Contraindications; Limitation Of Liability - Dentsply Sirona In-Ovation X Mode D'emploi

In-Ovation® X
Orthodontic Self-Ligating Brackets
INTENDED USE:
Indended to be used in orthodontic treatment of natural teeth.
INDICATIONS FOR USE:
Indicated for patients requiring orthodontic treatment by movement
of natural teeth

CONTRAINDICATIONS:

In-Ovation® X brackets should not be bonded to restorative or
compromised enamel surfaces.
Product is contraindicated for patients with an allergy to Nickel.
WARNINGS:
Single use only.
Device contains nickel and may cause allergic reactions.
PRECAUTIONS:
For professional use only. U.S. Federal law restricts this device to sale
by or on the order of a Dentist.
Bonding of brackets to compromised teeth (i.e., with large restorations,
to peg laterals, or pre-existing pathological conditions) can increase
the risk of tooth damage.
Do not use product for anything other than orthodontic purposes.
Instruct patients not to chew or bite hard substances such as hard
candy, ice or carrots.
Bonding to porcelain crowns or facings may cause chipping or
breakage of the crown or facing during treatment or debonding.
For positioning, hold the bracket in the mesiodistal direction. If the
bracket is held in the dental axis direction, the clip may close.
When bonding, take precautions with excess bonding material, or it
may adhere to the clip, adversely affecting the opening mechanism.
For a severe case of crowding, initially use thin round wire.
Do not reuse the product. Risks of reuse include infection and cross-
contamination to patient and healthcare provider.
If deformation or deterioration is recognized, do not use. Contact
manufacturer for assistance.
If an allergic reaction occurs, discontinue use immediately and direct
the patient to consult a physician.
ADVERSE REACTIONS:
Allergic reaction.
STEP-BY-STEP INSTRUCTIONS:
Color Code ID
Bonding Base
1. Bond the bracket to each tooth using an orthodontic adhesive.
Refer to orthodontic adhesive's Directions for Use.
2. At this time, the clip is in an "open" position. Avoid excess bonding
material coming in contact with the clip as it could become
solidified and interfere with proper clip functionality.
3. For positioning, align the mesiodistal wings of the bracket with
the long axis of the tooth, and the archwire slot with the occlusal
surface. Use the Vertical Scribe Line as a visual reference.
4. Insert the archwire into the slot, and push the clip lightly with a
fingertip. When fixing the wire to a largely rotated tooth, initially
use thin round wire (equivalent to Sentalloy® Blue) and seat the wire
with a Ligature Tucking Instrument.
5. When changing the wire, open the clip by inserting a pointed
instrument such as a scaler into the Keyhole on the facial portion of
the clip and pull clip in an occlusal direction.
SUGGESTED DE-BONDING PROCEDURE
For de-bonding, first fully scrape off the bonding material near the
base; place a ligature cutter or bracket de-bonding instrument in the
occlusal/gingival position and squeeze.
WARRANTY AND LIMITED REMEDY
Manufacturer warrants that this product is free from defects in
materials and manufacture.
Manufacturer's sole obligation and customer's sole remedy in the event
of a claimed defect shall be limited to replacement merchandise or
refund of the purchase price.
All implied warranties, including implied warranties of merchantability
or fitness for any particular purpose or use are disclaimed.

LIMITATION OF LIABILITY

Except where prohibited by law, Manufacturer will not be liable
for any loss or damages arising from this product, whether direct,
indirect, special, incidental, or consequential, regardless of the theory
asserted, including warranty, contract, negligence or strict liability. This
limitation does not apply to third party personal injury claims.
Clip
Keyhole
Vertical Scribe Line
Tie Wing
Archwire Slot
Clip
ENG