(63 days)
Not Found
No
The summary describes software for orthodontic planning and design, but there is no mention of AI or ML capabilities. The description focuses on user-driven manipulation and design tools.
No.
The "Intended Use" states that it is a "medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options... based on 3D models of the patient's dentition before the start of an orthodontic treatment." It is a software for planning and design, not for treating.
Yes
The "Device Description" section states that the software is "for use by dentists, orthodontists, and trained health care professionals to diagnose and design treatment solutions for patients." This explicitly indicates a diagnostic function for the device.
Yes
The device description explicitly states "Titan Dental Design by ClearAdvance, LLC is an orthodontic appliance design and treatment planning software." It describes functionalities that are purely software-based (uploading scans, manipulating teeth, exporting files) and does not mention any associated hardware components that are part of the medical device itself. The output is files for physical production, which is a separate process.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of Titan Dental Design clearly states its purpose is for orthodontic treatment planning and design based on digital scans of the patient's dentition. It manipulates and analyzes 3D models of teeth.
- No Biological Samples: The device does not involve the analysis of any biological samples taken from the patient. Its input is digital imaging data.
Therefore, Titan Dental Design falls under the category of medical device software used for treatment planning and design, not in vitro diagnostics.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
PNN, LLZ
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Maxilla/Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dentists, orthodontists, and trained health care professionals.
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)
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.
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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, which is a blue square with the letters "FDA" in white. Underneath the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
2
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
3
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
18 ENDEAVOR, STE 107
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
5
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:
Titan Dental Design | Primary Predicate
Device:
3Shape Ortho
System (K152086) | Predicate Device:
BRIUS Planner
Software (K212828) | Comparison
Result |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Regulation Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification Name | Orthodontic Plastic
Bracket (Software) | Orthodontic Plastic
Bracket (Software) | Orthodontic Plastic
Bracket | Same |
| Product Code | PNN, LLZ | PNN, LLZ | PNN | Same |
| Classification | Class II | Class II | Class II | Same |
| Indication 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 | The 3Shape Ortho
System™ ...
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 | BRIUS Planner
Software...
is intended for use
as a medical front-
end device providing
tools for
management of
orthodontic models,
systematic
inspection,
treatment simulation
and virtual appliance
design options
(Patient-Specific
Nitinol Wires | Similar |
| Specification | Proposed Device:
Titan Dental Design | Primary Predicate
Device:
3Shape Ortho
System (K152086) | Predicate Device:
BRIUS Planner
Software (K212828) | Comparison
Result |
| | 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. | Bands, Export of
Models, Indirect
Bonding Transfer
Media) 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. | Sequential Aligners,
Export of Models,
Indirect Bonding
Transfer Media)
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. | The use of the Ortho
System™ 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. | The use of the BRIUS
Planner 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 | |
| Specification | Proposed Device:
Titan Dental Design | Primary Predicate
Device:
3Shape Ortho
System (K152086) | Predicate Device:
BRIUS Planner
Software (K212828) | Comparison
Result |
| Technological
Features | • Stand Alone
Software
• Imports Digital
Dental Scans
• Can be used to
design Dental
Appliances
• Useful for
Diagnosis,
treatment
planning, and
CAD design
• Virtual Planning
of tooth
movement | • Stand Alone
Software
• Imports Digital
Patient Scans
• Can be used to
design Dental
Casts
• Useful for
Diagnosis,
treatment
planning, and CAD
design
• Virtual Planning of
tooth movement | • Stand Alone
Software Module
• Imports Digital
Patient Scans
• Can be used to
design Dental Casts
• Useful for
Diagnosis, treatment
planning, and CAD
design
• Virtual Planning of
tooth movement
• Supports STL Files | Similar |
| Minimum
Hardware/Software
Requirements | • OS: Android:
Firmware Version
8.0 Oreo or higher,
iOS: Firmware
Version 10 or
higher, Windows,
Mac
• RAM: 4 GB RAM
• Video Card: 1 GB
GPU
• Hard Drive Space:
4 GB
• CPU: 2.6 GHz
• Web browser
(Titan Dental
Design):
Windows: .exe,
Mac: .pkg,
Android: .apk,
IOS: .ipa
• Internet Access | • OS: Windows 7, 8,
64-bit
• RAM: 8 GB
• Video Card
Memory: 1 GB
GeForce
• Hard Drive Space:
250 GB
• CPU: Intel Core i5
or equivalent
• Network Internet
Connection
• Mouse: with
wheel button | • OS: Windows 10
64-bit
• RAM: 8 GB
• Monitor
Resolution:1280 X
800
• Video Card
Memory: 1 GB
• Hard Drive Space:
10 GB
• CPU: Intel
compatible 2.6
GHz/Dual or Quad
core 2.6 GHz
• Mouse: Any Mouse
with scrolling wheel
or button | Similar |
| Login Method | Username and
password | Username and
password | Username and
password | Same |
| Supported
Anatomic Areas | Maxilla/Mandible | Maxilla/Mandible | Maxilla/Mandible | Same |
| Intended Use | | | | |
| Specification | Proposed Device:
Titan Dental Design | Primary Predicate
Device:
3Shape Ortho
System (K152086) | Predicate Device:
BRIUS Planner
Software (K212828) | Comparison
Result |
| Managing Patient
and case base data | Yes | Yes | Yes | Same |
| Collection of study
material | Yes | Yes | Yes | Same |
| Alignment of study
material | Yes | Yes | Yes | Same |
| Measuring study
material | Yes | Yes | Yes | Same |
| Analyzing study
material | Yes | Yes | Yes | Same |
| Treatment
simulation | Yes | Yes | Yes | Same |
| Virtual appliance
design | Yes | Yes | Yes | Same |
| Surface scan for
intraoral scanner | Yes | Yes | Yes | Same |
| Surface scan from
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
simulation | Yes | Yes | Yes | Same |
| Orthodontic | Yes | Yes | Yes | Same |
| Appliance virtual
preparation | Yes | Yes | Yes | Same |
| Orthodontic
appliance design | Yes | Yes | Yes | Same |
| Orthodontic
appliance export | Yes | Yes | Yes | Same |
| Creating, editing,
and copying patient
data | Yes | Yes | Yes | Same |
| Creating, editing,
and copying case | Yes | Yes | Yes | Same |
| Specification | Proposed Device: Titan Dental Design | Primary Predicate Device:
3Shape Ortho System (K152086) | Predicate Device:
BRIUS Planner Software (K212828) | Comparison Result |
| data | | | | |
Table 5 Device Comparison Table
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7
8
9
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)