Download SPECIFICATION SP G106 SPOFACRYL Set: 3 Revision: 2

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