1. Purpose The purpose of this specification is to determine the conditions which must be fulfilled by Kavitan Plus a radiopaque glass ionomer cement - 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 Kavitan Plus is a radiopaque glass ionomer cement which is used in dentistry as a base, liner and filling material. It has a long term effect in the treated tooth. 3. Abbreviations MJKJ OKJ OVD PVJ SOP SP ZP
Quality Assurance and Control Manager
Quality Control Department Internal Documentation Department Quality Management Representative standard operation procedure specification test procedure
4. Description 4.1 Product Name KAVITAN PLUS radiopaque glass ionomer cement 4.2 Material Form, Shades Kavitan Plus powder is a fine powder, free from mechanical impurity, in shades A2, A3, B1, B3 and C3 according to the VITA shade guide. Kavitan Plus liquid is a lightly yellowish, clear, viscous liquid. 4.3 Package Size and Description Kavitan Plus standard package: 15 gr. of powder in shade A2, A3, B1, B3 or C3 in a labelled glass vial, and 15 gr. of the liquid in a labelled PE container, mixing pad, scoop, instruction sheet (users guide). All enclosed in a folded paper box. Kavitan Plus plv. 15 gr.: 15 gr. of powder in shade A2 or A3 in a labelled glass vial in a folded paper box with an instruction sheet (users guide). Kavitan Plus liq. 15 gr.: 15 gr. of liquid in a labelled PE container in a folded paper box with an instruction sheet (users guide). 4.4 Collection of Samples: According to SOP 10-107, par. 5.1. 4.4.1 Number of counter-samples 1 packaging unit of the semi-batch 4.5 The Product Must Conform to the Following Requirements 4.5.1 Contents of the original package Kavitan Plus standard package: 15 gr. powder in shade A2, A3, B1, B3 or C3: min. 13.65 gr. 15 gr. liquid: min. 13.65 gr.
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SPECIFICATION SP A118/4 KAVITAN PLUS
Revision: 2 Kavitan Plus plv. 15 gr.: 15 gr. of powder in shade A2 or A3: min. 13,65 gr. Kavitan Plus liq. 15 gr.: 15 gr. of liquid: min. 13,65 gr. 4.5.2 Statistical product check Conforms to SOP 10-107. 4.5.3 Other parameters Tested property Consistency (1.35 gr. plv/0.5 gr. liq.) Setting time Working time Compression strength Disintegration Count of particles > 30 m Drying loss Refraction test at 37.0 C Mean diameter Delta E Opacity
Theory 26.0 33.0 mm 2.50 4.50 min. min. 120 sec. min. 160 MPa max. 200 S/cm gr. max. 0.4 % max. 0.5 % max. 10 min. from the start of mixing 5.5 6.5 max. 2.0 0.35 0.90
To be stored in a dry and dark place at 525 C, in a well sealed package. 4.7 Shelf Life 3 years 5. Related Documents SOP 05-101 SOP 10-107 ZP 3113250 ZP 3113251 SN EN ISO 9917
Rules for preparation of controlled documentation Level III.
Rules for statistical check of products placed in inner packaging and for statistical check of finished products Kavitan Plus powder, clear Kavitan Plus coloured A2 Water-setting Dental Cements
6. Revisions Modifications to this specification are provided by the MJKJ according to SOP 05-101. 6.1 Revision Procedure Chapter No. Description Package content, shelf life, raw materials Packaging, testing, documentation, distribution list, abbreviations, contents. Name and Surname, position Prepared by: Petr Tobolka, OVD Officer
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Signature
Revision 1 2
Date of issue 12.6.2006
Date 5.4.2011
Approved by: Mgr. Jaroslav Adolf, JKJ Manager
Released by: Mgr. Jaroslav Adolf, PVJ Issued by: Petr Tobolka, OVD Officer In effect from: the date of issue
