DOCUMENTATION SPECIFICATION SP A130 Set No.

3
DEPT. SUPER-COR Revision: 1
SpofaDental a.s.

1. Purpose
The purpose of this specification is to determine the conditions which must be fulfilled by
Super-Cor universal light-cured microhybrid composite 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
Super-Cor is a light-cured microhybrid composite for the restorative treatment of anterior and
posterior teeth. All shades but incisal are radio-opaque. It comes in contact with human
tissues.

3. Abbreviations
JJ .................... Quality Assurance
JKJ.................. Quality Assurance and Quality Control
OKJ ................ Quality Assurance Department
OVD .............. Internal Documentation Department
PVJ ................ Quality Management Representative
SOP ................ Standard Operation Procedure
SP .................. Specification
ZP .................. Test Procedure

4. Description

4.1 Product Name
Super-Cor
Universal light-cured microhybrid composite

4.2 Material Form
Super-Cor, composite material in paste form in all VITA shades and universal opaque and
incisal shade.

4.3 Package Size and Description
INTRO KIT:
5 x 5 g of paste Super-Cor in a syringe in VITA shades A1, A2, A3, A3.5, C2
1 x 3,5 g Etching gel with 10 tips
1 x 2 g of paste Opticor Flow composite, shade A2 in a syringe with 10 tips
1 x 5 ml of Retensin Plus adhesive
Together with 25 applicator brushes, 25 mixing wells and direction for use it is placed into the
box with paper cover.

Super-Cor refill:
1 x 5 g of paste Super-Cor in a syringe (All 16 classic VITA shades + universal opaque) in
PE packing with direction for use
1 x 2,5 g of paste Super-Cor in a syringe in incisal shade in PE packing with direction for use

DOCUMENTATION SPECIFICATION SP A130 Set No. 3
DEPT. SUPER-COR Revision: 1
SpofaDental a.s.


4.4 Collection of Samples: According to SOP 10-107, par. 5.1.

4.4.1 Number of counter-samples: 2 filled syringes of each manufactured batch

4.5 The Product Must Conform to the Following Requirements

4.5.1 Contents of the package
INTRO KIT:
5 x 5 g of paste Super-Cor in VITA shades A1, A2, A3, A3.5, C2: min. 5 x 4,55 g,
1 x 2 g of paste Opticor Flow composite: min. 1,82 g,
1 x 5 ml of Retensin Plus adhesive: min. 4,55 g,
3,5 g of Etching Gel: min. 3,19 g.

Doplkov balen:
1 x 5g of paste Super-Cor (All 16 classic VITA shades + universal opaque): min. 4,55 g.
1 x 2,5 g of paste Super-Cor in incisal shade: min. 2,28 g


4.5.2 Statistical product check: Conforms to SOP 10-107.

4.5.3 Other parameters

Tested property Theory Tested according to:
Appearance Homogeneous without
contamination
Declared by Kerr
Colour Match with Vita Porcelain Declared by Kerr
Translucency 35,0 - 42,0 % Declared by Kerr
Hardness Rockwell 78 Declared by Kerr
Diametral Strenght 8000 psi Declared by Kerr
Polymerization, 10 sec. polim. 3,4 mm Declared by Kerr
Fluorescency Presence of fluorescence Declared by Kerr
No. of voids 10 voids/cm2 Declared by Kerr
Slump 1,9 - 2,2 cm Declared by Kerr
Lab working time 50 s Declared by Kerr

4.6 Storage Conditions: Store at temperature from 5C to 23C, in a well sealed package.

4.7 Shelf Life: 3 years (refill package)
2 years (INTRO KIT package)
DOCUMENTATION SPECIFICATION SP A130 Set No. 3
DEPT. SUPER-COR Revision: 1
SpofaDental a.s.


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
SN EN ISO 4049 Dentistry Filling, Reconstruction and Fixation Polymeric Materials
SP A128 Opticor Flow
SP A108/2 Etching Gel
Kerr internal standards


6. Revisions

Modifications to this specification are provided by the JKJ Manager according to SOP 5-101.

6.1 Revision Procedure
Chapter No. Description Pages Revision Date of issue
- Storage conditions, type of
package, full text of SP A130
(functions, distribution list)
3 + 2 1

7. Appendices

Appendix 1 Composition of Super-Cor


This specification replaces: -

Name and Surname, position Signature Date
Prepared by: Petr Tobolka, OVD, Officer 15.06.2010
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