Who is the manufacturer of PlaniMax Orthodontic Software?

Choice Biotech, Inc. filed the 510(k) submission for PlaniMax Orthodontic Software (K201036).

What is the FDA product code for PlaniMax Orthodontic Software?

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

What is the regulatory pathway for PlaniMax Orthodontic Software?

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

Who can help prepare an FDA 510(k) submission like PlaniMax Orthodontic Software?

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.

PlaniMax Orthodontic Software

Q: What are the predicate devices for PlaniMax Orthodontic Software?

Ortho System from 3Shape A/S (K171634).

K201036 · Choice Biotech, Inc. · PNN · Dec 22, 2020 · Dental

Device Facts

Record ID	K201036
Device Name	PlaniMax Orthodontic Software
Applicant	Choice Biotech, Inc.
Product Code	PNN · Dental
Decision Date	Dec 22, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5470
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are based 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 the PlaniMax 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

PlaniMax is a standalone orthodontic software tool for managing 3D scanned dental models (STL files). It enables clinicians to perform systematic inspection, detailed analysis, and virtual treatment planning by simulating tooth movements. The software supports the design of orthodontic appliances, including dental casts for sequential aligners or retainers. Used in clinical settings by trained orthodontic professionals, the software provides visualization and measurement tools (arch shape, wire length, tooth width, Bolton analysis, space analysis, overjet/overbite, occlusion map) to assist in diagnosis and treatment progress monitoring. Clinicians use the output to plan and evaluate treatment objectives. The device benefits patients by facilitating customized orthodontic appliance design and monitoring treatment efficacy.

Clinical Evidence

No clinical data. Bench testing only, including software, hardware, and integration verification and validation testing.

Technological Characteristics

Standalone software module; supports STL file import; Windows OS; requires minimum 4GB RAM, 100GB HDD, and Intel Core i3 processor. Features include 3D model visualization, measurement tools, and virtual treatment simulation. No CT/DICOM support. Software validation performed per FDA guidance.

Indications for Use

Indicated for orthodontic patients requiring management of dental models, inspection, analysis, treatment simulation, and virtual appliance design (aligners/retainers). Applicable before, during, and at the end of orthodontic treatment. Requires trained orthodontic professionals.

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

Ortho System from 3Shape A/S (K171634)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. December 22, 2020 Choice Biotech Inc. Tyler Kuo RD Vice President Rm. C. 4F. No.13. Nanke 3rd Rd., Xinshi Dist. Tainan City, 74147 Taiwan ### Re: K201036 Trade/Device Name: PlaniMax Orthodontic Software Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN Dated: July 20, 2020 Received: July 27, 2020 Dear Tyler Kuo: 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 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 {1}------------------------------------------------ 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, Michael E. Adjodha, M.ChE. Assistant 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}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K201036 Device Name PlaniMax #### Indications for Use (Describe) The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are based 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 the PlaniMax 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) #### 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for CHOICE Biotech. The word "CHOICE" is written in a stylized font, with the "O" replaced by a circle with a plus sign inside. To the right of "CHOICE" is the word "Biotech", with some smaller Chinese characters above it. The logo is in a dark color, possibly black or dark blue, against a white background. ## 510(k) Summary This summary of 510(k) safety and effectiveness information in accordance with the requirements of Safe Medical Device Act (SMDA) of 1990 and Title 21 CFR 807.92. The assigned 510(k) number is_K201036 | Submitter: | CHOICE BIOTECH INC. Rm. C, 4F, No.13, Nanke 3rd Rd., Xinshi Dist., Tainan City 74147, Taiwan Phone: +886-6-505-7289 Fax: +886-6-505-7301 | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Tyler Kuo / RD Vice President Email: tylerkuo@mail.wearechoice.com Phone: +886-6-505-7289 | | Date Prepared: | December 21st, 2020 | | Proprietary Name: | PlaniMax Orthodontic Software | | Common Name: | Orthodontic Plastic Bracket (Software) | | CFR Classification: | 21 CFR 872.5470 | | Device Class: | II | | Product Code: | PNN | | Panel: | Dental | | Primary Predicate: | Ortho System from 3ShapeA/S (K171634) | {4}------------------------------------------------ #### Device Description: The PlaniMax Orthodontic Software for dental retainers and dental cast for sequential aligners is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models , virtual planning of orthodontic treatments by simulating tooth movements , and design of orthodontic appliances based on 3D scanned orthodontic models. #### Indications for Use: The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 the PlaniMax 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. #### Summary of the technological characteristics: PlaniMax Orthodontic Software is functionally equivalent to the following predicate device: Ortho System (K171634) cleared January 17th, 2018. The following tables demonstrates the intended uses and technical characteristics of PlaniMax Orthodontic Software are substantially equivalent to the predicate devices. {5}------------------------------------------------ # CHOICE Functional Specification Comparison Table for the PlaniMax Software and Ortho System (K171634) : | Specification | PlaniMax | Ortho System (K171634) | Comparison Result | |------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The PlaniMax Orthodontic Software is indicated for use as a front-end software tool for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options, including dental casts, which may be used for sequential aligner trays or retainers. These applications are 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 the PlaniMax 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 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 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. 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. | Similar. Compare to the predicate device, the virtual appliance design options of PlaniMax is including dental casts, which may be used for sequential aligner trays or retainers. | | Technology Features | • 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 | • 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 | Same. | | Minimum Hardware/ Software Requirements | • OS: Windows 7 32-bit or later • RAM: 4 GB • Monitor Resolution: 1024 X 768 • Video Card Memory: 1 GB • Hard Drive Space: 100 GB • CPU: Intel Core i3 or equivalent • Network: Network Internet connection • Mouse: Any Mouse with scrolling wheel or button | • OS: Windows 7, 8 or 10 64-bit • RAM: 8 GB • Monitor Resolution: 1280 X 800 • Video Card Memory: 1 GB • Hard Drive Space: 250 GB • CPU: Intel Core i5 or equivalent • Network: Network Internet connection • Mouse: Any Mouse with scrolling wheel or button | Similar. No effect to the indications for use. | | Feature | PlaniMax | Ortho System (K171634) | | | Supported anatomic | Maxilla/Mandible | Maxilla/Mandible | | | Intended Use | | | | | Managing Patient and case base data | Yes | Yes | | | Collection of study material | Yes | Yes | | | Alignment of study material | Yes | Yes | | | Measuring study material | Yes | Yes | | | Analyzing Study material | Yes | Yes | | | Treatment Simulation | Yes | Yes | | | Virtual Appliance Design | Yes | Yes | | | Managing patient and case base data | | | | | Creating, editing, deleting and copying patient data | Yes | Yes | | | Creating, editing, deleting and copying case data | Yes | Yes | | | Collection of study material | | | | | Surface scan for intraoral scanner | Yes | Yes | | | Surface scan from STL file | Yes | Yes | | | CT image data (DICOM) | No | Yes | | | 2D overlay (PNG, JPG, BMP) | Yes | Yes | | | Alignment of study material | | | | | Aligning surface scan and CT image | No | Yes | | | Aligning Cephalometric Images | Yes | Yes | | | Alignment of 2D overlays | Yes | Yes | | | Ability to check/adjust DICOM visibility | No | Yes | | | DICOM scan Segmentation | No | No | | | Measuring study material | | | | | 2D Measurement tool box | Yes | Yes | | | 3D Measurement tool box | Yes | Yes | | | Analyzing study material |…