Dentsply Sirona Paloden 360 Gebrauchsinformation

Palodent® 360
Circumferential Matrix System
DIRECTIONS FOR USE – ENGLISH
Caution: For dental use only.
USA: Rx only.
1. PRODUCT DESCRIPTION
The Palodent® 360 Circumferential Matrix System is designed to be used as a matrix to
contain direct-placement restorative materials in posterior cavities involving proximal
surfaces. The Palodent® 360 matrix band with integrated tightener/retainer allows matrix
placement and retention without the need for bulky retainers or accessory placement
and tightener instruments, allowing for ease of placement, better access, clear view of
the operating field and greater patient comfort. Access for wedge placement (where
indicated) is not hindered by an external retainer. The single-use, disposable Palodent®
360 matrix bands allow proper subgingival and proximal contact adaptation while
protecting against cross-contamination.
1.1 INDICATION
The Palodent® 360 Circumferential Matrix System is indicated where placement of a
matrix band around a prepared tooth will facilitate contouring of a direct placement
restorative material (e.g., Class II preparations).
1.2 CONTRAINDICATIONS
None Known.
1.3 DELIVERY FORMS
The Palodent® 360 matrices are available in one thin gauge (thickness) in 3 heights:
4.5mm, 5.5mm, 6.5mm to fit a wide range of tooth sizes and shapes.
1.4 COMPOSITION
• Matrix Bands: Polished stainless steel
• Integrated tightener/retainer: Polyacetyl Thermoplastic
2. GENERAL SAFETY NOTES
Be aware of the following general safety notes and the special safety notes in other
chapters of these directions for use.
Safety alert symbol
This is the safety alert symbol. It is used to alert you to potential personal
injury hazards. Obey all safety messages that follow this symbol to avoid
possible injury.
2.1 WARNINGS
1. The Palodent® 360 system consists of small, sharp parts. As with all intraoral
instruments, care must be exercised to ensure stable handling and placement.
Placement of rubber dam or other suitable isolation is advised prior to operative
procedures. Wear suitable protective eyewear and gloves.
Aspiration: If aspiration of band or any part occurs seek immediate medical attention.
Ingestion: If accidental swallowing occurs, encourage patient to seek medical
assistance to locate swallowed part. If nausea or illness develop, seek
medical attention immediately.
Laceration: Palodent® 360 matrix bands are sharp, and may cut unprotected skin.
Handling bands with gloved hands is recommended. In the event a clean
band causes a skin laceration, employ usual first aid measures. Discard
and properly dispose of band.
2. Used matrix bands are contaminated. Follow proper exposure control plans. In the
event of an accidental exposure, follow recommended post-exposure procedures.
Following use of Palodent® 360 matrix bands, proper handling and disposal
techniques are required. Used matrix bands are contaminated and sharp. When
handling or disposing, use precautions as when handling or disposing other
contaminated sharps.
2.2 PRECAUTIONS
1. This product is intended to be used only as specifically outlined in the Directions For
Use. Any use of this product inconsistent with the Directions For Use is at the
discretion and sole responsibility of the practitioner.
2. Devices marked "single use" on the labeling are intended for single use only. Discard
after use. Do not reuse in other patients in order to prevent cross-contamination.
3. Avoid placing excessive pressure in an apical direction when placing or on placed
bands. Apical force may result in injury to periodontal tissues. (See Warnings)
4. Do not use accessory tightening tools with Palodent® 360 matrix bands. Injury may
result. (See Step-by-Step Instructions)
2.3 ADVERSE REACTIONS
1. Product misuse may cause failure resulting in respiratory, digestive, eye, skin, or
mucosa injury. (See Contraindications, Warnings and Precautions)
2. Failure to properly employ accepted handling and disposal techniques may present
biohazard. (See Warnings and Precautions)
2.4. STORAGE
Store Palodent® 360 matrix bands at room temperature, away from moisture or
excessive humidity.
3. STEP-BY-STEP INSTRUCTIONS
3.1. PRE-OPERATIVE STERILIZATION
Matrices are intended for single use, and are not supplied sterile. If desired, these
components may be sterilized one time by Pre-vacuum steam autoclaving, 132°C, 4
minutes, prior to clinical use. Paper/plastic steam sterilization pouches may be used, but
are not required. Follow pre-vacuum steam autoclave manufacturer's Instructions for
Use for loading and operation cycle.
3.2. CAVITY PREPARATION
Complete cavity preparation as usual utilizing rubber dam or other suitable isolation
technique. Technique Tip: Pre-wedging to achieve slight separation may facilitate matrix
placement and acceptable restoration proximal contact.
3.3. MATRIX SELECTION/PREPARATION-ENLARGING MATRIX CIRCUMFERENCE
There are three heights and one gauge of matrix band. To properly fit the tooth, matrix
should be slightly larger than the occlusal circumference. Using protected hands, grasp
the retainer body of a clean, new Palodent® 360 matrix band. Twist the thumb wheel
counterclockwise to unroll the coil slightly and enlarge the loop, or clockwise to take up
the coil and reduce the loop, if necessary.
3.4 POSITIONING MATRIX
Carefully slide matrix around tooth, through the interproximals using a downward
oscillating motion. Matrix may be positioned with the thumbwheel tightener at the
center of buccal or lingual or most secure remaining tooth wall, or in either interproximal
embrasure.
Technique Tips:
1. To seat matrix in tight interproximal spaces – Pre-wedging or use of a Palodent® Plus
or Palodent® V3 retaining ring (see Complete Directions for Use) or an Elliot
Separator on posteriors may gain temporarily required space.
2. To clear debris and facilitate seating – Use waxed floss or a soft wedge between tight
interproximals.
3. For hard to reach molars - Use locking college pliers to grip matrix along the side and
facilitate matrix seating. Release pliers when matrix is securely seated on tooth.
3.5 TIGHTENING THE MATRIX
3.5.1 Stabilize the matrix with gentle finger pressure apically until the matrix is fully
tightened. Check to be sure gingival tissue is not trapped between band and
tooth surface. If so, slightly lift and reposition band prior to tightening.
3.5.2 Grasp tightening thumbwheel with thumb and forefinger. Rotate barrel
clockwise. NOTE: The Palodent® 360 matrix system is designed for finger
tightening ONLY. When band is snug, and resistance is felt, STOP tightening.
The band is properly subgingivally tightened. Note: The integrated tightener/
retainer keeps matrix locked tightly until removal is desired.
Technique Tip: Where space or grip is limited, the Palodent® 360 matrix bands may be
tightened by grasping the thumbwheel and moving the retainer body forward in a
ratchet motion, releasing the thumbwheel and allowing the body to return back to
center, re-grasping thumbwheel and repeating until band is tight. Reverse the direction
of the retainer body movement to loosen.
Technique Tip: Palodent® 360 matrix bands are compatible with Palodent® Plus or
Palodent® V3 retaining rings to further stabilize and assist with proper embrasure form.
When restoring an MOD preparation, two rings may be placed facing opposite directions
(See Complete Directions for Use).
3.6 PLACEMENT OF RESTORATIVE
3.6.1 Place wedges as desired (buccal and/or lingual).
3.6.2 Burnish contact areas.
3.6.3 Place desired restorative material as per restorative material manufacturer's
directions for use.
3.7 REMOVING THE MATRIX
3.7.1 Following appropriate restorative curing/setting, remove retaining rings and
wedges, open and remove the matrix by reversing (counterclockwise) rotation
on the retainer thumbwheel until matrix is loose. This spool will usually remain
attached to the band upon removal, but may become dislodged. If spool has
separated from band, remove it from the mouth and properly discard.
3.7.2 Support the restoration marginal ridge(s) with a condenser. Slide loosened
matrix buccally or lingually, while removing matrix occlusally. Properly discard
matrix. Technique Tip: It is advisable to "post-cure" light cured restorative
materials following matrix removal from all surfaces, including proximo-facial
and lingual line angles.
Small parts-ingestion/inhalation
• Ensure matrix is grasped securely with fingers or locking college pliers
during withdrawal from the mouth.
• Recover all pieces from the mouth immediately.
4. HYGIENE
Cross-contamination
Do not reuse single use products.
Dispose of in accordance with local regulations.
Sterilization of matrices pre-use (if desired) may be accomplished (one time) as outlined
below:
Limitations Cold liquid immersion disinfection/sterilization, automated washer/disinfection
on have not been tested or validated for efficacy and are not recommended for use.
processing
Packaging Paper/plastic steam sterilization pouches may be used but are not required
Sterilization Steam autoclaving:
Prevacuum: Full cycle 132°C, 4 minutes
Follow manufacturer's instructions for loading and operation cycle
Drying Use the drying cycle of the autoclave, minimum 30 minutes.
Storage Instruments steam autoclaved bagged should remain bagged until ready for use.
Prior to use, inspect the sterilization pouch and the matrix. If the integrity of the
pouch has been compromised, the matrix should be disposed of in accordance
with local regulations.
Instruments steam autoclaved unwrapped should be used immediately.
5. LOT NUMBER AND CORRESPONDENCE
1. The following should be quoted in all correspondences:
• Reorder number
• Lot number on the package
• Copy of proof of purchase
2. Any serious incident in relation to the product should be reported to the
manufacturer and the competent authority according to local regulations.
Manufactured for
Dentsply LLC
38 West Clarke Avenue
Milford, DE 19963 USA
Tel.: 1-302-422-4511
www.dentsplysirona.com
©2020 Dentsply Sirona. All Rights Reserved. 559600 WEB (R 11/20/20)
115-DV0
Dentsply De Trey GmbH Distributed by
De-Trey-Str. 1 Dentsply Canada
78467 Konstanz 525 Rowntree Dairy Rd
Germany Woodbridge, Ontario
Tel.: 49-7531-583-0 L4L 7K6 Canada
www.dentsplysirona.com