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 Page 1 of 6

N.D. SURGICAL INDUSTRIES

Device Description and Specification

Dental Instruments

Dental instruments are designed to perform either diagnostic or oral use to locate the cause of a problem, or to treat
a problem once it has been found. Each of the thousands of Dental instruments is designed to perform a specific
function. Instruments manufactured by N.D. SURGICAL INDUSTRIES are categorized as following:

 Clinical and Dental Instruments Sets

 Dental Implants Instruments
 Diagnostic, Periodontal & Restorative Instruments
 Extracting Forceps
 Maxillofacial Surgery Instruments
 Root Elevator
 Orthodontic Instruments
 Surgical Instruments

Product Specification
Design Standard: As per Catalogues / Supplied by the Customer
Surface Finish: Mirror or Satin / Dull finish
Etching (Device marking): As per customer’s requirement
Device Drawing: Stainless steel made Dental Instruments listed in
catalog having complete description in the form of
drawings with respect to their components. These
drawings contain comprehensive information
including device name, size, material, code no.
and also show dimensional and tolerance control.

Product Classification:
As per directive 93/42/EEC and updated directive 2007/47/EEC rule 5 the reusable surgical and dental
instrument is in class-I

Risk
To avoid infection, the instruments should be rinsed and dry after the use. It should be autoclave or
sterilize for re-use.
 Page 2 of 6

N.D. SURGICAL INDUSTRIES

Device Description and Specification

Specification of Raw Materials: (Materials Component)

Stainless Steel Rod 16mm of 410 Grade used in the production containing the following
contents.
Chromium (Cr) : 12.357 12.357%
Carbon (C) : 0.200 0.200%
Phosporus (P) : 0.021 0.021%
Silicon (Si) : 0.268 0.268%
Manganese (Mn) : 0.537 0.537%
Sulfur (S) : 0.016 0.016%
Nickel (Ni) : 0.105 0.105%
Iron : 86.496 86.496%
Total 100%

INTENDED USE
Dental Instruments are intended for use in the Dental Clinic to diagnostic or oral use to locate the cause of a
problem, or to treat a problem once it has been found.

INDICATION
It must be used appropriately and carefully.

CONTRAINDICATIONS
The improper use of a Dental instrument during handling, surgical use or reprocessing, for which they are
indicated, may result in damaged or broken instruments.

PRECAUTIONS
 When reprocessing Dental instruments, always handle with care, wearing protective clothing,
gloves and eyewear in accordance with local Health & Safety procedures.
 Dental instruments are manufactured from different metals should be processed separately to avoid
electrolytic action between the metals resulting in pitting and rusting of stainless steel instruments.
 Delicate / Micro Dental instruments require special handling to prevent damage to the tips. Use
caution during cleaning and sterilization. A non-fibrous sponge should be used to wipe off all blood
and debris.
 Do not use excessive stress or strain at joints; misuse will result in misalignment or cracks at the
box locks or jaws.
 Gold Plating and titanium instruments that are color anodized may lose their color over time
through normal use and reprocessing.
 Keep ebonized instruments separate from other stainless steel instruments to avoid scratches to and
removal of the ebonized coating.
 Page 3 of 6

N.D. SURGICAL INDUSTRIES

Device Description and Specification

Maintenance. Handling, Storage and Disposition:

 The device is intended for single use only and must be sterilized before use. Any restrictions on
use are indicated in the label & instructions for use (IFU)
 No special decomposition or disposal required for these Instruments, as they don’t contain any
toxic or hazardous material; the material stainless steel is recyclable in ordinary steel manufacturing
units

Product Shelf Life

 Instruments are made of stainless steel, which if stored in appropriate conditions to protect from
 rust then shelf life is unlimited but for best quality performance shelf life is defined as 5 years.

PREPARATION FOR DECONTAMINATION

 Reprocess all instruments as soon as it is reasonably practical following use.
 Follow instructions and warnings as issued by manufacturers of any decontaminants, disinfectants
and cleaning agents used. Wherever possible avoid use of mineral acids and harsh, abrasive agents.
 Do not use high acid (pH 4.0 or lower) or high alkaline (pH 10 or higher) products for disinfection.
Neutral pH detergents 7.0 – 9.0 are preferred.
 If appropriate, disassemble prior to cleaning and sterilization, without the use of tools unless
specifically provided by the manufacturer. Additional instructions required for disassembly will be
made available with the product or the manufacturer.
 Open jaws of hinged instruments for cleaning. Give special attention to joints and serrations.
 Remove gross contaminants with a steady stream of lukewarm/cool water, not to exceed 35º C (95º
F). Rinse each instrument thoroughly. Do not use saline or chlorinated solutions.
 Do not soak instruments in hot water, alcohol, disinfectants or antiseptics to avoid coagulation of
mucus, blood or other body fluids. Do not exceed 2 hours soaking in any solution.
 Do not use steel wool, wire brushes, pipe cleaners or abrasive detergents.

Materials:
 Stainless steel material used for manufacturing are in conforming ASTM-F-899-12 / ISO 7153-1.
 Stainless Steel used is also biocompatible material for the medical devices.

Maintenance of Instruments
 New Instruments
Newly purchased instruments must be cleaned, lubricated and autoclaved immediately before use.
 Correct Use
Obvious as it sounds, it bears repeating: instruments are designed for a particular purpose and
should be used only for that purpose. Even the strongest instrument can be damaged when used
inappropriately, i.e., when a Ligature Wire Cutter is used to cut hard / heavy wire.
 Water and Stainless Steel
Ordinary tap water contains minerals that can cause discoloration and staining.
Therefore, we recommend the use of distilled water for cleaning, disinfecting, sterilizing and
rinsing instruments. To avoid staining, use a cleaning solution with a pH near neutral (7).
 Page 4 of 6

N.D. SURGICAL INDUSTRIES

Device Description and Specification

Instruments should be placed in distilled water immediately after use. They should never be placed
in saline solution, as it may cause corrosion and eventually irreversible pitting.

 Manual Cleaning and Soaking

When handling instruments, be very careful not to damage their fine tips and mechanisms. If
instruments have been exposed to blood, tissue, saline or other foreign matter, they must be rinsed
in warm (not hot) water before these substances are allowed to dry. Failure to do so may result in
rust. After rinsing, immerse them in a cleaning and disinfecting solution.
Because many compounds, including certain chemicals, are highly corrosive to stainless steel, rinse
and dry instruments immediately, in case they have come in contact with any potentially harmful
substances.
If no ultrasonic cleaner is available, clean the instrument very carefully. Pay particular attention
when cleaning box locks, serrations, hinges and other hard-to- reach areas. What's more, use nylon
(not steel) brushes, such as KM 39-684, and warm (not hot) cleaning solutions. Follow the
manufacturer's instructions for the preparation of the cleaning solutions. Remember to change these
solutions daily or can be sterilized.
 Instrument Checkup
The best time to review the condition of instruments is after they have been cleaned and lubricated
and have cooled off. Consider the following:
 Function:
“Sharps” must cut cleanly (re-sharpen if needed) and close properly. Check for burrs along the
cutting edges. Needle holders and clamps must engage properly and meet correctly at the tips.
 Surface:
Carefully inspect surfaces for any sign of staining, cracking or other irregularities.
Common sources of staining are:
o Inadequate cleaning
o Mixing dissimilar metals
o Impurities in the water
o Unsuitable or improper preparation and usage of cleaning and disinfecting or maintenance
agents
o Noncompliance with operating procedures of cleaning and sterilizing equipment

Instructions for Use

Devices: Dental Instruments (Non Sterile, Stainless steel) supplied by company

comprising fixed assemblies and simple hinged assemblies made of
stainless steel
Warnings Never:

 Misuse instruments or overstrain joints or racks.

 Use abrasives on instruments, as this will spoil the surface
finish. This may later cause discoloration, rusting or pitting.
 Handle instruments by their tips. These should be cleaned by
trained personnel only who will ensure the delicate working
ends are adequately protected during storage or sterilization.
 Page 5 of 6

N.D. SURGICAL INDUSTRIES

Device Description and Specification

 Pack instruments with other, heavier instruments. Remember

always - heavy instruments on the bottom and light instruments
on the top.
 Use general-purpose oils for instruments; only water-soluble
lubricants should be used.
 Leave instruments soaking longer than necessary in chemical
sterilizing solutions. After they have been sterilized they
should be washed thoroughly in warm water to remove all
traces of the chemicals to prevent discoloration or pitting.
 Store damp instruments. They must be thoroughly dried first.

Instructions Always:

 Check all instructions for use and sterilization of new

instruments. Unless otherwise directed they should be
inspected, cleaned, rinsed and lubricated before being put into
service.
 Lubricate after cleaning with a proprietary water-soluble
instrument lubricant.
 Follow approved cleaning procedure of hospital.
 Do not use corrosive cleaning agents. We recommend cleaning
solutions and rinses with ph 7.0.
 Do not use abrasive cleaners & brushes with hard bristles.
 Use distilled water for rinsing only. Water with chloride
contents may damage or even destroy the instruments.
 Do not leave instruments in cleaning or disinfecting solutions
for long terms (over night or weekend), the instruments can be
destroyed.
 Ensure all instruments are only used for the purpose for which
they were designed.
 Handle all instruments gently. Never overstrain, drop or
misuse them.
 Check all instruments for damage after use.
 Give special attention to micro instruments. Their fine tips can
easily be damaged by contact with other instruments or the
sides of the case in which they should be kept. Hand cleaning
is preferable.
 Ensure all instruments are thoroughly dried before being
stored.
 Pack instruments carefully with the heavier ones lying on a
piece of cloth or towel at the bottom.
 Store and sterilize bow-handled instruments on a special
holder. Always leave racks and ratchets open.
 Check the hardness of the water used in the autoclave. Too
hard water will leave a deposit on the instruments.
 Page 6 of 6

N.D. SURGICAL INDUSTRIES

Device Description and Specification

 If a water softener is used ensure it is at the manufacturers

recommended level. Too much may cause discoloration or
pitting.

Sterilization Instruments should be sterilized by moist heat sterilization method with

270 F (132C) for 15 minutes (Validated in accordance with EN ISO
17665-1-2006 prior to use in surgery. It is recommended that
sterilization temperatures should not exceed 280F (137C).

Storage Non-sterile instruments or sterile wrapped instruments should be stored

in dry, clean conditions at an ambient room temperature.
Disposal No special decomposition or disposal required for Surgical Instruments
as they don’t contain any toxic or hazardous material; the material
stainless steel is recyclable in ordinary steel manufacturing units.

N.D. SURGICAL INDUSTRIES

SIALKOT - PAKISTAN
Manufacturer
Mede in Pakistan Zaheer Ahmad
Partner