Product description
• Double sided diamond-coated oscillating metal strip
• Strip height: 3.6 mm
• Length of the diamond-coated part: 13 mm
• Sterilizable and reusable
Use in combination with:
• DentaSonic, W&H, KAVO, NSK, SIRONA or other oscillating HP
with or whiteout ligh, and with or whiteout water irrigation.
• Manual use with handle
Indications for Use
• DiaStrip is indicated for the removal of set cement, to break
contacts, for Interproximal Reduction (IPR) procedures, and for
polishing and finishing.
• DiaStrip (single-sided, double-sided and resin) is indicated for
both anterior and posterior teeth.
• Pass the strip back and forth gently and buccolingually only.
Contraindications
DiaStrip is contraindicated if the Instructions for Use (IFU) is not
strictly followed or with patients with poor enamel structure
(hypoplasia), high caries index, poor oral hygiene or severe tooth
crowding.
Warnings
! Avoid bending and levering: use of excessive force (strong leve-
ring) could lead to the breakage of the instrument.
! Avoid jamming or levering actions when oscillating, as this in-
creases the risk of instrument breakage.
! Avoid temperatures above 180°C which may affect the durabi-
lity of the instrument.
! Avoid applying forces greater than 3N as this could cause da-
mage to the instrument.
! To prevent patient from ingesting or inhaling the DiaStrip, prior
to using DiaStrip, thread a piece of dental floss through the arc of
the DiaStrip. Secure by tying a slipknot. Wrap the floss around one
of your other fingers to secure the DiaStrip.
! The consumption of the instrument lifetime until its worn out,
replacement and disposal is an exclusive decision of the physician
according to his operative needs.
! To ensure traceability during the instrument lifetime we recom-
mend to preserve the packaging.
Principles of safety
! Contact pressure: bend the strip 1-1.5 mm to achieve the ideal
1-2.5N operating force.
! Do not stop the motion of the file while the same is in the inter-
dental space
! In case of overcrowding open the interdental space using a we-
dge in the cervical area
! Do not bend, warp or leverage the instrument
! Not observing these precautions leads to a high risk in terms
of safety and can lead to the possible breakage or damage of the
instrument
Precautions
• Sterilize DiaStrip prior to patient use. See details below.
• Read the Instructions for Use (IFU) completely before using. Use
of DiaStrip inconsistent with IFU is at the sole discretion and sole
responsibility of the user.
• Do not use any DiaStrip that is damaged, bent, broken, or show
signs of wear.
• For maintaining anatomical contour in the posterior and to refine
the natural anatomy of the anterior, finish with the curved version.
• Use a gap gauge frequently during the procedure when gap wi-
dth accuracy is critical.
Adverse Reactions
• None known. However, DiaStrip is made from stainless steel
and contains nickel. Nickel may cause allergic reactions in some
patients.
No Reactions for allergic patients
• Resin Diamond DiaStrip is made from resin and NOT contains
nickel. Resin will NOT cause allergic reactions to patients.
Instructions for Cleaning, Sterilization and Disposal
Warnings: DO NOT use cold sterile or dry heat sterilization pro-
cesses.
Instructions and recommentation of use
DiaStrip Stripping with confidence
Limitations on reprocessing: DiaStrip can be sterilized up to 10
times. Resin DiaStrip can be sterilized up to 3-5 times.
INSTRUCTIONS
Point of use: Sterilize before first use and between patients.
Preparation for decontamination: It is best to wipe immedia-
tely after use to avoid contaminants drying, thereby making the
cleaning process more time-consuming and difficult. Immerse or
soak DiaStrip in a hospital grade enzymatic detergent such as en-
zymatic solution for 15 minutes.
Cleaning: Manual Clean thoroughly - Scrub all external surfaces
with a soft bristle brush until all visible soil has been removed. Use
a small diameter brush cleaner to clean cannulation holes. Inspect
for visible soil on exposed surfaces. Ultrasonically clean using a
solution that is recommended for dental instruments such as an
enzymatic solution for 5 – 10 minutes. Rinse DiaStrip under co-
pious amount of warm water for 2 -3 minutes and visually inspect
to confirm removal of debris.
Do not use highly aggressive chemical products (e.g. hydrochloric
acid, hydrogen peroxide), as they could corrode the instruments.
These substances can also impair the technical properties
of the plastics, i.e. change their hardness and durability.
Cleaning: Automated Not recommended
Disinfection: Not recommended
Drying: Allow to air dry in clean area. Blow lumens with clean air
using filtered air source or syringe.
Maintenance, inspection and testing: Visually inspect for
fractured or worn abrasive strip that could prevent proper function.
Discard in Sharps container.
Packaging: Bag in an FDA cleared sterilization pouch, Steriliza-
tion pouches are recommended.
Sterilization: EU and US Autoclave Parameters
Steam autoclave- Gravity (Wrapped)
Minimum Exposure Temperature: 121°C (250°F)
Minimum Exposure Time: 30 minutes
Minimum Dry: 30 minutes
EU Autoclave Parameters
Steam autoclave- Gravity (Unwrapped)
Minimum Exposure Temperature: 134°C
Minimum Exposure Time: 3 minutes
Minimum Dry: None
US Autoclave Parameters
Steam autoclave- Pre-Vacuum (Wrapped)
Minimum Exposure Temperature: 135°C (275°F)
Minimum Exposure Time: 3 minutes
Minimum Dry: 30 minutes
Storage: DiaStrip should be stored in the sterilization pouch until
ready for use with a maximum storage period of 6 months before
product needs to be re-sterilized. Unwrapped DiaStrip should be
used immediately after sterilization.
Recommendations for use
• Apply DentaSonic DiaStrips in interproximal areas according to
the IPR enamel reduction protocol for orthodontic treatments.
• A pre-opening of tight contact points using Denta-
Sonic DiaStrips Saw is suggested, Ref. DSS-1
• In case of very tight contact points separate the teeth by placing
a wedge cervically. This makes treatment more comfortable both
for operator and patient.
• Activate water spray during the entire treatment (minimum 50
mL/min).
• Regulate water flow in case of water excess or shortage.
• Insert the strip in a cervical direction while the contra-angle is
moving. This prevents the instruments from jamming.
• Once the tool is inserted into the hand-piece head
be sure it is fully and firmly fixed
• Switch on the hand-piece by turning on the micro-motor
• Set and bring the instrument to the recommended
speed before aplying it on the tooth
• With the file in motion enter the inter-proximal space to be trea-
ted with a cervical motion
• Proceed with the treatment paying attention to the speed and
the pressure applied
Risk Warnings
• Avoid bending and levering: use of excessive force (strong leve-
ring effect with the contra-angle) could lead to the breakage of
the instrument.
• Avoid jamming or levering actions when oscillating, as this incre-
ases the risk of instrument breakage.
• Do not exceed the 10'000 oscillations per minute to avoid brea-
kage of the instrument.
• Avoid temperatures above 180°C which may affect the durability
of the instrument.
• Avoid applying forces greater than 3N as this could cause da-
mage to the instrument.
• The consumption of the instrument lifetime until its worn out,
replacement and disposal is an exclusive decision of the physician
according to his operative needs.
• To ensure traceability during the instrument lifetime we recom-
mend to preserve the packaging.
Instructions for Use
Cement Removal and Break Contacts
Use DiaStrip Saw (Blue) serrated strips to remove set cement and
break contacts. • Insert the serrated blade between the teeth and
with a gentle "sawing motion", to remove the cement or to break
contacts.
Finishing and Polishing
Use DiaStrip Single-Sided Abrasive Strips for both anterior and po-
sterior teeth. When following the contour of teeth is critical, use
the Resin Abrasive Strips as they are better suited to this purpose.
• Select the desired grit metal strip (White – SuperFine, Yellow –
Fine). • Select the desired grit Resin Strips (Blue – UltraFine, Yellow
– Superfine, Green – Fine, White – Medium or Gray – Coarse).
• Hold the DiaStrip or the Resin DiaStrip between your thumb and
index finger. • In an angled position, begin a gentle "sawing mo-
tion" until light resistance is felt. • If needed, continue to other
grits until the proper finish/polish is achieved.
Interproximal Reduction (IPR)
Use Single-sided and Double-Sided DiaStrip in the sequence shown
below for IPR procedures. When following the contour of teeth is
critical, use the Resin DiaStrip Strips as they are better suited to
this purpose. For creating IPR spaces from 0.08mm to 0.2mm, use
the Single-Sided DiaStrip Abrasives; for IPR spaces greater than
0.2mm, use the Double-Sided DiaStrip Abrasives. • Regardless of
the strip type chosen (single, double-sided, straight metal or Resin)
as described above, begin with the superfine grit (White). • Hold
between the thumb and index finger. In an angled position, begin
a gentle "sawing motion" until very light resistance is felt. • It is
best to check the gap with a verified gap measuring gauge before
moving to the next color (grit) in the sequence. Once the desired
gap is achieved there is no need to continue to the next larger grit
size. • If additional space is needed, switch to the fine grit (Yellow)
and use in the same manner as described above. Check gap width.
• If additional space is needed, switch to medium grit (Red). Check
gap width. • If additional space is needed, switch to the coarse grit
(Blue). Check gap width. Continue until the desired gap is achie-
ved. • If needed, continue to lesser grits until the proper finish/
polish is achieved.
IPR Sequence Guide For Orthodontic Procedures
In order to create precise interproximal spaces for Orthodontic pro-
cedures, use DiaStrip color coded strips according to the sequence
outlined below. The reduction process (IPR) should begin with the
white single-sided grit (0.08 mm), and continue in sequence until
the desired space is achieved. Check the reduction with an appro-
ved gap measurement gauge before moving to the next color (grit)
in the sequence. If needed, continue to lesser grits until the proper
finish/polish is achieved.
Note: Use all versions of DiaStrip (single-sided – ESM1, double-si-
ded – ESM, and Resin – ES) in any area of the mouth. For maintai-
ning anatomical contour in the posterior and to refine the natural
anatomy of the anterior, finish by using the Resin Diamond coated
DiaStrip version.
DentaSonic Sagl
Tel. +41 41 510 20 20
Fax +41 41 510 20 21
Via Piodella 12
info@dentasonic.ch
6933 Muzzano