NemoCast

K232549 · Software Nemotec S.L. · PNN · Nov 21, 2023 · Dental

Device Facts

• Record ID: K232549
• Device Name: NemoCast
• Applicant: Software Nemotec S.L.
• Product Code: PNN · Dental
• Decision Date: Nov 21, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

NemoCast 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. It can also be applied during the treatment to inspect and analyze the progress of the treatment. The use of the NemoCast 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

NemoCast is a software system for orthodontic treatment planning and management. It processes 3D scanned dental models (from intra-oral scanners or STL/PLY/OBJ files) and DICOM CT image data. The software enables dental professionals to perform systematic inspection, 2D/3D measurements, and orthodontic analysis (e.g., arch shape, Bolton analysis, space analysis, overjet/overbite). It supports virtual treatment simulation, tooth movement planning, and virtual placement of orthodontic brackets. The device produces STL files for dental casts or aligner printing and designs for Indirect Bonding Transfer Trays. Used in clinical settings by trained dental professionals, the software assists in visualizing treatment progress and evaluating outcomes against planned objectives. It does not have patient contact.

Clinical Evidence

No clinical data. Bench testing only. The device underwent design verification and validation testing in accordance with a documented test plan. Performance testing was leveraged from the reference device (K193003).

Technological Characteristics

Software-based orthodontic planning tool; C++ language; Windows OS; supports STL, PLY, OBJ, and DICOM formats; provides 2D/3D measurement, segmentation, and virtual appliance design; standalone software application.

Indications for Use

Indicated for patients requiring orthodontic treatment. Used by dental professionals for management of orthodontic models, inspection, measurement, analysis, treatment simulation, and virtual appliance design.

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

• NemoCast (K193003)

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

November 21, 2023

Software Nemotec S.L. % Kevin Walls Principal Consultant Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127

Re: K232549

Trade/Device Name: NemoCast Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: August 23, 2023 Received: August 23, 2023

Dear Kevin Walls:

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.

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"

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

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Sincerely,

# Michael E. 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) K232549

Device Name

NemoCast

Indications for Use (Describe)

NemoCast 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 treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned dectives. It can also be applied during the treatment to inspect and analyze the progress of the treatment.

The use of the NemoCast 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

즈 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the letters in a dark blue color. Below the word "NEMOTEC" is the phrase "A BIOTECH DENTAL COMPANY" in a smaller, lighter blue font. To the right of the text is a circular graphic with a dark blue circle in the center and three light blue segments around it.

## 510(K) Summary - K232549

This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## Applicant Information:

Software Nemotec S.L.

Av. Juan Caramuel, №1

Leganés, Madrid, Spain, 28919

### Submission Correspondent:

Kevin Walls Principal Consultant, Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton, Colorado 80127

#### Device Information:

| Trade Name: | NemoCast |
|----------------------------|-----------------------------|
| Common Name: | Orthodontic Software |
| Classification Name: | Orthodontic Plastic Bracket |
| Classification Regulation: | 21CFR 872.5470 |
| Device Class: | II |
| Product Code: | PNN, LLZ |

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Image /page/5/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the "NEMO" in a darker blue and the "TEC" in a lighter blue. Below the name is the text "A BIOTECH DENTAL COMPANY" in a smaller, lighter font. To the right of the name is a circular graphic divided into three sections of varying shades of blue, with a dark blue circle in the center.

#### Reference Device:

NemoCast, Software Nemotec, K193003

#### Primary Predicate:

3Shape Ortho System™, 3Shape A/S, K152086

#### Date Prepared:

Aug 08, 2023

#### Predicate Device:

The NemoCast Software has the same intended uses and technical characteristics as primary predicate 3Shape Ortho System™ (K152086) from 3Shape A/S and reference predicate NemoCast from Software Nemotec (K193003) as listed in the table below:

Based on the information and supporting documentation provided, the NemoCast Software and the primary predicate (3Shape Ortho System™) have the same intended use.

Both software devices are used by Dental Professionals in orthodontic treatment planning (before, during, after treatment) covering management of patients and models, inspection, 2D and 3D measurement and orthodontic analysis of models, 2D & 3D treatment simulation, as well as virtual appliance preparation, handling and export, and they are both providing device output. Additionally, the indirect bonding functionality of both systems is intended for use with commercially available brackets and wires. Therefore, the NemoCast Software and the primary predicate (3Shape) are found to be similar in their intended use, supported anatomic areas and the majority of the available features and functionalities.

#### Device Description:

NemoCast 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, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes STL Models (also called dental casts) for thermoforming aligners, STL files for direct printing aligners and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). The device has no patient contact.

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Image /page/6/Picture/0 description: The image is a logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in a sans-serif font, with the first three letters in a darker blue and the last four letters in a lighter blue. Below the word "NEMOTEC" is the phrase "A BIOTECH DENTAL COMPANY" in a smaller, sans-serif font. To the right of the word "NEMOTEC" is a circular graphic divided into three sections, with a smaller circle in the center.

### Indications for Use:

NemoCast 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. It can also be applied during the treatment to inspect and analyze the progress of the treatment.

The use of the NemoCast 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.

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Image /page/7/Picture/0 description: The image shows the logo for NEMOTEC, a biotech dental company. The word "NEMOTEC" is written in large, bold, dark blue letters. Below the word "NEMOTEC" is the phrase "A BIOTECH DENTAL COMPANY" in smaller, light blue letters. To the right of the text is a circular graphic with three sections in different shades of blue and a dark blue circle in the center.

# Comparison of Intended Use and Technological Characteristics with the reference Device:

| Substantial Equivalence Table | | | | |
|-----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature name | SUBJECT<br>DEVICE<br>NemoCast | REFERENCE<br>DEVICE<br>NemoCast<br>(K193003) | PRIMARY<br>PREDICATE<br>3Shape Ortho<br>System ™,<br>K152086 | Differences |
| Product Code | PNN, LLZ | PNN, LLZ | PNN, LLZ | None |
| Common Name | Orthodontic<br>Software | Orthodontic<br>Software | Orthodontic<br>Software | None |
| Classification Name | Orthodontic<br>Plastic<br>Bracket | Orthodontic<br>Plastic Bracket | Orthodontic<br>Plastic Bracket | None |
| Regulation Number | 21 CFR<br>872.5470 | 21 CFR<br>872.5470 | 21 CFR<br>872.5470 | None |
| Supported anatomic areas | Maxilla and<br>Mandible | Maxilla and<br>Mandible | Maxilla and<br>Mandible | None |
| Intended Use | | | | |
| Use by dental professionals in<br>orthodontic treatment<br>planning (before, during, after<br>treatment). | Yes | Yes | Yes | Reference device<br>NemoCast was<br>used by dental<br>professionals<br>only before<br>treatment. |
| Management of patients and<br>models. | Yes | Yes | Yes | None |
| Inspection, measurement and<br>analysis of orthodontic<br>models. | Yes | Yes | Yes | None |
| Treatment simulation. | Yes | Yes | Yes | None |
| Virtual appliance preparation<br>(including dental casts),<br>handling and export. | Yes | Yes | Yes | None |
| Provide digital file and device<br>output. | Yes | Yes | Yes | All 3 devices<br>output STL files<br>for fabrication of<br>dental casts.<br>The subject<br>Device and<br>predicate Device |
| | | | | both additionally<br>output indirect<br>Bonding Transfer<br>Media. |
| Supported PC formats | Windows | Windows | Windows | None |
| Managing patient and case base data: | | | | |
| Creating, editing, deleting<br>and copying patient data | Yes | Yes | Yes | None |
| Creating, editing, deleting<br>and copying case data | Yes | Yes | Yes | None |
| Collection of study material | | | | |
| Surface scan from<br>intra-oral scanner | Yes | Yes | Yes | None |
| Surface scan from STL, PLY,<br>OBJ file | Yes | No | Yes, only STL | Although<br>predicate device<br>only import STL<br>format, the OBJ<br>and PLY formats<br>are other<br>equivalent<br>formats which do<br>not affect the<br>security and<br>safety of the<br>device. |
| CT image data | DICOM | DICOM | DICOM | None |
| 2D overlay | PNG, JPG,<br>BMP | PNG, JPG,<br>BMP | PNG, JPG,<br>BMP | None |
| Alignment of study material | | | | |
| Aligning surface scan and<br>CT image | Yes | Yes | Yes | None |
| Aligning cephalometric<br>images | Yes | Yes | Yes | None |
| Alignment of surface scan<br>with 2D overlays | Yes | Yes | Yes | None |
| Ability to check/adjust<br>DICOM visibility | Yes | Yes | Yes | None |
| DICOM scan segmentation | Yes | Yes | Yes | None |
| Occlusal Orientation | Yes | Yes | No | Although the<br>predicate device<br>does not perform<br>occlusal |
| | | | | orientation, the |
| | | | | reference device |
| | | | | contains this |
| Segmenting teeth roots | Yes | Yes | No | option.<br>Although the |
| | | | | predicate device |
| | | | | does not |
| | | | | segment teeth |
| | | | | roots, the |
| | | | | reference device |
| | | | | contains this |
| | | | | option. |
| DICOM orientation | Yes | Yes | Yes | None |
| Measuring study material | | | | |
| 2D measurement toolbox | Yes | Yes | Yes | None |
| 3D measurement toolbox | Yes | Yes | Yes | None |
| Analyzing study material | | | | |
| Arch shape | Yes | Yes | Yes | None |
| Wire length | Yes | Yes | Yes | None |
| Tooth width | Yes | Yes | Yes | None |
| Bolton | Yes | No | Yes…