AUTOLIGN

K192847 · Diorco Co., Ltd. · PNN · Jul 21, 2020 · Dental

Device Facts

• Record ID: K192847
• Device Name: AUTOLIGN
• Applicant: Diorco Co., Ltd.
• Product Code: PNN · Dental
• Decision Date: Jul 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The AUTOLIGN 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) 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 AUTOLIGN 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

AUTOLIGN is stand-alone software for orthodontic treatment planning; inputs include 3D dental models derived from intraoral cameras or desktop laboratory scanners (STL files). Software enables segmentation, editing, and analysis of 3D virtual dental models; performs measurements (e.g., Bolton analysis); facilitates treatment simulation and virtual appliance design. Output consists of digital models and analysis data exported to orthodontic laboratories or manufacturers for appliance production (e.g., sequential aligners). Used in clinical settings by orthodontists or trained dental professionals. Software aids clinical decision-making by providing tools for systematic inspection and progress evaluation, potentially improving treatment planning accuracy and patient outcomes.

Clinical Evidence

Bench testing only. Software verification and validation testing conducted per FDA guidance. No clinical data provided.

Technological Characteristics

Stand-alone software module; imports STL files; supports 3D virtual dental model creation, segmentation, and analysis. No patient-contacting components; no sterilization or shelf-life requirements. Compatibility tested with third-party 3D scanners, CAD/CAM machines, and vacuum forming equipment.

Indications for Use

Indicated for orthodontic patients requiring management of dental models, inspection, analysis, treatment simulation, and virtual appliance design before, during, and after orthodontic treatment.

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™ (K171634)

Reference Devices

• Orchestrate 3D (K181112)
• CEREC Ortho Software (K171122)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

July 21, 2020

Diorco Co., Ltd. % Edward Park CEO Radios LLC 4408 Tortuga Ln McKinney, Texas 75070

Re: K192847

Trade/Device Name: Autolign Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: June 16, 2020 Received: June 22, 2020

#### Dear Edward Park:

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

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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 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,

for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K192847

Device Name AUTOLIGN

#### Indications for Use (Describe)

The AUTOLIGN 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) 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 AUTOLIGN 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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### 510(k) Summary - Traditional 510(k)

## Submitter Information

| Company Name: | DIORCO Co., Ltd. |
|------------------------|-----------------------------------------------------------------------|
| Company Address: | 4F, 26, Yeongil-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16705, Korea |
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Person: | HWI JOON PARK, Official Correspondent for DIORCO Co., Ltd. |
| Date Summary Prepared: | Aug 30, 2019 |

## Device Identification

| Trade / Proprietary name: | AUTOLIGN |
|---------------------------|-----------------------------|
| 510(k) Number: | K192847 |
| Regulation Number: | 872.5470 |
| Regulation Name: | Orthodontic Plastic Bracket |
| Classification: | Class II |
| Product Code: | PNN, LLZ |

## Predicate Device

Primary predicate device: Ortho System™ (3Shape A/S) - K171634 Reference device: Orchestrate 3D (Orchestrate 3D) - K181112 Reference device: CEREC Ortho Software (Dentsply Sirona) - K171122

## Device Description

The AUTOLIGN is stand-alone software which utilizes images of the patient's intraoral anatomy from intraoral cameras and/or desktop laboratory scanners to create a 3D virtual dental model that can be used in the same manner as a traditional physical dental model. AUTOLIGN facilitates the segmentation and editing of the 3D virtual digital model as well as analysis which can be used in secondary orthodontic treatment planning. The software allows for measurement- including Bolton analyses. The models and analysis produced by the proposed Software can be exported to an orthodontic laboratory or directly to orthodontic

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appliance manufacturers for use in orthodontic treatment planning and design of orthodontic appliances. The material used for vacuum pressing (thermoforming) the final device appliances of sequential aligners on the production cast is DURAN®, but those which satisfy all the requirements specified on the Autoling User Manual can also be used.

## Indications for Use

The AUTOLIGN 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) 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 AUTOLIGN 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 of Indication for Use Statements

The following table compares Indications for Use Statements between the Autolign and the three predicate devices, i.e. Ortho System™, Orchestrate 3D Orthodontic Software, and CEREC Ortho Software. Similar to the other predicate devices, the Autolign is used for managing patient and case base data, collection, alignment, measurement and analysis of study material, treatment of simulation, and virtual appliance design.

| AUTOLIGN | Ortho System™ | Orchestrate 3D<br>Orthodontic Software | CEREC Ortho<br>Software |
|--------------------------|--------------------------|-----------------------------------------------|--------------------------|
| The AUTOLIGN is | Ortho System™ is | The Orchestrate 3D<br>Orthodontic Software is | CEREC Ortho Software |
| intended for use as a | intended for use as a | indicated for use as a | is intended for use with |
| medical front-end device | medical front-end device | front-end software tool | image data acquired |
| providing tools for | providing tools for | for management of | from handheld intra oral |
| management of | management of | orthodontic models, | 3D cameras and desktop |
| orthodontic models, | orthodontic models, | systematic inspection, | laboratory scanners to |
| systematic inspection, | systematic inspection, | detailed analysis, | create 3D virtual models |
| detailed analysis, | detailed analysis, | treatment simulation and | to be used for data |
| treatment simulation and | treatment simulation and | virtual appliance design | acquisition and modeling |
| virtual appliance design | virtual appliance design | options, including dental | analysis for orthodontic |
| options (Export of | options (Custom Metal | casts, which may be | patients and conditions. |
| Models, Indirect | Bands, Export of | used for sequential | The CEREC Ortho |
| Bonding Transfer | Models, Indirect | aligner trays or retainers. | Software 3D model data |
| Media) based on 3D | Bonding Transfer | | can be exported to |

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| models of the patient's | Media) based on 3D | These applications are | orthodontic design |
|----------------------------|----------------------------|---------------------------|------------------------|
| dentition before the start | models of the patient's | based on 3D models of | software to aid in the |
| of an orthodontic | dentition before the start | the patient's dentition | design of orthodontic |
| treatment. It can also be | of an orthodontic | before the start of an | appliances. |
| applied during the | treatment. It can also be | orthodontic treatment. It | |
| treatment to inspect and | applied during the | can also be applied | |
| analyze the progress of | treatment to inspect and | during the treatment to | |
| the treatment. It can be | analyze the progress of | inspect and analyze the | |
| used at the end of the | the treatment. It can be | progress of the | |
| treatment to evaluate if | used at the end of the | treatment. It can be used | |
| the outcome is consistent | treatment to evaluate if | at the end of the | |
| with the planned/desired | the outcome is consistent | treatment to evaluate if | |
| treatment objectives. | with the planned/desired | the outcome is consistent | |
| The use of the | treatment objectives. | with the planned/desired | |
| AUTOLIGN requires the | The use of the Ortho | treatment objectives.se | |
| user to have the | System™ requires the | of the Orchestrate 3D | |
| necessary training and | user to have the | requires the user to have | |
| domain knowledge in | necessary training and | the necessary training | |
| the practice of | domain knowledge in | and domain knowledge | |
| orthodontics, as well as | the practice of | in the practice of | |
| to have received a | orthodontics, as well as | orthodontics, as well as | |
| dedicated training in the | to have received a | to have received a | |
| use of the software. | dedicated training in the | dedicated training in the | |
| | use of the software. | use of the software. | |

# Comparison of Technological Characteristics

Both AUTOLIGN and 3Shape Ortho System™ Software (K171634) are stand-alone software module. They also import digital patient scan files. All the digital data format used for AUTOLIGN are those which the predicate device is already supporting. Like the other predicate devices, AUTOLIGN can be used to design dental cast.With respect to the AUTOLIGN, the 3D virtual model and finalized analysis can be exported to support orthodontic diagnosis and treatment planning of tooth movement. It supports STL files.

| Comparison Item | AUTOLIGN | Ortho System™ | Orchestrate 3D<br>Orthodontic<br>Software | CEREC Ortho<br>Software |
|----------------------------------------------------------------|----------|---------------|-------------------------------------------|-------------------------|
| Stand-alone software<br>module | O | O | O | O |
| Imports scanned image<br>of patient | O | O | O | O |
| Can be used to design<br>dental casts | O | O | O | O |
| Useful for diagnosis,<br>treatment planning, and<br>CAD design | O | O | O | O |

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| Comparison Item | AUTOLIGN | Ortho System™ | Orchestrate 3D<br>Orthodontic<br>Software | CEREC Ortho<br>Software | | |
|---------------------------------------------------------|--------------------------------------|----------------------|-------------------------------------------|------------------------------------------|--|--|
| Virtual planning of tooth<br>movement | O | O | O | Unknown | | |
| Supports .stl files | O | O | O | O | | |
| Managing patient and case base data | | | | | | |
| Creating, editing, deleting<br>and copying patient data | O | O | O | O | | |
| Creating, editing, deleting<br>and copying case data | O | O | O | O | | |
| Collection of study material | | | | | | |
| Surface scan for intra-oral<br>scanner | X | O | O | O | | |
| Surface scan from STL<br>file | O | O | O | O | | |
| CT image data | X | O (DICOM) | X | X | | |
| 2D overlay | O (JPG, BMP) | O (PNG, JPG,<br>BMP) | X | X | | |
| Creation of virtual 3D<br>virtual dental models | O | O | O | O | | |
| Alignment of study material | | | | | | |
| Aligning surface scan or<br>CT image | O (but CT image<br>is not available) | O | X | O | | |
| Aligning cephalometric<br>images | O | O | X | O | | |
| Alignment of 2D overlays<br>(e.g. ideal arch) | O | O | X | O | | |
| Ability to check/adjust<br>DICOM visibility | X | O | X | O | | |
| DICOM scan<br>segmentation | X | X | X | O | | |
| Measuring study material | | | | | | |
| 2D measurement toolbox | O | O | X | O | | |
| 3D measurement toolbox | X | O | X | O | | |
| Analyzing study material | | | | | | |
| Definition of dental Arch<br>shape & length | O | O | O | O | | |
| Wire length | X | O | X | O | | |
| Tooth width<br>measurements | O | O | X | O | | |
| Comparison Item | AUTOLIGN | Ortho System™ | Orchestrate 3D<br>Orthodontic<br>Software | CEREC Ortho<br>Software | | |
| Tooth and gingiva<br>separation/segmentation | O | Unknown | Unknown | O | | |
| Bolton's analysis | O | O | X | O | | |
| Space analysis | O | O | X | O (Nance and<br>Moyer space<br>analysis) | | |
| Overjet/overbite | X | O | O | Unknown | | |
| Occlusal mapping | O | O | O | O | | |
| Treatment simulation | | | | | | |
| 2D simulation | X | O | X | X | | |
| 3D simulation | O | O | O | X | | |
| Virtual appliance design | | | | | | |
| Orthodontic appliance<br>search | O | O | X | X | | |
| Orthodontic appliance<br>virtual preparation | O | O | O | X | | |
| Orthodontic appliance<br>design | O | O | O | X | | |
| Orthodontic appliance<br>export | O | O | O | X | | |

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Most comparison items between the subject device and the primary predicate device are identical. However, the other items, which are not identical to the primary predicate device, such as CT image data availability, Ability to check/adjust DICOM visibility, 3D measurement toolbox, Wire length analyzing study material, and 2D treatment simulation, are identical to the other two reference devices.

#### Non-clinical Tests

The AUTOLIGN underwent software, hardware, integration, verification and validation testing in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005). The software passed the testing and performed per its intended use.

The AUTOLIGN does not include any physical device, accessory, or component with patient contacting intended use. Therefore, no sterilization, or shelf life analyses were included in support of substantial equivalence. However, we tested the compatibility of accessories from other manufacturers such as 3D scanners, CAD/CAM production machines, dental vacuum forming machines, and dental cast material sheets to mitigate concerns with biocompatibility of the proposed device.

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## Conclusion

Based on comparison of indications for use, scientific concept, technological features, technical data, performance testing, and software validation testing, the AUTOLIGN is found to be as safe and as effective as the primary predicate device. And All the results have been reviewed and approved, showing the AUTOLIGN to be substantially equivalent to the primary predicate device.