DENTAL POLISHING DISCS AND MANDRELS
Polishing discs (Basic UDI-DI 463003499POLDISDH)
##1.021, 1.069, 1.07* series, 1.73* series, 2.07* series, 2.73* series, 9.73* series, 10.73* series
Stem polishing discs (Basic UDI-DI 463003499POLDISDH)
##1.020, 1.6** series, 1.76* series, 9.6** series, 9.76* series, 11.6** series
Mandrels (Basic UDI-DI 463003499MNDDISA7)
##1.110, 1.111, 1.113, 1.115, 1.120, 1.121, 1.121(3), 1.122
INSTRUCTION FOR USE
Revision 14
Revised August 22, 2025
Reason for revision: alignment with (EU) 2021/2226 Regulation requirements
Name of manufacturer
TOR VM Ltd.
Registered trade mark of manufacturer
Address of manufacturer
Novatorov street, 7A, bld.2, room 44B, 119421 Moscow, Russia
SRN RU-MF-000016957
Manufacturing site:
Kulibina, 15c, 394029 Voronezh, Russia
General manager: Dr. Oleg Mikhalev
Technical and manufacturing manager: Dr. Mikhail Lesovoy
Tel.: (495) 225 54 17
e-mail: torvm@gmail.com
internet: www.torvm.ru
European representative
Gregor Kostunov
SRN DE-AR-000006585
Untere Seegasse 54, DE-69124 Heidelberg, Germany
Tel/fax (49) 6221718120
E-mail: tor.vm.de@googlemail.com
The products are CE marked
Notified body
SZUTEST Konformitätsbewertungsstelle GmbH
Notified Body number on NANDO: 2975
Address: Friedrich-Ebert-Anlage 36, 60325 Frankfurt am Main, Germany
Tel.: +49 69 244 333 026
E-Mail: info@szutest-germany.de
Trade names and catalogue numbers
See List of Products (see Annex 1)
General description of the device
Polishing discs with metal connector and stem polishing discs with plastic connector (hereinafter discs) and mandrels are used for polishing and finishing of composite fillings.
Coated abrasive discs are made by bonding abrasive particles onto a thin polymer backing. The discs are coated with an aluminum oxide abrasive or synthetic diamond powder. Normally 4 grades of discs are used: coarse, medium, fine, superfine. The range of particle size distributions noted for coated abrasive discs vary from 100 to 50 micrometers for coarse-grade discs to 15 to 2 micrometers for superfine grade of polishing discs. The grade of disc is coded with disc color.
Mandrels are made from high quality stainless steel and are used to transfer rotation from hand piece to polishing disc.
The devices contain no human or animal-derived tissues or cells.
The devices are supplied non-sterile.
Discs are for single use.
Mandrels can be re-used and must be sterilized after each procedure.
Intended purpose
Polishing and stem polishing discs:
1) to polish dental fillings via rotation transferred from dental hand piece manipulated by dentist;
2) to be used by hand manipulation of hand piece around the dent.
Mandrels:
1) to transfer rotation from dental hand piece to the polishing disc;
2) to be used as intermediate (adapter, transition adapter) between polishing discs and headpiece.
Indications
necessity to polish the restoration after hardening of the restorative material:
to remove excess flash and refine the margins of the restoration, providing smooth restoration contacts and more aesthetic, light-reflectant restoration;
to remove excess of filling material from interproximal areas
Contraindications
Non, dental polishing discs and mandrels can be used for all groups of patients without restrictions
Target groups
Dental polishing discs and mandrels are used for all groups of patients without restrictions, including children (population up to 18 years old).
Intended users
Dental polishing discs (discs) are intended for professional use in dental clinic only. Operating with discs is well known procedure. No special training needed.
Harmonised standards and CS applied
Regulation (EU) 2017/745
EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
EN 62366-1:2015/A1:2020 Medical devices – Part 1: Application of usability engineering to medical devices
TU 9391-001-49962851-00 Kits of Dental Polishing Discs of 4 Type of Abrasiveness DSh TOR VM
No incidents, risk-associated cases or non-conformities concerning TOR VM dental polishing discs or equivalent devices have been revealed upon clinical evaluation and clinical post market follow-up study.
Benefits
The main benefits of polishing are:
1. increasing restoration quality and aesthetics,
2. increase restoration service life,
3. reduction of restoration surface roughness,
4. improvement of dentin, composite and ceramics color stability,
5. lowering bacterial adhesion, increasing composite biocompatibility.
Warnings and precautions
1. Do not use discs and mandrels on handpieces intended for speeds exceeding 30000 rpm to avoid the disc or mandrel damage that may lead to an injury.
2. Do not operate mandrel without disc.
3. Avoid contacting of mandrel or disc connector with composite - possible discoloration may require to repeat polishing once more.
4. Use successively discs of all 4 types - otherwise the quality of restoration polishing may be reduced.
5. Control quality of disc surface while operating. Rotational behavior and the appearance of the disc changes 10-15 seconds before separation or break. The visual appearance of the disintegrated disc is changed. Do not use discs with delaminated abrasive coating or damaged polymer part. This may cause tissue damage.
6. Control the cooling air supply during polishing to avoid dentin overheating.
7. Do not use polishing disc once more – discs are single-use device – second use can lead to:
- tissue infection,
- tissue damage caused by delamination of abrasive coating,
- tissue damage by parts of disintegrated disc,
- tissue damage caused by disconnection between disc and mandrel.
8. If package with discs or mandrels is broken or disrupted discs or mandrels prior to use must be sterilized by a standard method.
9. In case of registered accidental contact of device with tooth or soft tissues stop polishing and inspect place of contact for possible damage. In case of soft tissue damage perform corresponding treatment to exclude possible complications
STERILIZATION
Mandrels ##1.110, 1.111, 1.113, 1.115, 1.120, 1.121, 1.121(3), 1.122
Mandrels are sterilized after each patient using conventional steam autoclave at 134°C for 5 minutes.
Presterilizing clearing
In order to remove any inorganic and organic contaminants (including protein, fat, mechanical and others), including drug residues from medical device and to decrease in general microbial contamination to facilitate subsequent sterilization presterilizing clearing is carried out.
The devices can be cleaned in two ways:
a) mechanical cleaning;
b) ultrasonic cleaning.
A. Mechanical cleaning
1) Soak devices with full immersion in the cleaning agent with filling the cavities and channels with cleaning agent right after the use;
2) Wash devices in the same cleaning agent in which it was soaked using a brush;
3) Rinse with running water (channels - using a syringe or electric suction);
4) Rinse with distilled water (channels - using a syringe or electric suction);
It is up to end user to ensure that cleaning agent is suitable for medical devices mechanical cleaning and use it in accordance with its instruction on use.
B. Ultrasonic cleaning
1) Fill the ultrasonic bath container with the devices (collapsible products were placed in disassembled form; products with locks - open), then the cleaning agent was added to at least 1/3 and not more than 2/3 of the volume of the container of the ultrasonic bath;
2) Process in an ultrasonic bath with the temperature of the cleaning agent at least 18°C;
3) Rinse with running water (channels - using a syringe or electric suction);
4) Rinse with distilled water (channels - using a syringe or electric suction);
It is up to end user to ensure that cleaning agent is suitable for use in ultrasonic baths and use it in accordance with its instruction on use.
Sterilization process:
Procedure:
1) Disinfect your hands;
2) Put on disposable gloves;
3) Put the cleaned the devices in the autoclave bag;
4) Carry out the sterilization in accordance with the instruction of the autoclave manufacturer at 134oC for 5 minutes.
Warning:
1) Do not use cleaning agents, detergents or disinfectants containing high percentage of chlorine and cleaners containing oxalic acid, strong alkalines (pH>9), strong acids (pH<4), phenols or iodophors, hydrogen peroxide, interhalogenic agents, halogenic hydrocarbons, strong oxidizing agents, organic solvents, aldehydes.
2) Do not keep mandrels in liquid medium for more than 3 hours.
3) Dry the mandrels thoroughly before sterilization.
4) Follow instructions of autoclave (sterilizer) manufacturer.
5) To avoid corrosion of the metal due to electrolysis, do not place devices in autoclave together with products made of aluminum, brass and copper.
6) Do not use / sterilize the mandrels in case of presence of traces of rust on the surface or traces of surface damage.
Polishing discs ##1.021, 1.069, 1.07* series, 1.73* series, 2.07* series, 2.73* series, 9.73* series, 10.73* series
Stem polishing discs ##1.020, 1.6** series, 1.76* series, 9.6** series, 9.76* series, 11.6** series
In case of risk of disc contamination discs can be sterilized using conventional steam autoclave at 121°C for 20 minutes.
Operating instructions
Preparation
1. Open the packaging.
2. Make sure that there are no:
- signs of violation of the integrity of the device (including cracks and chips),
- traces of rust or dirt on the surface.
Operating procedure
1. Remove excess composite and contour the restoration using a fine diamond or carbide bur.
2. Accurately open the package with discs to avoid squabbling and mixing of the discs and choose disc for gross reduction of necessary diameter.
3. Place disc for gross reduction by gentle pushing of the connector onto preliminary sterilized mandrel until the disc is secure connected (disc must not wobble on mandrel).
4. Start polishing at a speed not more than 10000 rpm. (speed and duration when using disc of another type see the Table)
5. When the polishing is finished wash away the residuals of polishing.
6. Remove the gross reduction disc from mandrel by positioning a thumbnail under the disc connector and pushing the disc away from the mandrel.
7. Place disc for contouring by gentle pushing of the connector onto mandrel until the disc is secure (disc must not wobble on mandrel) and repeat procedures 3 – 4 taking into account changed abrasiveness of the disc (see the Table).
When polishing pay attention to:
a. move in one direction: from gingiva towards restoration (back and forth movement over the composite-enamel margin is not recommended);
b. use light pressure;
c. keep the restoration surface and disc dry when polishing to reach more smooth and uniform effect;
d. cool the polished tooth with air to avoid dentin overheating.
Storage
Store discs and mandrels in a dry place.
Store discs away from direct sunlight. The storage at direct light can cause disc color change and flexibility decrease.
Discs and mandrels in plastic packages should be stored away from heating devices to avoid packaging damage.
Product shelf-life
Shelf-life of discs is 5 years since date of production.
Shelf-life of mandrels is unlimited.
Disposal
Used discs and unusable mandrels are to be disposed as class 3a "other non-hazardous wastes" according to WHO-UNEP/SBC 2005 coding
recommendations.
Warranty
Warranty time for mandrels is 1 year after the first use (guaranteed number of allowable reuses is 200).
Discs are single-use devices.
TOR VM will replace the product that is proved to be nonconforming.
It is up to user to ensure that the product is suitable for the intended process and purpose.
Any serious incident or non-compliance that has occurred in relation to TOR VM discs and/or mandrels should be reported by e-mail torvm77@gmail.com and/or tor.vm.de@googlemail.com.
In case of emergency (any serious incident that has occurred in relation to the device) please, contact
TOR VM
Tel.: (495) 225 54 17
e-mail: torvm@gmail.com
European representative
Gregor Kostunov
Tel/fax (49) 6221718120
E-mail: tor.vm.de@googlemail.com
Language
IFU is available in English and can be provided in any official Union language on customer request.
If you need IFU paper version, please contact
TOR VM
Tel.: (495) 225 54 17
e-mail: torvm@gmail.com
European representative
Gregor Kostunov
Tel/fax (49) 6221718120
E-mail: tor.vm.de@googlemail.com
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