® · addition mini · aquaplus® · protect mold  · softwear® 2.0  · earflex® rainbow  · earflex® clear · earflex® rose · bioplast · direct mold · aqua coat · frosty coat · super coat · microporlack · durosil® · duglasil® · duglasil® express · acrylon® · smartclean® foam · smartclean® tabs · smartclean® pen · smartclean® · smartcare® BRAND PRODUCTS 3D:  luxaprint® 3D shell · luxaprint® 3D mould · luxaprint® 3D cast · freeprint® shell · freeprint® mould · freeprint® cast · Cast Separator 2.0 · luxaprint® shellac · luxaprint® shellac color · freeprint® model · freeprint® cast · freeprint® splint · freeprint® ortho · freeprint® c&b

Detax. As a brand, this name stands for high-quality medical devices. For over 60 years, we have been developing silicones and light-curing resins for dental and other medical applications. The polymer chemistry of materials is our universe. Our enthusiasm and innovative strength is ingrained in every one of the products that you will become familiar on this Website.

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We develop hydrophilic impression making silicones for every indication (corrective and double mix technology, kneadable working impression making for functioning rim design, sandwich technology, monophase impression making). Precision impression making materials of lightly flowing consistency with ideal flow characteristics, maximum wetting power, and elastic resilience. Regular set, fast set or super fast set with thermoactive setting characteristics and a defined snap set, kneadable putty, color violet with wildberry flavor. Ear impression making silicones in 50 ml double cartridges specially for IO/CIC changes with lightly flowing starting consistency, even for narrow auditory canals or patients with chronic pain. Ear impression making silicones for children and young people (paediatrics), pressure-less impression, no ingress of soft tissue. Ear impression making material for hearing-protection adjustments, low squeezing pressure, stable, does not run out of the ear, short time in the ear, skin friendly, non adhesive. Highly elastic resilience, easy to remove, 35 Shore A monophase impression making silicone in medium tray consistency. Harmonized consistencies of tray and corrective material. Transfer silicones, quick-setting and clearly transparent A-silicone base bite registration material, medium flow, thixotropic, to be applied directly on the row of teeth, no flowing away into interdental chambers, X-ray transparent matrix material, crystal clear, final hardness 80 Shore A, for light hardening of composites. Scannable VPS bite registration material for the powder-free 3D data acquisition for all CAD/CAM/CIM processes (stripe light projection, laser triangulation and CEREC), 32 Shore D, short time spent in the mouth. Permanently plasticizing relining silicones, direct relining in the dental practice chairside or for processing in the dental laboratory. Broad indication spectrum (obturators and mouth guards) with plaque inhibitors, clinically tested and scientifically documented. Secure bond to prosthetic acrylate. Additional crosslinking duplicating silicones and laboratory plasticines 85 Shore A for precasts, control bites, fixing of artificial teeth, models for prosthetic repairs. Permanently elastic otoplastic silicone, buoyant, direct fitting of water plugs and ear canal plastics, for the indirect manufacture of soft HdO and protective plastics, for PNP, 3D cast technology, permanently keeps its color. Even with extended processing time for series manufacture in the obtoplastics laboratory. Air-drying silicone paint for water plug plastics antibacterial with silver particles. Bis-acrylic composite 10.1 for temporary crowns, bridges and long-term temporaries with elastic phase and maximum and flexural and abrasion resistances, low polymerization temperature, translucent colors: A1, A2, A3, A3,5. Composite-based fissure sealant with wet bonding technology. Protective lacquer for exposed root dentine with high degree of cross-linking based on multifunctional (meth)acrylate has a desensitizing effect, forms a barrier against erosion, thereby reducing cervical sensitivity. Transparent fluoride varnish with amino-fluoride, mouth wash. Flexible gum masks for dental master and saw models, dimensionally stable, for a naturally aesthetic gingival look in tubes or cartridges. Dental cements for definitive and semi-permanent implantation, fasteners, long-term temporary fixing cements, plastic-based radio-opaque, cementation of supra-constructions, dual hardener system. Ready-to-use modeling resin, as a gel or paste, MMA-free, combustible without resins, no polymerization shrinkage. Gum epithesis material, hot curing. Kneable UV plastics for manufacturing biocompatible splints & templates. Plastics for 3D print systems: dentistry models, casting objects, IIa-class clear transparent resins for biocompatible implant templates and splints, KFO (DIN) base parts, long-term temporary K&B composite and supplies in total prosthodontics

© 2017, DETAX Ettlingen, Germany