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Safety Proven 0120 CE 0120 QUALITY CONTROL - CCQ NIOM CERTIFIED FDA APPROVED Scandinavian Institute of Dental Materials All Aalba Dent alloys and solders are At Aalba Dent there is no step more copper. Once these exotic ingredients The European harmonized system for important than Quality Control. Our reach Aalba Dent, every element is the assessment of conformity under stringent quality control process guarantees batch to batch consistency and allows Aalba Dent to deliver the reliability demanded by quality dental laboratories worldwide. Aalba Dent is in perpetual search of the best ingredients. Our nickel, produced via the carbonyl process, checked to certify individual purity before entering the process to become Aalba Dent-approved dental alloys. Products designated with the CCQ mark are certified by Aalba Dent as continuous cast products from our proprietary state-of-the-art continuous casting technology. Products produced Aalba Dent's NIOM-Certified materials the Medical Device Directive (MDD) fulfill the requirements of specific requires all Class IIa medical devices international standards (ISO), further marketed in the European Union (EU) guaranteeing your patient's safety and to have CE marking. Under the satisfaction. The research activities at Directive 93/42/ECC the notifying body SGS has determined select Aalba Dent casting alloys and soldering products to be in compli- has the lowest metallic impurity from this process exhibit unparalleled ance. Medical devices used in content of any commercial nickel. We homogeneity, precise alloy chemistry dentistry, assessed by SGS to be in select premium electrolytic cobalt, high and lower gas content. the MDD, may be marketed throughout the EU and the other countries that are signatories of the European NIOM are internationally recognized, and the institute collaborates worldwide with research institutes in the field of dentistry, medicine and registered and in accordance with the provisions of the Federal Food & Drug (FDA) Cosmetic Act. The act includes requirements for annual registration, listing of devices, good manufacturing practices and labeling. All Aalba Dent restorative devices have been and Drug Administration under the reviewed and approved for marketing requirements of the 1976 Medical clearance by the United States Food Device Amendments Act. conformity with the requirements of Economic Area agreement (EEA). materials science. purity chromium, and OFC high-purity 6 7