(30 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the software upgrade as providing improved architecture, infrastructure, and user interface, not new AI/ML capabilities. The comparison to the predicate device emphasizes identical performance and function.
Yes
The device is described as an "orthodontic appliance system used to correct malocclusions in orthodontic patients," which directly indicates its role in treating a medical condition rather than solely diagnosing or providing information.
No
The device is described as a "treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions." Its primary function is to plan and implement orthodontic treatment, not to diagnose a condition.
No
The device description explicitly states that the LightForce Orthodontic System consists of both treatment planning software (TPS) and physical components, including patient-specific ceramic brackets and placement jigs. While the submission focuses on a software upgrade, the overall system is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The LightForce Orthodontic System is described as a treatment planning software and orthodontic appliance system used to correct malocclusions (misaligned teeth) using patient-matched appliances. It works with digital impressions of teeth and involves bonding brackets to the teeth.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient. The system uses digital data (3D files from digital impressions) and physical components (brackets, jigs, wires) to directly treat a physical condition (malocclusion).
Therefore, the LightForce Orthodontic System falls under the category of a therapeutic device used for correcting a physical condition, not an IVD used for analyzing biological specimens.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
PNN, NJM
Device 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Rendering of impression using 3D files.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
LightForce Orthodontics' (LFO) operators and the orthodontists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 show that the version of the TPS tested performed equivalent to the software component of the primary predicate (K183542).
Key results show equivalence for:
- Diagnosis - viewing of patient's digital impression
- Diagnosis - successful diagnosis of patient's malocclusion
- Planning - successful movement of patient's teeth (within the software)
- Planning - successful movement of brackets
- Data Handling - case delivered securely and uncorrupted
Clinical Performance Testing:
No clinical performance testing was conducted on LFO System brackets.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
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.(b)
Classification. Class II.
0
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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) |
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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.