HDH Treatment Planning System

K212173 · Cdb Corporation · PNN · Jan 25, 2022 · Dental

Device Facts

• Record ID: K212173
• Device Name: HDH Treatment Planning System
• Applicant: Cdb Corporation
• Product Code: PNN · Dental
• Decision Date: Jan 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

The HDH Treatment Planning 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition. The use of the HDH Treatment Planning System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

Device Story

HDH Treatment Planning System is a software-based tool for dental professionals; imports 3D digital scans of patient dentition (from intra-oral scans or analog impressions); enables systematic inspection, measurement, and simulation of tooth movements; allows virtual design of dental casts for sequential aligner trays or retainers. Output is exported as STL or OBJ files for fabrication. Used in clinical settings by orthodontists/dental professionals; assists in developing virtual treatment plans; facilitates orthodontic diagnosis and treatment simulation; benefits patients by enabling customized, sequential orthodontic appliance design.

Clinical Evidence

No clinical data performed; bench testing only. Software verification and validation testing conducted per FDA guidance; all results met acceptance criteria.

Technological Characteristics

Software-based device programmed in C++. Hardware requirements: Windows 8/10 (64-bit), >=8GB RAM, >=1GB video memory, 10GB HDD, Intel Core i5 2500 or equivalent, network connection. Operates on standard PC hardware. No specific material standards or sterilization methods applicable as it is a non-patient-contact software device.

Indications for Use

Indicated for use by trained dental professionals for orthodontic treatment planning, including management of orthodontic models, inspection, analysis, treatment simulation, and virtual design of dental casts for sequential aligner trays or retainers in patients requiring orthodontic care.

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

• 3Shape Ortho System (K152086)

Reference Devices

• HIT Clear Aligner (K210613)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 25, 2022

CDB Corporation Leah Lehman Senior Operations Manager 9201 Industrial Boulevard, NE Leland, North Carolina 28451

Re: K212173

Trade/Device Name: HDH Treatment Planning System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: December 29, 2021 Received: January 4, 2022

Dear Leah Lehman:

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

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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 (OS) 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. 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) K212173

Device Name HDH Treatment Planning System

#### Indications for Use (Describe)

The HDH Treatment Planning 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition. The use of the HDH Treatment Planning System requires the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-family: Arial, sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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Image /page/3/Picture/2 description: The image shows the logo for CDB Ceramic Dental Brackets, followed by the text "510(k) Summary" in a large, bold font. The logo consists of a stylized blue shape resembling a stylized letter "E" or a series of overlapping triangles. The text "CDB" is in a sans-serif font, with the words "CERAMIC DENTAL BRACKETS" written in a smaller font size below it.

This 510(k) Summary is submitted in accordance with the requirements of 21CFR 807.92

- Submitter: CDB Corporation 9201 Industrial Blvd, NE Leland, NC 28451 USA Owner/Operator No.: 9002860 Establishment Registration No.: 1054415 Primary Contact: Leah M Lehman Senior Operations Manager Phone: [phone] [e-mail] Secondary Contact: Herbert Haas Managing Director Phone: [phone] [e-mail]

| Date Prepared: | January 12, 2022 |
|-----------------------------|-----------------------------------------------------------------------------|
| 510k Submission: | K212173 |
| Device Name: | HDH Treatment Planning System |
| CFR Classification: | 21 CRF 872.5470 |
| Device Classification Name: | Orthodontic Plastic Bracket |
| Product Code: | PNN (Orthodontic Software),<br>LLZ (System, image processing, radiological) |
| Common Name: | Orthodontic Treatment Planning & Diagnosis Software |
| Classification: | Medical Device, Class II |

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# Indications for Use:

The HDH Treatment Planning 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition. The use of the HDH Treatment Planning System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.

### Predicate Device:

3Shape Ortho System, 3Shape A/S, K152086 (primary predicate) HIT Clear Aligner, CDB Corporation, K210613 (reference device)

### Device Description:

The HDH Treatment Planning system is a software system for orthodontic diagnosis and treatment simulation utilized by dental professionals. The software imports patient 3D digital scans serving as a base for diagnosing the orthodontic treatment needs, analyzing, inspecting, measuring, and simulating tooth movements, and allows the user to develop a virtual treatment plan. The output of the treatment plan may be downloaded as files in STL format, a standard stereolithographic file format, or OBJ format, a standard 3D image format, for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.

### Technological characteristics:

The HDH Treatment Planning system is a software device programmed in C++ with the following hardware requirements:

| Item | Minimum Requirements |
|----------------------|----------------------------------|
| OS: | Windows 8 or 10, 64 bit |
| RAM: | >=8 GB |
| Monitor Resolution: | 1280x800 |
| Video Card Memory: | >=1GB |
| Available HDD Space: | 10 GB |
| CPU: | Intel core i5 2500 or equivalent |
| Network: | Network Internet connection |
| Mouse: | With the wheel button |

The above hardware requirements are found to be substantially equivalent to the requirements of 3Shape Ortho System ™, FDA cleared per K152086.

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## Performance Data:

Software verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005).

All test results met acceptance criteria, demonstrating the HDH Treatment Planning System performs as intended and is substantially equivalent to the predicate devices.

## Substantial Equivalence Discussion:

The following table compares the HDH Treatment Planning System to the predicate device, 3Shape Ortho System ™, with respect to indications for use, technological characteristics, and principles of operation. The reference device, HIT Clear Aligner, is also presented in the comparison table.

| Feature | HDH Treatment<br>Planning System<br>Submission Device | 3Shape Ortho System™<br>Predicate Device | HIT Clear Aligner<br>Reference Device |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212173 | K152086 | K210613 |
| Manufacturer | CDB Corporation | 3Shape A/S | CDB Corporation |
| Regulation<br>Number | 872.5470 | 872.5470 | 872.5470 |
| Device<br>Classification<br>Name | Orthodontic Plastic<br>Bracket | Orthodontic Plastic Bracket | Orthodontic Plastic<br>Bracket |
| Product Code | PNN (Orthodontic<br>Software)<br>LLZ (System, image<br>processing, radiological) | PNN (Orthodontic Software)<br>LLZ (System, image<br>processing, radiological) | NXC<br>(Aligner, Sequential) |
| Common Name | Orthodontic Treatment<br>Planning and Diagnosis<br>Software | Orthodontic Treatment<br>Planning and Diagnosis<br>Software | Aligner, Sequential |
| Device Class | II | II | II |
| Indications for<br>Use | The HDH Treatment<br>Planning System is<br>intended for use as a<br>medical front-end device<br>providing tools for<br>management of<br>orthodontic models,<br>systematic inspection,<br>detailed analysis,<br>treatment simulation and<br>virtual design of a series<br>of dental casts, which<br>may be used for | 3Shape Ortho System™ is<br>intended for use as a<br>medical front-end device<br>providing tools for<br>management of orthodontic<br>models, systematic<br>inspection, detailed<br>analysis, treatment<br>simulation and virtual<br>appliance design options<br>(Custom Metal Bands,<br>Export of Models, Indirect<br>Bonding Transfer Media) | The HIT Clear<br>Aligner system is<br>indicated for the<br>treatment of<br>malocclusion in<br>patients with<br>permanent dentition.<br>The HIT Clear<br>Aligner system<br>positions teeth by<br>way of continuous<br>gentle force. |
| | sequential aligner trays or<br>retainers, based on 3D<br>models of the patient's<br>dentition. The use of the<br>HDH Treatment Planning<br>System requires the user<br>to have the necessary<br>training and domain<br>knowledge in the practice<br>of orthodontics, as well to<br>have received a<br>dedicated training in the<br>use of the software. | based on 3D models of the<br>patient's dentition before the<br>start of an orthodontic<br>treatment. It can also be<br>applied during the treatment<br>to inspect and analyze the<br>progress of the treatment. It<br>can be used at the end of<br>the treatment to evaluate if<br>the outcome is consistent<br>with the planned/desired<br>treatment objectives.<br>The use of the Ortho<br>System™ requires the user<br>to have the necessary<br>training and domain<br>knowledge in the practice of<br>orthodontics, as well as to<br>have received a<br>dedicated training in the use<br>of the software. | |
| Operating<br>principle | The software provides<br>calculation displaying the<br>recommended sequential<br>aligners staging on the<br>patient's teeth, based on<br>the pre-treatment 3D<br>scanned orthodontic<br>model, clinician-<br>prescribed treatment<br>objective and clinician's<br>general pre-treatment<br>preferences. | The software provides<br>calculation displaying virtual<br>appliance design options<br>based on 3D models of a<br>patient's dentition. | Alignment of teeth<br>by sequential use of<br>preformed plastic<br>trays. |
| Key records | 3D models are generated<br>from scanned analog<br>impressions or directly<br>from an intra-oral scan. | 3D scanned orthodontic<br>models | From the software<br>part: 3D models are<br>generated from<br>scanned analog<br>impressions or<br>directly from an<br>intra-oral scan. |
| Software end<br>product | Dental casts | Custom metal bands,<br>indirect bonding transfer<br>trays and<br>dental casts | Dental casts |
| Application of<br>digital imaging<br>tools based on<br>3D orthodontic<br>models for<br>orthodontic case<br>archiving,<br>diagnosis,<br>treatment<br>planning and<br>CAD design | Yes | Yes | Yes |
| Virtual planning<br>of orthodontic<br>treatments<br>simulating tooth<br>movements | Yes | Yes | Yes |
| Supported types<br>of digital data | STL, OBJ | DICOM, STL, JPG, BMP,<br>PNG | STL, OBJ |
| OTC or Rx | Rx | Rx | Rx |

### Table 1. Predicate Device Information Comparison

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The software output for the predicate device is represented by custom metal bands, indirect bonding transfer trays and dental casts, whereas the subject device designs only dental casts.

### Clinical Testing:

Clinical testing is not a requirement and has not been performed.

## Substantial Equivalence Conclusion:

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device. The subject and the primary predicate devices share intended use including software used by dental professionals in orthodontic treatment planning for management of patients and orthodontic models, inspection, measurement and analysis of the models, treatment simulation, preparation and export of a series of virtual dental casts. The subject and the primary predicate devices share the same operating principle.

The software output for the predicate device is represented by custom metal bands, indirect bonding transfer trays and dental casts, whereas the subject device designs only dental casts. The difference in the software output along with the supported types of digital data is insignificant and do not require further testing to ensure the correct product operation; thus, the difference does not affect safety or efficacy of the subject device.

The subject and predicate devices share digital imaging tools based on 3D orthodontic models for orthodontic case archiving, diagnosis, treatment planning and CAD design, and virtual planning of orthodontic treatments simulating tooth movements.

Performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness.

The conclusion drawn from the data included in this submission demonstrates that the HDH Treatment Planning system is substantially equivalent to the cleared predicate device.

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