Intended for orthodontic movement of natural teeth by a qualified medical professional.

The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-specific orthodontic appliances.

The LightForce Orthodontic System consists of patient-specific brackets made out of metal or ceramic (LightBrackets), patient-specific bracket placement trays (LightTrays), and instructions for use. The use of LightTrays is optional, and instructional steps are below. If choosing to direct bond brackets, follow standard orthodontic office procedures.

A .STL file must be submitted to plan.lightforceortho.com or uploaded directly from the scanner to initiate treatment.

LightForce Orthodontics does not provide commercially available arch wires, ligatures, adhesives, or other bonding agents. All use of such products should be used according to the manufacturer's instructions.

Dental brackets 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 regards to malocclusion. The system should be used by licensed orthodontists and it is indicated for use with patients of all ages according to a prescription.

LightForce Orthodontics (LFO) receives the patient's digital data via commercially available communications tools from the DDS/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 jigs are manufactured and shipped to the DDS/DMD.

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 Replacements 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-safe container.

STEP 5: Etch and prime the tooth using the orthodontist’s preferred method.

STEP 6: Place the rebond tray on the patient’s teeth with occlusal and facial pressure. Cure with UV light.

STEP 7: Remove the tray and perform a final cure from all angles.

Position the plier parallel to the bracket, fully seat prongs at the base, and rock plier mesial/distal while lightly squeezing until bracket debonds.

Guide a straight-edge plier along the gingival and occlusal base of the tube. For ceramic brackets, position along the ridge for closer access to the tooth and to reduce hook breakage. 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.

Case Scenarios not currently supported*:

*Final determination on case compatibility will be at the discretion of the LightForce Orthodontics Treatment Planning Technicians

Due to the hardness of ceramic brackets, bonding ceramic brackets in occlusion should be avoided to prevent wearing of enamel surfaces during all phases of treatment.

LightForce Orthodontic Brackets can withstand all normal torque requirements. However, care should be taken when making torquing activations. Large corrections with full size stainless steel wires may result in bracket failure and should be avoided.

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 (i.e. large restorations, peg laterals, or pre-existing pathological conditions) enamel surfaces may cause chipping or breakage of the crown or facing during treatment or debonding.

LightForce Orthodontic Brackets are for single patient use only.

Cases should not be stored above normal room-temperature.

Safety and compatibility in Magnetic Resonance (MR) Environment have not been evaluated. The bracket system 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.

LightForce Orthodontics Ceramic Brackets are identifiable by a tooth number identification on the mesial gingival tie wing and a dot on the distal gingival tie wing face.

(1) ISO 15223-1: 2021

Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied

a. Showing and hiding elements can be completed by clicking the associated buttons within the “View Controls” Dialog (Image 1) for:

i. Initial - the patient’s teeth as presented in the original digital impression

ii. Final - the planned finish location of the patient’s teeth

iii. Brackets

iv. Wire

v. Root Vis - If roots are available

vi. Gingiva

vii. Turbos

viii. Teeth View Tools: Upper, Right, Anterior, Posterior, Left, Lower

ix. Occlus - a heat map off the upper and lower model occlusion

x. TMT - tooth movement table

xi. Bond - a view of the teeth planning to be bonded

xii. Super - an opaque rendering of the initial tooth locations to allow seeing both initial and final at the same time.

xiii. Anim - Animation tool to show a start to finish video of the tooth movement and final bite jump

a. Mouse Clicks or keyboard selections allow for:

i. Single or multiple teeth selection

ii. Single or multiple bracket selection

iii. Rotation or translation of selected objects around existing axis including the objects’ intrinsic axis, the jaw axis, the patient’s axis (TMJ)

1. Visual widgets (mouse selection) and button / text based widgets allow for rotation and translation. (Image 2)

b. Mouse left click shall be used to select or unselect a tooth. Selected teeth shall have a highlight color to demonstrate they are selected. (Image 2)

c. A click-based dialog is provided to incrementally move teeth. (Image 3)

a. Workflow buttons allow saving and approving the treatment plan.

i. Approval for manufacturing - After reviewing the treatment plan, the approved treatment plan may be submitted for manufacturing.

ii. Save - The latest changes may be saved after making modifications to the treatment plan save

Manufactured by: © 2025 LightForce. Confidential and Proprietary. LightForce Orthodontics I 400 Research Drive Wilmington, MA 01887 I www.lightforceortho.com

Sponsor Information (Australia only): Freyr Australia Pty Ltd 46 Dora St, Blacktown, NSW 2148, Australia