Self-Ligating Bracket Debonding Instrument Instructions

AENGLISH Product Name 3M™ Unitek™ Self-Ligating Bracket Debonding Instrument, 804-170, 1/Ea Product Description The Unitek Self-Ligating Bracket Debonding Instrument is a specially modified pair of stainless steel pliers used to debond SmartClip Brackets and Clarity Advanced Ceramic Brackets. The instrument contains a nitinol insert which is held by a slotted screw. TM

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Intended Use This product is intended for use in orthodontic treatment. Indications for Use The Unitek Self-Ligating Bracket Debonding Instrument removes SmartClip Brackets and Clarity Advanced Ceramic Brackets from teeth upon completion of orthodontic treatment or as desired by an Intended User. The insert controls the removal of the bracket from the tooth upon debonding and helps to retain the bracket in the instrument once removed. May be used with or without the archwire engaged in the bracket slot. Contraindications None Intended Users Educated orthodontic professionals, i.e. orthodontist, orthodontic assistants/hygienists, who have theoretical and practical knowledge on usage of orthodontic products. Intended Patient Population include children, teens and adults as recommended by an Orthodontist. An Orthodontist is a dental specialist who is concerned with the study and treatment of malocclusions (imperfect positioning of the teeth when the jaws are closed), which may be a result of tooth irregularity, disproportionate jaw relationships or both. Clinical Benefit The Unitek Self-Ligating Bracket Debonding Instrument is confirmed to be safe and perform as intended. The clinical benefits include those of specifically designed orthodontic hand-held devices intended to perform various tasks during orthodontic treatment. These tasks include debonding self-ligating bracket. Precautions For Patients Safety glasses recommended for patient when using these instruments. For Dental Personnel Use instruments for indicated use only. Failure to do so may result in breakage of the instrument and injury to patient or orthodontic professional. Safety glasses recommended for orthodontic staff when using these instruments. Stainless steel contains nickel and/or chromium. A small percentage of the population is known to be allergic to these metals. If an allergic reaction occurs, direct patient to consult a physician.

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Instructions for Use Instrument Descriptor: A. Archwire Slot B. Nitinol Insert C. Bracket Gripping Shelf D. Screw holding Nitinol Insert in place Bracket Debonding 1. Remove adhesive flash around base of bracket to be debonded. Note: Failure to remove flash around bracket base, especially on the mesial-distal sides, may result in incomplete debonding. 2. Place the Nitinol Insert of the debonding instrument vertically into the center of the self-ligating bracket, perpendicular to the archwire slot. Be sure that the ledges of the instrument are symmetrically positioned against the labial surfaces of the bracket. (Figure 1) 3. Squeeze instrument handles until the bracket deforms. Gently rock the bracket in the mesial or distal direction to completely separate the bracket from the enamel. (Figure 2)

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Storage Conditions Not applicable Cleaning and Disinfection Refer to Reprocessing Instructions for Reusable Non-Sterile Devices, REF 011-650. SDS and Disposal Safety Data Sheets are not applicable to instruments. To be disposed in accordance with the local or regional regulations. Please pay special attention to the disposal of contaminated waste to avoid health risks because of improper handling. Customer Information Please report a serious incident occurring in relation to the device to 3M and the local competent authority (EU) or local regulatory authority. No person is authorized to provide any information which deviates from the information provided in this instruction sheet. Warranty 3M Unitek warrants that this instrument will be free from defects in materials and manufacture for a period of 1 year from the date of purchase. Failure to follow recommended use, maintenance and sterilization procedures will void all warranty claims. Recommended maintenance includes cutter tip/blade re-sharpening and reconditioning (cleaning, polishing, adjusting screw as necessary) every six months. 3M Unitek’s sole obligation and customer’s sole remedy in the event of a claimed defect shall be limited to, at 3M Unitek’s option, repair, replacement of the product, or refund of the purchase price.

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All instruments should be sent to the 3M Unitek Authorized Service Center at the address below for evaluation to determine credit, replacement, or repair. The Authorized Service Center will determine, upon receipt of instrument, if the instrument is to be covered by warranty. Materials and manufacturing are the only items covered by this warranty. Misuse or abuse will void warranty. Buyer will be contacted regarding repair charges for out of warranty instruments. 3M Unitek – Authorized Service Center Precision Plier Service 14175 Telephone Avenue, Suite D Chino, CA 91710-5762 Phone: 1-800-229-9060 USA, Canada Worldwide: Phone: 909-590-2085 Fax: 909-590-8604. Waiver of Implied Warranties 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, 3M Unitek will not be liable for any loss or damages arising from any product, whether direct, indirect, special, incidental or consequential, regardless of the theory asserted, including warranty, contract, negligence or strict liability. Symbol Title

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Symbol

Unique device identifier

Indicates bar code to scan product information into patient electronic health record.

Importer

Indicates the entity importing the medical device into the EU.

Rx Only

Indicates that U.S. Federal Law restricts this device to sale by or on the order of a dental professional. 21 Code of Federal Regulations (CFR) sec. 801.109(b)(1).

CE Mark

Indicates conformity to European Union Medical Device Regulation or Directive.

Green Dot

Indicates a financial contribution to national packaging recovery company per European Directive No. 94/62 and corresponding national law. Packaging Recovery Organization Europe.

Package unit

Indicate the number of units in the package. Source: ISO 7000-2794

Description and Reference

Manufacturer

Indicates the medical device manufacturer as defined in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC. Source: ISO 15223, 5.1.1

Authorized Representative in European Community

Indicates the authorized representative in the European Community. ISO 15223, 5.1.2

Date of Manufacture

Indicates the date when the medical device was manufactured. Source: ISO 15223, 5.1.3

Batch code

Indicates the manufacturer’s batch code so that the batch or lot can be identified. ISO 15223, 5.1.5

Catalogue number

Indicates the manufacturer’s catalogue number so that the medical device can be identified. ISO 15223, 5.1.6

Consult instructions for use or consult electronic instructions for use

Indicates the need for the user to consult the instructions for use. Source: ISO 15223, 5.4.3

Medical Device

Indicates the item is a medical device.

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