Who is the manufacturer of LightForce Orthodontic System (LFO System)?

Lightforce Orthodontics filed the 510(k) submission for LightForce Orthodontic System (LFO System) (K200148).

What is the FDA product code for LightForce Orthodontic System (LFO System)?

NJM. It is classified under 21 CFR 872.5470 as a Class 2 device in the Dental panel.

What is the regulatory pathway for LightForce Orthodontic System (LFO System)?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like LightForce Orthodontic System (LFO System)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

LightForce Orthodontic System (LFO System)

Q: What are the predicate devices for LightForce Orthodontic System (LFO System)?

LightForce Orthodontic System (K183542).

K200148 · Lightforce Orthodontics · NJM · Feb 21, 2020 · Dental

Device Facts

Record ID	K200148
Device Name	LightForce Orthodontic System (LFO System)
Applicant	Lightforce Orthodontics
Product Code	NJM · Dental
Decision Date	Feb 21, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5470
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

Intended Use

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

Device Story

System comprises treatment planning software (TPS), patient-specific ceramic brackets, and placement jigs. Input: patient digital impression (3D files). Process: orthodontist uses TPS to view, measure, and modify tooth setup/bracket placement; LFO manufactures patient-specific components via additive manufacturing. Output: custom brackets and placement jigs. Used in orthodontic clinics by orthodontists. Orthodontist bonds brackets to teeth using jigs and ligates wires. Benefits: patient-matched appliances for malocclusion correction. Software update (v3.1 to v4.0) improves architecture, hosting, and UI; adds movement accuracy around jaw/TMJ axes.

Clinical Evidence

No clinical performance testing conducted. Substantial equivalence supported by bench testing of software validation and comparison of device features/functions to predicates.

Technological Characteristics

System includes patient-specific ceramic brackets, placement jigs, and TPS. Additive manufacturing used for components. Connectivity: HTTPS transmission of impression data. Software: TPS v4.0 for case planning, viewing, and measurement. No patient-specific arch wires, ligatures, or adhesives included.

Indications for Use

Indicated for orthodontic patients requiring correction of malocclusions using patient-matched orthodontic appliances.

Regulatory Classification

Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

Predicate Devices

LightForce Orthodontic System (K183542)

Reference Devices

LightForce Orthodontic System (K181271)

Related Devices

K181271 — Signature Orthodontic System · Signature Orthodontics · Jun 13, 2018
K222764 — LightForce Orthodontic System · Lightforce Orthodontics · Sep 14, 2022
K183542 — Signature Orthodontic System · Signature Orthodontics · Jan 2, 2019
K232827 — LightForce Orthodontic System · Lightforce Orthodontics · Sep 14, 2023
K182338 — Blue Sky Bio Computerized Orthodontic Bracket System · Blue Sky Bio · Nov 9, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below. February 21, 2020 LightForce Orthodontics % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K200148 Trade/Device Name: LightForce Orthodontic System (LFO System) Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: PNN, NJM Dated: January 21, 2020 Received: January 22, 2020 Dear Prithul Bom: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ gencies. You must comply with all the Act's Page 2 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) #### K200148 Device Name LightForce Orthodontic System Indications for Use (Describe) The LightForce Orthodontic System is a treatment planning software (TPS) and Orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### TAB 6 - 510(k) Summary # K200148 - 510(k) SUMMARY #### LightForce Orthodontics' LightForce Orthodontic System #### Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared LightForce Orthodontics 1035 Cambridge Street Cambridge, MA 02141 Phone: 800-481-0185 Facsimile: N/A Email: amos@lightforceortho.com Contact Person: Amos N Benninga Date Prepared: February 20, 2020 #### Name of Device and Name/Address of Sponsor LightForce Orthodontic System LightForce Orthodontics 1035 Cambridge Street Cambridge, MA 02141 Trade/Proprietary Name of Device: LightForce Orthodontic System Common or Usual Name: Orthodontic Ceramic Bracket and Accessory Classification Name: Orthodontic Ceramic Bracket, 21CFR§872.5470 Regulatory Class: II Product Code: NJM Primary Predicate: LightForce Orthodontics' LightForce Orthodontic System (K183542) Reference Device: LightForce Orthodontics' LightForce Orthodontic System (K181271) (Note: Previously known as Signature Orthodontic System) {4}------------------------------------------------ #### Device Description and Justification The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring,modifying cases and submitting orders. LightForce Orthodontics' (LFO) operators and the orthodontists use the TPS to generate a prescription of their choosing. LFO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The LFO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth. The change is to upgrade LFO System's Treatment Planning Software (TPS) from version 3.1 to version 4.0. TPS version 3.1 was originally cleared in K183542 and the LFO System was originally cleared in K181271. TPS version 4.0 provides improved software architecture, updated hosting infrastructure and improvements to the user interface to better match the intended use of the product based on customer feedback and validation input. A comparison of TPS 3.1 and TPS 4.0 shows that both software provide the same features and functional workflows is evidence of substantial equivalence. The replacement software is identical in performance and function to the previously used software. #### Indications for Use The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patient-matched orthodontic appliances. #### Comparison to Primary Predicate and Reference Device The LightForce Orthodontic System in the primary predicate (K183542) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. This current submission provides software updates to the software delivered in the primary predicate. The LightForce Orthodontic System in the reference predicate (K181271) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. {5}------------------------------------------------ Note: this current submission (the subject device) is leveraging performance testing such as shear bond strength, torque strength, tensile strength, wire drag force, etc. of the brackets in the reference device, which remain identical in the subject's predicate device, and the subject device. The current submission only differs from the reference device in the software component (Treatment Planning Software / TPS) which has changed. The changes are described and documented in this submission. #### Non-clinical Performance Testing Validation testing of the TPS was performed in accordance with LFO's design control activities for software and to the software's Test Plan. Validation results, Table 6-1, show that the version of the TPS tested performed equivalent to the software component of the primary predicate (K183542). | Table 6-1 - LFO System TPS Performance Testing | | | | | |--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------|--| | LFO System (K181271) | LFO System TPS 3.1 (K183542) | LFO System TPS 4.0 (current submission) | Equivalence Result | | | 4.1 Diagnosis - viewing of patient's digital impression | 4.1 Diagnosis - viewing of patient's digital impression | 4.1 Diagnosis - viewing of patient's digital impression | Equivalent (Test Report) | | | 4.1 Diagnosis - successful diagnosis of patient's malocclusion | 4.1 Diagnosis - successful diagnosis of patient's malocclusion | 4.1 Diagnosis - successful diagnosis of patient's malocclusion | Equivalent (Test Report) | | | 4.2 Planning - successful movement of patient's teeth (within the software) | 4.2 Planning - successful movement of patient's teeth (within the software) | 4.2 Planning - successful movement of patient's teeth (within the software) | Equivalent (Test Report) | | | 4.3 Planning - successful movement of brackets | 4.3 Planning - successful movement of brackets | 4.3 Planning - successful movement of brackets | Equivalent (Test Report) | | | 4.4 Data Handling - case delivered securely and uncorrupted | 4.4 Data Handling - case delivered securely and uncorrupted | 4.4 Data Handling - case delivered securely and uncorrupted | Equivalent (Test Report) | | {6}------------------------------------------------ # Clinical Performance Testing No clinical performance testing was conducted on LFO System brackets. ## Device Comparison Tables The following tables, Table 6-2 and 6-3, provide a comparison of the device features, functions, and performance characteristics between the LightForce Orthodontic System (LFO System) and its predicate devices. | Table 6-2 - LFO System TPS Feature Comparison | | | | | | |---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|------------------------------------------------------------------------------------| | Workflow Function | LFO System (K181271) | LFO System v3.1 (K183542) | LFO System v4.0 (current submission) | Similarities | Differences | | Indications for Use | The LightForce Orthodontic System (K183542) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. | The LightForce Orthodontic System (K183542) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. | The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. | Identical | | | 4.1 Diagnosis - viewing patient's digital impression | Rendering of impression using 3D files | Rendering of impression using 3D files | Rendering of impression using 3D files | Identical | | | 4.1 Diagnosis - viewing patient's digital | Rotate impression display | Rotate impression display | Rotate impression display | Identical | | | impression | | | | | | | 4.1 Diagnosis - viewing patient's digital impression | Zoom impression display | Zoom impression display | Zoom impression display | Identical | | | 4.1 Diagnosis - viewing patient's digital impression | Pan impression display | Pan impression display | Pan impression display | Identical | | | 4.1 Diagnosis - successful diagnosis of patient's malocclusion | Hide/Show individual arches | Hide/Show individual arches | Hide/Show individual arches | Identical | | | 4.2 Planning - move teeth based on desired final location | Rotate & translate around tooth X,Y,Z | Rotate & translate around tooth X,Y,Z | Rotate & translate around tooth X,Y,Z as well as Jaw and TMJ axis | | Improved movemen t accuracy by moving around desired axis. | | 4.3 Planning - move brackets based on desired final location | Move brackets controls | Move brackets controls | Move brackets controls | Identical | | | 4.4 Data Handling - case data delivered securely and uncorrupted | Impression data transmitted over HTTPS | Impression data transmitted over HTTPS | Impression data transmitted over HTTPS | Identical | | {7}------------------------------------------------ {8}------------------------------------------------ | Table 6-3 - Device Comparison | | | | | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Item | Reference Predicate K181271 LightForce Orthodontic System; | Primary Predicate K183542 LightForce Orthodontic System; TPS 3.1 | LightForce Orthodontic System; TPS 4.0 | Comments | | Description | The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient- specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring, and modifying cases. LightForce Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable | The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient- specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring, and modifying cases. LightForce Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable | The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The SO System consists of patient-specific ceramic brackets, patient- specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring, and modifying cases. LightForce Orthodontics' (SO) operators and the orthodontists use the TPS to generate a prescription of their choosing. SO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable | Identical | | | tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth. | tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth. | tooth movement. The SO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth. | | | Product Codes / Regulations | NJM (Orthodontic Ceramic Bracket, 21CFR§872.5470) | NJM (Orthodontic Ceramic Bracket, 21CFR§872.5470) | NJM (Orthodontic Ceramic Bracket, 21CFR§872.5470) | Identical | | Indications for Use | The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. | The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. | The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. | Identical | | Sequence of Treatment Plan or Mode of Use | 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. | 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. | 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. | Identical | | Manufac turing Method | Final desired arrangement of teeth, brackets, wires and jigs are designed with the guidance of LFO internal computer software using a 3-D model of the patient. The Treatment Planning Software allows the clinician to review, measure, and modify the case. Internal LFO software generates the 3D image file that proprietary additive manufacturing equipment uses to create the brackets and indirect bonding (IDB) tray. | Final desired arrangement of teeth, brackets, wires and jigs are designed with the guidance of LFO internal computer software using a 3-D model of the patient. The Treatment Planning Software allows the clinician to review, measure, and modify the case. Internal LFO software generates the 3D image file that proprietary additive manufacturing equipment uses to create the brackets and indirect bonding (IDB) tray. | Final desired arrangement of teeth, brackets, wires and jigs are designed with the guidance of LFO internal computer software using a 3-D model of the patient. The Treatment Planning Software allows the clinician to review, measure, and modify the case. Internal LFO software generates the 3D image file that proprietary additive manufacturing equipment uses to create the brackets and indirect bonding (IDB) tray. | Identical | {9}------------------------------------------------ {10}------------------------------------------------ ### Conclusion The LightForce Orthodontics' LightForce Orthodontics System presented in this 510(k) submission and its primary predicate the LightForce Orthodontic System (K183542) and its reference predicate the LightForce Orthodontics System (K181271) are substantially equivalent in intended use and technological characteristics.