Intended Use
Intended for orthodontic movement of natural teeth by a qualified medical professional.
Indications For Use
LightBracket Metal is a device consisting of a set of custom 3D-printed stainless steel orthodontic appliances matched to a particular patient’s treatment needs as determined by a prescribing dentist or orthodontist. It is designed to be utilized in conjunction with the LightForce Orthodontic System Treatment Planning Software (TPS) and patient-specific bracket placement trays (LightTrays).
Instructions For Use
LightBracket Metal consists of patient-specific brackets and molar tubes 3D printed from stainless steel. The device is designed to be used in conjunction with the LightForce Orthodontic System, including LightTrays, and TPS. The use of LightTrays is optional, and instructional steps are below. If choosing to direct bond brackets, follow standard orthodontic office procedures.
An .stl file of the patient’s dental arches must be submitted to plan.lightforceortho.com or uploaded directly from the scanner to initiate treatment.
LightForce Orthodontics, Inc. does not provide commercially available arch wires, ligatures, adhesives, or other bonding agents. All use of such products should be according to the manufacturer's instructions.
Description and Principles of Operation
LightBracket Metal orthodontic appliances are devices that are designed to be bonded to teeth which allow the orthodontist to align and straighten teeth and help to position them with regard to malocclusion. The device should be used by licensed orthodontists and it is indicated for use with patients of all ages according to a prescription.
LightForce Orthodontics, Inc. (LFO) receives the patient's digital data via commercially available communications tools from the Doctor of Dental Surgery (DDS) or Doctor of Medicine in Dentistry (DMD). LFO prepares a final tooth setup and bracket placement plan and returns the digital data back to the DDS/DMD. The orthodontist can then view, measure, and modify the case using the TPS. Once approved, brackets and LightTrays are manufactured and shipped to the DDS/DMD.
Bonding Instructions
STEP 1 Add light-cured orthodontic adhesive* of choice to the base of the LightBracket Metal, and ensure brackets are positioned correctly in the IDB trays. Store in a light-shielded area. | |
STEP 2 Polish, dry, and isolate the patient’s teeth from saliva. | |
| STEP 3 Etch/prime the teeth using the orthodontist’s method of choice. |
STEP 4 Place LightTrays on patient’s teeth with mild occlusal and facial pressure, and cure with UV light. | |
| STEP 5 Remove LightTray, and cure brackets again from all angles for final cure. |
| STEP 6 Ligate initial wire to brackets using conventional elastomeric “O-rings” or steel ligatures. |
Bracket Rebonding Procedure
If a spontaneous bond failure occurs, follow these steps to rebond the bracket:
STEP 1: Clean excess adhesive from the affected tooth.
STEP 2: Polish, dry, and isolate the area to prevent moisture contamination.
STEP 3: Locate the replacement bracket in the Replacement Parts Box. Detach the individual LightTray segment, removing any bridging material.
STEP 4: Apply a thin layer of adhesive to the bracket pad and store it in a light-shielded area.
STEP 5: Etch and prime the tooth using the orthodontist’s preferred method.
STEP 6: Place the rebond tray on the patient’s specific tooth with occlusal and facial pressure. Cure with UV light.
STEP 7: Remove the tray and perform a final cure from all angles.
Bracket Debonding Procedure
BRACKETS Position a standard bracket removal plier along the gingival and occlusal sides at the base, and apply controlled gingival-occlusal torquing pressure until the bracket releases. | Brackets |
TUBES Guide a straight-edge plier along the gingival and occlusal base of the tube. Once the plier prongs are firmly positioned at the base, apply gentle torquing pressure in a gingival-out direction, away from the tooth, until the tube releases from the surface. | Tubes |
Precautions
Case Scenarios not currently supported*:
Missing canine cases where canines will be replaced by implants
Rotations or crowding so severe that an insufficient labial surface is available for bonding
Existing appliances such as molar tubes or bands are present
*Final determination on case compatibility will be at the discretion of the LFO Treatment Planning Technicians
Instruct not to chew or bite hard substances such as hard candy, ice, or carrots. Careful and thorough patient instruction is key to avoiding appliance or enamel damage.
Bonding to porcelain crowns or facings, restorative, or compromised enamel surfaces (i.e. large restorations, peg laterals,or pre-existing pathological conditions) may cause chipping or breakage of the crown or facing during treatment or debonding.
LightBracket Metal appliances are for single patient use only.
Warnings
LightBracket Metal contains nickel which can cause allergic reactions in some individuals. Patients with a known allergy to nickel should avoid use of the metal brackets and consult with their orthodontist for alternatives.
Safety and compatibility in Magnetic Resonance (MR) Environment have not been evaluated. LightBracket Metal has not been tested per ASTM F2503-20 for heating, magnetically induced displacement, torque or resultant image artifacts. Safety of the bracket system in an MR environment is not known. Placing a patient with this bracket system in an MR environment may result in patient injury and/or image artifacts.
LightBracket Metal Identification
LightBracket Metal appliances are identified either by a tooth number identification on the bracket slot and a dot on the distal gingival tie wing face for brackets and tooth number identification on the buccal face of molar tubes.
Symbol Glossary
Symbol | Title/Designation No. of Standard | Title of Symbols | Reference No. | Description |
| ISO 15223-11 | Manufacture | 5.1.1 | Indicates the medical device manufacturer, as defined in EU Directive 90/385/EEC, 93'42/EEC and 98/79/EEC. |
| ISO 15223-11 | Date of Manufacture | 5.1.3 | Indicates the date when the medical device was manufactured. |
| ISO 15223-11 | Serial Number | 5.1.7 | Indicates the manufacturer's serial number so that a specific medical device can be identified. |
| 21CFR801.109 (b)(1) | Prescription device labeling statement | N/A | CAUTION: Federal law (USA) restricts this device to sale by or on order of a physician. |
| ISO 15223-11 | Do not re-use | 5.4.2 | Indicates a medical device that is intended for one use, or for use on a single patient during a single procedure. |
| ISO 15223-11 | Non-sterile | 5.2.7 | Indicates a medical device that has not been subjected to a sterilization process. |
| ISO 15223-11 | Consult instructions for use | 5.4.3 | Indicates the need for the user to consult the instructions for use. |
(1) ISO 15223-1: 2021
Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied
Manufactured by: LightForce Orthodontics, Inc. I 400 Research Drive Wilmington, MA 01887 I www.lf.co
Sponsor Information (Australia only): Freyr Australia Pty Ltd 46 Dora St, Blacktown, NSW 2148, Australia
For any questions, contact our LightForce Customer Support team:
Chat Bot and Live Chat (Teal chat bubble icon located at bottom right of the Doctor Portal > Patients page)
SMS (US): +1 855 528 8045 / (CA): +1 506 498 8788
Phone (US): +1 866 506 3070 / (CA): +1 506 499 8850
Email: [email protected]