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SPECIFICATION SP G106 SPOFACRYL Set: 3 Revision: 2 1. Purpose The purpose of this specification is to determine the conditions which must be fulfilled by Spofacryl a self-curing adhesive dental resin - before releasing it for despatch. This specification is one of the registration documents and is used as a reference document when contacting the purchasers. 2. Product Characteristics Spofacryl, a self-curing adhesive dental resin, is used in dentistry mainly for repairs of loose facets from crowns and bridges, for bonding adhesion bridges and fixed splints to an etched enamel, for bonding orthodontic brackets for fixed appliances. It has a long term effect in the patient’s mouth. 3. Abbreviations JJ ……………… JKJ ..................... OKJ ....…..…….. OVD .................. PE …………… PVJ .................... SOP ................... SP ...................... ZP ...................... Quality Assurance Quality Assurance and Quality Control Quality Control Department Documentation Department Polyethylene Quality Assurance and Control Section Standard Operational Procedure Specification Testing Procedure 4. Description 4.1 Product Name SPOFACRYL self-curing adhesive dental resin 4.2 Material Form Spofacryl powder is a fine powder, stable in air, in colour shade system similar to VITA A2, A3.5, B3, C2 and 0. Spofacryl liquid is a transparent, clear to light yellow liquid, with a typical odour. 4.3 Package Size and Type Spofacryl 100 g: 100 g of powder in colour shade system similar to VITA: A2, A3.5, B3, C2 and 0 in a PE container with a cap and 100 g of liquid in a glass bottle. All packed together in a folded paper box with 10 caps and an instruction sheet (user’s guide). 4.4 Collection of Samples: According to SOP 10-107, par. 5.1. 4.4.1 Number of counter-samples: ca 100 g from each finished product batch 4.5 The Product Must Conform to the Following Requirements 4.5.1 Contents of the package Spofacryl 100 g: 100 g of powder in colour shade VITA A2, A3.5, B3, C2 and 0: min. 95,50 g 100 g of liquid: min. 95,50 g 4.5.2 Statistical product check: Conforms to SOP 10-107. Appendix 2 SOP 05-101, rev. 2 Specification of finished product Rules for preparation of controlled documentation Level III Page 1 / 2 Set: 3 SPECIFICATION SP G106 SPOFACRYL 4.5.3 Other parameters Tested property Setting time Brinell hardness Appearance and colour of sample Porosity Surface Absorbability Solubility Transparency and colour of liquid Theory max. 10 min min. 120 MPa conforms conforms conforms max. 32 µg/mm3 max. 8 µg/mm3 conforms Revision: 2 Tested according to: ZP 3318300 / ZP 4318200 ZP 185342 ZP 185342 ZP 185342 ZP 185342 ZP 185342 ZP 185342 ZP 3318300 4.6 Storage Conditions To be stored in a dry and dark place at temperatures of 5-25 °C, in a well sealed package. 4.7 Expiry Period 3 years 5. Related Documents SOP 05-101 Rules for preparation of controlled documentation Level III. SOP 10-107 Rules for statistical check of products placed in inner packaging and for statistical check of finished products ZP 185342 Resin D1 120 ZP 3318300 Spofacryl liq. ZP 4318200 Spofacryl 100 g O 6. Revisions Modifications to this specification are provided by the JKJ Manager according to SOP 05-101. 6.1 Review of Modifications Chapter Description Pages Revision No. Colour shades, package contents, parameters, raw 2+2 1 materials - Updated art. 3 and 4.4.1., change of related documents and distribution list. Deleted art. 4.4.2. Stated composition, modified some names of input articles. Name and Surname, position Prepared by: Petr Tobolka, OVD Officer 3+2 Signature 2 Effective from 8.11.2006 the date of issue Date 8.12.2014 Approved by: Jaroslav Adolf, JKJ Manager Released by: Jaroslav Adolf, PVJ Issued by: Petr Tobolka, OVD Officer In effect from: the date of issue Appendix 2 SOP 05-101, rev. 2 Specification of finished product Rules for preparation of controlled documentation Level III Page 2 / 2