Expansion screws for every application.
EN
EN
CONTEC
The secure connection.
Free of
BisGMA*
TEGDMA*
HEMA*!
CertiFiCate
Metal brackets.
acrylics for orthodontic appliances
Expansion screws.
Perfect in form, function and design.
tests on the biocompatibility of
The following test procedures were used to determine the biocompatibility of Orthocryl® in all colors
and forms of presentation:
Test for cytotoxicity (DIN EN ISO 10993-5)
The test serves to evaluate the proliferation of the connective tissue cells L-929.
Test for the irritating effect to the mucosa (HET-CAM Test)
DEDE
The so-called HET-CAM test was used to determine irritant properties for the mucosa.
Test for mutagenicity (Ames test)
The Ames test is a screening test employed worldwide that uses bacterial strains to test for genetic mutations.
The tests department
were for carried hygiene out by and K. U.medical Schendel,microbiology L. Erdinger,at G.Heidelberg Komposch,University H.-G. Hospital.
Sonntag, Polyclinic for orthodontics and the The tests are recognized by official bodies (DIN EN ISO, BfR, MDC) for the testing of medical products with
non-animal testing procedures.
The acrylic was tested in polymerized form, which is the form used for patients.
Conclusion:
In the above-mentioned tests, Orthocryl® displayed no properties that were toxic, irritating to the mucosa
or mutagenic.
tests on the biocompatibility of
Orthocryl® LC does not contain methyl methacrylate, or dibenzoyl peroxide or bisphenol-A and is therefore
an anti-allergenic and environmentally friendly alternative to conventional self(cold)-curing acrylic
for orthodontic appliances.
The toxicological
accredited tests:
test laboratory MDS (www.mdservices.de) submitted Orthocryl® LC to the following A cytotoxicity test acc. to DIN EN ISO 10993-5 (elution time 7d).
A chemical analysis of eluted components acc. to DIN EN ISO 10993-12.
A biological evaluation of existing documents and results acc. to DIN EN ISO 10993-1.
Since the vapor pressure is very low for the monomers in use, the dental technician is subjected to much
lower levels of odor pollution.
all Orthocryl®/Orthocryl® lC products are approved as medical products
for Class iia for long-term use in the mouth (> 30 days).
989-301-05 Printed by Dentaurum Germany 05/17
Turnstr. 31 I 75228 Ispringen I Germany I Telefon + 49 72 31 / 803 - 0 I Fax + 49 72 31 / 803 - 295
989-301-05_Orthocryl_LC_Zertifikat_0517.indd 1 www.dentaurum.com I info@dentaurum.com
16.05.17 08:04
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passion and
precision.
temporary
orthodontic
micro
anchorage
system
Palatal expansion.
Skeletal and dentoalveolar anchorage.
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Edition 23
Orthodontics Catalog
Gebrauchsanweisung I Instructions for use I
Mode d’emploi I Modo de empleo I Modalità d‘uso
Schraube I Screw I Vis I Tornillo I Vite
IN