Titan Dental Design
Device Facts
| Record ID | K232429 |
|---|---|
| Device Name | Titan Dental Design |
| Applicant | Clearadvance, LLC |
| Product Code | PNN · Dental |
| Decision Date | Oct 13, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5470 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
Titan Dental Design is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of Titan Dental Design requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
Device Story
Titan Dental Design is orthodontic treatment planning software; inputs digital 3D dental scans; allows clinicians to manipulate/move teeth to create treatment plans for malocclusion; outputs files for physical production of appliances (e.g., sequential aligners) via 3D printing. Used in clinical settings by orthodontists/dentists; facilitates diagnosis, treatment simulation, and virtual appliance design. Clinicians use output to guide orthodontic therapy and evaluate treatment progress/outcomes. Benefits include improved treatment planning accuracy and streamlined appliance fabrication.
Clinical Evidence
Bench testing only. Software underwent integration, verification, and validation testing per FDA guidance for software in medical devices. No clinical data provided.
Technological Characteristics
Standalone software; imports digital dental scans (STL); supports virtual tooth movement and CAD design for orthodontic appliances. Compatible with Android (8.0+), iOS (10+), Windows, and Mac. Requires 4GB RAM, 1GB GPU, 4GB hard drive space, and 2.6 GHz CPU. Connectivity via internet access. Login via username/password.
Indications for Use
Indicated for use by dentists, orthodontists, and trained healthcare professionals for management of orthodontic models, inspection, analysis, treatment simulation, and virtual appliance design (e.g., sequential aligners, indirect bonding transfer media) based on 3D dental scans. Applicable before, during, and at the end of orthodontic treatment to evaluate outcomes.
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
Submission Summary (Full Text)
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October 13, 2023
ClearAdvance, LLC % Logan Simmons Regulatory Affairs Consultant Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, Texas 77043
Re: K232429
Trade/Device Name: Titan Dental Design Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: August 11, 2023 Received: August 11, 2023
Dear Logan Simmons:
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 (the 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 available 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.
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#### 2 K232429 - Logan Simmons
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
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Sincerely,
MichaeFE. Adjodha -S
Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known)
#### K232429
Device Name Titan Dental Design
### Indications for Use (Describe)
Titan Dental Design is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of Titan Dental Design requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# Section 5. 510(k) Summary
# K232429
### 510(k) SUMMARY
A summary of 510(k) safety and effectiveness information for this traditional 510(k) in accordance with the requirements of 21 CFR 807.92.
| Submitter: | CLEARADVANCE, LLC<br>18 ENDEAVOR, STE 107<br>IRVINE, CA 92618 |
|---------------------------|---------------------------------------------------------------|
| Company Contact Person: | Frank Puig, Co-Founder, ClearAdvance, LLC |
| Phone: | 614-260-9849 |
| Email: | Frank.Puig@gmail.com |
| Submission Correspondent: | Logan Simmons, Regulatory Affairs Consultant |
| Address: | 1321 Upland Dr. Suite 6792 Houston, TX 77043 |
| Phone: | 440-387-9788 |
| Email: | lsimmons@primepathmedtech.com |
| Date Prepared: | August 1, 2023 |
| Proprietary Name: | Titan Dental Design |
| Common Name: | Orthodontic Plastic Bracket (Software) |
| Product Code: | PNN – Orthodontic plastic bracket (Software), LLZ |
| Device Classification: | Class II, 21 CFR 872.5470 |
| Primary Predicate Device: | 3Shape Ortho System (K152086) |
| Second Predicate Device: | Brius Planner Software (K212828) |
### Device Description:
Titan Dental Design by ClearAdvance, LLC is an orthodontic appliance design and treatment planning software. This software is for use by dentists, orthodontists, and trained health care professionals to diagnose and design treatment solutions for patients. The Titan Dental Design software allows users to upload digital scans of patient's dentition to the system, manipulate and move teeth in the dentition scan
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to create treatment plans for malocclusion, and export or send treatment planning files for physical production of orthodontic appliances such as thermoplastic aligners with the use of 3D printers.
### Indications for Use:
Titan Dental Design is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media, Sequential aligners) based on 3D models of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.
The use of Titan Dental Design requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.
### Comparison to Predicate Devices:
The Proposed Device is functionally equivalent to the following devices: 3Shape Ortho System (K152086, cleared April 28, 2016) and Brius Planner Software (K212828, cleared 10/01/2021). The following table demonstrates the functional specifications of the Proposed Device are substantially equivalent to the Predicate Devices and raises no questions regarding safety and effectiveness of the device.
| Specification | Proposed Device:<br>Titan Dental Design | Primary Predicate<br>Device:<br>3Shape Ortho<br>System (K152086) | Predicate Device:<br>BRIUS Planner<br>Software (K212828) | Comparison<br>Result |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Regulation Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification Name | Orthodontic Plastic<br>Bracket (Software) | Orthodontic Plastic<br>Bracket (Software) | Orthodontic Plastic<br>Bracket | Same |
| Product Code | PNN, LLZ | PNN, LLZ | PNN | Same |
| Classification | Class II | Class II | Class II | Same |
| Indication for Use | Titan Dental<br>Design...<br>is intended for use<br>as a medical front-<br>end device providing<br>tools for<br>management of<br>orthodontic models,<br>systematic<br>inspection, detailed<br>analysis, treatment<br>simulation and<br>virtual appliance<br>design options<br>(Export of Models | The 3Shape Ortho<br>System™ ...<br>is intended for use<br>as a medical front-<br>end device providing<br>tools for<br>management of<br>orthodontic models,<br>systematic<br>inspection, detailed<br>analysis, treatment<br>simulation and<br>virtual appliance<br>design options<br>(Custom Metal | BRIUS Planner<br>Software...<br>is intended for use<br>as a medical front-<br>end device providing<br>tools for<br>management of<br>orthodontic models,<br>systematic<br>inspection,<br>treatment simulation<br>and virtual appliance<br>design options<br>(Patient-Specific<br>Nitinol Wires | Similar |
| Specification | Proposed Device:<br>Titan Dental Design | Primary Predicate<br>Device:<br>3Shape Ortho<br>System (K152086) | Predicate Device:<br>BRIUS Planner<br>Software (K212828) | Comparison<br>Result |
| | Indirect Bonding<br>Transfer Media,<br>Sequential aligners)<br>based on 3D models<br>of the patient's<br>dentition before the<br>start of an<br>orthodontic<br>treatment. It can<br>also be applied<br>during the treatment<br>to inspect and<br>analyze the progress<br>of the treatment. It<br>can be used at the<br>end of the treatment<br>to evaluate if the<br>outcome is<br>consistent with the<br>planned/desired<br>treatment<br>objectives. | Bands, Export of<br>Models, Indirect<br>Bonding Transfer<br>Media) based on 3D<br>models of the<br>patient's dentition<br>before the start of<br>an orthodontic<br>treatment. It can<br>also be applied<br>during the<br>treatment to inspect<br>and analyze the<br>progress of the<br>treatment. It can be<br>used at the end of<br>the treatment to<br>evaluate if the<br>outcome is<br>consistent with the<br>planned/desired<br>treatment<br>objectives. | Sequential Aligners,<br>Export of Models,<br>Indirect Bonding<br>Transfer Media)<br>based on 3D models<br>of the patient's<br>dentition before the<br>start of an<br>orthodontic<br>treatment. It can also<br>be applied during the<br>treatment to inspect<br>and analyze the<br>progress of the<br>treatment. It can be<br>used at the end of<br>the treatment to<br>evaluate if the<br>outcome is<br>consistent with the<br>planned/desired<br>treatment objectives. | |
| | The use of Titan<br>Dental Design<br>requires the user to<br>have the necessary<br>training and domain<br>knowledge in the<br>practice of<br>orthodontics, as well<br>as to have received a<br>dedicated training in<br>the use of the<br>software. | The use of the Ortho<br>System™ requires<br>the user to have the<br>necessary training<br>and domain<br>knowledge in the<br>practice of<br>orthodontics, as well<br>as to have received a<br>dedicated training in<br>the use of the<br>software. | The use of the BRIUS<br>Planner requires the<br>user to have the<br>necessary training<br>and domain<br>knowledge in the<br>practice of<br>orthodontics, as well<br>as to have received a<br>dedicated training in<br>the use of the<br>software | |
| Specification | Proposed Device:<br>Titan Dental Design | Primary Predicate<br>Device:<br>3Shape Ortho<br>System (K152086) | Predicate Device:<br>BRIUS Planner<br>Software (K212828) | Comparison<br>Result |
| Technological<br>Features | • Stand Alone<br>Software<br>• Imports Digital<br>Dental Scans<br>• Can be used to<br>design Dental<br>Appliances<br>• Useful for<br>Diagnosis,<br>treatment<br>planning, and<br>CAD design<br>• Virtual Planning<br>of tooth<br>movement | • Stand Alone<br>Software<br>• Imports Digital<br>Patient Scans<br>• Can be used to<br>design Dental<br>Casts<br>• Useful for<br>Diagnosis,<br>treatment<br>planning, and CAD<br>design<br>• Virtual Planning of<br>tooth movement | • Stand Alone<br>Software Module<br>• Imports Digital<br>Patient Scans<br>• Can be used to<br>design Dental Casts<br>• Useful for<br>Diagnosis, treatment<br>planning, and CAD<br>design<br>• Virtual Planning of<br>tooth movement<br>• Supports STL Files | Similar |
| Minimum<br>Hardware/Software<br>Requirements | • OS: Android:<br>Firmware Version<br>8.0 Oreo or higher,<br>iOS: Firmware<br>Version 10 or<br>higher, Windows,<br>Mac<br>• RAM: 4 GB RAM<br>• Video Card: 1 GB<br>GPU<br>• Hard Drive Space:<br>4 GB<br>• CPU: 2.6 GHz<br>• Web browser<br>(Titan Dental<br>Design):<br>Windows: .exe,<br>Mac: .pkg,<br>Android: .apk,<br>IOS: .ipa<br>• Internet Access | • OS: Windows 7, 8,<br>64-bit<br>• RAM: 8 GB<br>• Video Card<br>Memory: 1 GB<br>GeForce<br>• Hard Drive Space:<br>250 GB<br>• CPU: Intel Core i5<br>or equivalent<br>• Network Internet<br>Connection<br>• Mouse: with<br>wheel button | • OS: Windows 10<br>64-bit<br>• RAM: 8 GB<br>• Monitor<br>Resolution:1280 X<br>800<br>• Video Card<br>Memory: 1 GB<br>• Hard Drive Space:<br>10 GB<br>• CPU: Intel<br>compatible 2.6<br>GHz/Dual or Quad<br>core 2.6 GHz<br>• Mouse: Any Mouse<br>with scrolling wheel<br>or button | Similar |
| Login Method | Username and<br>password | Username and<br>password | Username and<br>password | Same |
| Supported<br>Anatomic Areas | Maxilla/Mandible | Maxilla/Mandible | Maxilla/Mandible | Same |
| Intended Use | | | | |
| Specification | Proposed Device:<br>Titan Dental Design | Primary Predicate<br>Device:<br>3Shape Ortho<br>System (K152086) | Predicate Device:<br>BRIUS Planner<br>Software (K212828) | Comparison<br>Result |
| Managing Patient<br>and case base data | Yes | Yes | Yes | Same |
| Collection of study<br>material | Yes | Yes | Yes | Same |
| Alignment of study<br>material | Yes | Yes | Yes | Same |
| Measuring study<br>material | Yes | Yes | Yes | Same |
| Analyzing study<br>material | Yes | Yes | Yes | Same |
| Treatment<br>simulation | Yes | Yes | Yes | Same |
| Virtual appliance<br>design | Yes | Yes | Yes | Same |
| Surface scan for<br>intraoral scanner | Yes | Yes | Yes | Same |
| Surface scan from<br>STL file | Yes | Yes | Yes | Same |
| Arch shape | Yes | Yes | Yes | Same |
| Overbite/overjet | Yes | Yes | Yes | Same |
| Occlusal map | Yes | Yes | Yes | Same |
| 3D treatment<br>simulation | Yes | Yes | Yes | Same |
| Orthodontic | Yes | Yes | Yes | Same |
| Appliance virtual<br>preparation | Yes | Yes | Yes | Same |
| Orthodontic<br>appliance design | Yes | Yes | Yes | Same |
| Orthodontic<br>appliance export | Yes | Yes | Yes | Same |
| Creating, editing,<br>and copying patient<br>data | Yes | Yes | Yes | Same |
| Creating, editing,<br>and copying case | Yes | Yes | Yes | Same |
| Specification | Proposed Device: Titan Dental Design | Primary Predicate Device:<br>3Shape Ortho System (K152086) | Predicate Device:<br>BRIUS Planner Software (K212828) | Comparison Result |
| data | | | | |
Table 5 Device Comparison Table
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### Comparison of Indications for Use to the Predicate Devices:
Based on the above comparison, the indications of use of the Proposed Device is similar to that of the Predicate Devices. The alteration of indication for use statement to the Predicate Device (3Shape Ortho System, K152086) within this 510(k) submission of the Proposed Device is "intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Custom Metal Bands, Export of Models, Indirect Bonding Transfer Media) based on 3D models of the patient's dentition before the start of an orthodontic treatment". The proposed device, Titan Dental Design, manufactures sequential aligners, rather than Custom Metal Bands like those manufactured by the Predicate Device. However, the secondary Predicate Device's (Brius Planner Software, K212828), indication for use statement matches the indications for use statement of the Proposed Device in that it lists Sequential Aligners as one of its "virtual appliance design options",
Based on the similarity of indication for use, the Proposed Device can be considered substantially equivalent to the Predicate Devices.
### Comparison of Technological Characteristics to Predicate Devices:
Based on the above comparisons, the design, construction, and performance characteristics of the Proposed Device are similar to that of the Predicate Devices. The differences identified are not substantial differences in operation of the device. Thus, the Proposed Device can be considered substantially equivalent to the Predicate Devices.
### Summary of Performance Data and Substantial Equivalence
Utilizing FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2015) the Proposed Device, Titan Dental Design underwent appropriate integration, verification, and validation testing. The software passed the testing and performed per its intended use.
### Conclusion:
Based on comparison of indications for use, technological features, performance testing, and software validation testing, the Proposed Device, Titan Dental Design, has been shown to be appropriate for its indications for use and is substantially equivalent to the legally marketed Predicate Devices, 3Shape Ortho System (K152086) and Brius Planning Software (K212828)
