technical data sheet: cotton star rolls® ftas32-001 - New Stetic

TECHNICAL DATA SHEET: COTTON STAR ROLLS®FTAS32-0011. GENERALITIESCotton for dental use is manufactured from Cotton Noils. This fiber is composed of88 –96% cellulose.Cotton Noils is washed with cleansing and softening solution and is then subjectedto specific temperatures, to eliminate all dirt or impurities. Afterwards, openingprocess is done preparing it for the drying process. Once dried, it is subject to thecarding process that consists of aligning and combing the cotton fibers and then itis softened depending on the programmed final presentation.Cotton for dental use manufactured by New Stetic is not washed with chlorinecomponents nor does it have optical whitening additives.2. COMPOSITIONCotton Noils 100%.3. PROPERTIES3.1 BIOLOGICAL PROPERTIES• Does not provoke allergic reactions and because of its softness does notharm or irritate mucous membranes.• Absence of pathogenic microorganisms.3.2 CLINICAL PROPERTIES• Of easy manipulation without loosening fiber while used, it does not adhereto mucous membranes.• Good capacity of absorption of oral fluids, increasing its working time,reducing the number of replacements and facilitating the dentist’s workingtime during the treatment.3.3 PHYSICAL AND CHEMICAL PROPERTIES• Insoluble in organic fluids (chemical stability).• pH close to neutral.Elaboración: 2010-08-20Modificación: 2013-09-03Elaborador: Analista Gestión tecnol.Aprobador: Jefe Dpto. Diseño y Dllo.ClaseEPágina1 de 1

TECHNICAL DATA SHEET: COTTON STAR ROLLS®FTAS32-0014. USE AND APPLICATIONSCotton for dental use is used mainly both to absorb oral fluids facilitating the workdone by the dentist in the patient’s mouth and to retract the cheek while absorbingthe humidity.The application of cotton for dental use is in the dental field where it is required towork in the minimum conditions of possible humidity.5. PRODUCT QUALITY ASSURANCECotton for dental use is manufactured with high quality raw materials, through astandardized process and certified under the ISO 9001 and ISO 13485 standards.In addition, in the Quality Control Laboratory it is verified that the finished productof cotton for dental use is in compliance with the quality requirements of the 2000British Pharmacopoeia and the Decree number 677 of 1995 from the Ministry ofHealth of the Republic of Colombia.The parameters that are evaluated verify that the cotton:- Shows good absorption.- Has a neutral pH suitable for its use.- Is free of pathogenic microorganisms.6. USE INSTRUCTIONSCotton for dental use should be handled following all the stipulated hygienerequirements for dental procedures in which it is used. Basically the handlingprocess is the following:• Dispense the cotton from its original packing using a cotton tweezer.• With the cotton tweezer hold the cotton and place it into the patient’s mouth inthe desired location.• Once the dental procedure is finished, throw it away immediately.Elaboración: 2010-08-20Modificación: 2013-09-03Elaborador: Analista Gestión tecnol.Aprobador: Jefe Dpto. Diseño y Dllo.ClaseEPágina2 de 2

TECHNICAL DATA SHEET: COTTON STAR ROLLS®FTAS32-001• This material is not reusable.7. COMMERCIAL PRESENTATIONS7.1 Plain and BraidedBox x 2000 rolls, master box 20 BoxesBag x 500 rolls y 1000 rolls , master box 45 BagsThe bag is made of low density polyethylene.The box is made of Kraft and Cream 127 paper.7.2 BallsBag x 5 g, 10 g, 50 g, 100 g and 500 g.The bag is made of clear low density polyethylene.7.3 Zig ZagBag x 25 gramsBag x 50 gramsBag x 100 gramsBag x 250 gramsPound x 454 gramsThe bag is made of low density polyethylene.8. PACKING MATERIALAll the packing materials used in the product cotton for dental use are completelycompatible with the product, preserving at the same time its quality characteristics.9. EXPIRATION DATEIt is not required by Colombian regulation.Elaboración: 2010-08-20Modificación: 2013-09-03Elaborador: Analista Gestión tecnol.Aprobador: Jefe Dpto. Diseño y Dllo.ClaseEPágina3 de 3

TECHNICAL DATA SHEET: COTTON STAR ROLLS®FTAS32-00110. STORAGE AND CONSERVATION MEASURESStore is cool, dry place away from sources of ignition. Keep the product inside thepackaging.Elaboración: 2010-08-20Modificación: 2013-09-03Elaborador: Analista Gestión tecnol.Aprobador: Jefe Dpto. Diseño y Dllo.ClaseEPágina4 de 4