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SPECIFICATION SP A118/4

KAVITAN PLUS

Set: 3
Revision: 2

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.

Page 1 of 2

Set: 3

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

Tested according to:


ZP 3113250
ZP 3113250
ZP 3113250
ZP 3113250
ZP 3113250
ZP 3113250
ZP 3113250
ZP 3113250
ZP 3113250
ZP 3113250
ZP 3113250

4.6 Storage Conditions


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

Pages
3+2
3+2

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

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