3Shape Splint Design

K191911 · 3Shape A/S · PNN · Nov 27, 2019 · Dental

Device Facts

• Record ID: K191911
• Device Name: 3Shape Splint Design
• Applicant: 3Shape A/S
• Product Code: PNN · Dental
• Decision Date: Nov 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

3Shape Splint Design for splints and mouthguards is intended for use as a medical front-end device providing tools for systematic inspection, detailed analysis, treatment simulation and virtual appliance design based of 3D models of the patient's dentition before the start of an orthodontic treatment. The use of Splint Design software 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

3Shape Splint Design is a software-only medical device used by dental professionals for virtual orthodontic treatment planning. It accepts 3D scanned dental models (STL, DCM formats) as input. The software provides tools for systematic inspection, occlusion mapping, virtual articulation, and CAD design of customized splints and mouthguards. It operates on standard Windows-based PCs. The output is a digital design file exported for production via 3D printing or milling using FDA-cleared materials. The device does not have patient contact. It assists clinicians in visualizing jaw movements and designing appliances, which are then manufactured under the user's control. The software facilitates precise appliance fabrication, potentially improving treatment outcomes and patient comfort.

Clinical Evidence

No clinical data was performed. Substantial equivalence is supported by software, hardware, and integration verification and validation testing conducted in accordance with FDA guidance.

Technological Characteristics

Software-only device programmed in C# and Delphi. Operates on Windows 7, 8, or 10 (64-bit). Minimum hardware: Intel Core i5, 8 GB RAM, 1 GB video memory, 250 GB HDD. Connectivity via network/internet. Inputs: 3D surface scans (STL, DCM). Outputs: CAD design files for 3D printing/milling. No patient contact.

Indications for Use

Indicated for use by trained orthodontic professionals for inspection, analysis, treatment simulation, and virtual design of splints and mouthguards/nightguards based on 3D dental models prior to 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

• 3Shape Ortho System™ - Splint (K161884)

Submission Summary (Full Text)

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November 27, 2019

3Shape A/S Shreyosi Chakraborty Regulatory Affairs Specialist Holmens Kanal 7 DK-1060 Copenhagen K

Re: K191911

Trade/Device Name: 3Shape Splint Design Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: PNN Dated: September 10, 2019 Received: September 13, 2019

Dear Shreyosi Chakraborty:

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,

for Srinivas Nandkumar, Ph.D. Acting 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) K191911

Device Name 3Shape Splint Design

#### Indications for Use (Describe)

3Shape Splint Design for splints and mouthguards is intended for use as a medical front-end device providing tools for systematic inspection, detailed analysis, treatment simulation and virtual appliance design based of 3D models of the patient's dentition before the start of an orthodontic treatment.

The use of Splint Design software 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)

| <span style="font-family: sans-serif;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|----------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: sans-serif;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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### 510(K) SUMMARY K191911

#### Submitter Information

| Company Name: | 3Shape A/S |
|------------------------|-------------------------------------------------------|
| Company Address: | Holmens Kanal 7<br>DK-1060 Copenhagen K |
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Person: | Shreyosi Chakraborty<br>Regulatory Affairs Specialist |
| Date Summary Prepared: | September 3, 2019 |

### Device Identification

| 510(k) number: | K191911 |
|-------------------------|----------------------------|
| Trade/proprietary Name: | 3Shape Splint Design |
| Regulation Number: | 872.5470 |
| Classification: | Class 2 |
| Product Code: | PNN (Orthodontic Software) |

### Primary Predicate Device

The Splint design software for splints and mouthguards (K191911), based on the information and supporting documentation provided, and has the same intended use, scientific concept and technical characteristics as the primary predicate device 3Shape Ortho System™ - Splint (K161884) also manufactured by 3Shape A/S.

Both software devices are used by Dental Professionals in orthodontic treatment planning (before, during, after treatment) covering inspection, 2D measurement and analysis of orthodontic appliances, treatment simulation with virtual articulation, as well as virtual appliance design, handling and export, and they are both providing CAM output for 3D printers and milling machines.

Specifically, the functionality included in the new, the proposed device to realize splints and mouthguards using of digital design manufactured by approved materials are identical for the two devices. Therefore, the Splint Design software (K191911) and the predicate (K161884) are found to be similar in their intended use, supported anatomic areas and the available relevant features and functionalities.

#### Indications for Use

3Shape Splint Design for splints and mouthquards/nightquards is intended for use as a medical front-end device providing tools for systematic inspection, detailed

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analysis, treatment simulation and virtual appliance design based on 3D models of the patient's dentition before the start of an orthodontic treatment.

The use of Splint Design software 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 Description

The Splint design software for splints and mouthquards/nightquards is a software system used for the virtual planning of orthodontic treatments by simulating jaw movements, and design of orthodontic appliances based on 3D scanned orthodontic models.

The realization of the above-mentioned orthodontic appliances is done using splint workflow which supports

- Direct production using 3D printer or milling machines with FDA cleared or . listed materials included in the splint workflow.
The actual production of appliances is done by the user and it is under their control and responsibility.

3Shape Splint Design has no patient contact being a software only device.

#### Scientific Concept

The underlying scientific concept of the Splint Design software is to apply digital imaging tools for orthodontic treatment planning and CAD design of customized appliances.

The system supports the following types of digital data: dcm and STL

#### Summary of the technological characteristics

Ortho System™ is a software only device programmed in C# and Delphi and has the following PC/laptop hardware requirements equivalent to the reference devices:

| Item | Minimum Requirements<br>Splint Design<br>(K19XXXX) | Minimum Requirements<br>3Shape Ortho System™<br>(K161884) |
|-------------------------|----------------------------------------------------|-----------------------------------------------------------|
| OS: | Windows 7, 8 or 10 64-bit | Windows 7 or 8, 64-bit |
| RAM: | 8 GB | 8 GB |
| Monitor<br>Resolution: | 1280x800 or similar | 1280x800 or similar |
| Video Card<br>Memory: | 1 GB | 1 GB |
| Available<br>HDD Space: | 250 GB | 250 GB |
| CPU: | Intel Core i5 or equivalent | Intel Core i5 or equivalent |
| Network: | Network Internet connection | Network Internet connection |

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| Mouse: | With wheel button | With wheel button |
|--------|-------------------|-------------------|
|--------|-------------------|-------------------|

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The Splint Design software has the same intended uses and technical characteristics as the Ortho System™ software (K161884) also manufactured by 3Shape A/S:

| Feature ID & Name | Splint<br>Design<br>K191911 | Ortho<br>System™<br>K161884 | Applicable for Splint<br>and<br>Mouthguard/Nightgua<br>rd Treatment<br>Simulation |
|-------------------------------------------------------------|-----------------------------|-----------------------------|-----------------------------------------------------------------------------------|
| Supported anatomic areas | Maxilla<br>Mandible | Maxilla<br>Mandible | Yes<br>Yes |
| Intended use | | | |
| 1. Managing patient and case base<br>data | No | Yes | No |
| 2. Collection of study material | Yes | Yes | Yes |
| 3. Alignment of study material | No | Yes | No |
| 4. Measuring study material | Yes | Yes | Yes |
| 5. Analyzing study material | Yes | Yes | Yes |
| 6. Treatment simulation | Yes | Yes | Yes |
| 7. Virtual appliance design | Yes | Yes | Yes |
| 8. Supported PC formats | Windows | Windows | |
| Managing patient and case base data | | | |
| 1.1 Creating, editing, deleting and<br>copying patient data | No | Yes | No |
| 1.2 Creating, editing, deleting and<br>copying case data | No | Yes | No |
| Collection of study material | | | |
| 2.1 Surface scan for intra-oral<br>scanner | Yes | Yes | Yes |
| 2.2 Surface scan from STL file | Yes | Yes | Yes |
| 2.3 CT image data | No | DICOM | No |
| 2.4 2D overlay | No (PNG, JPG,<br>BMP) | PNG, JPG,<br>BMP | No |
| Alignment of study material | | | |
| 3.1 Aligning surface scan and CT<br>image | No | Yes | No |
| 3.2 Aligning cephalometric images | No | Yes | No |
| 3.3 Alignment of 2D overlays (e.g.<br>ideal arch) | No | Yes | No |
| 3.4 Ability to check/adjust DICOM<br>visibility | No | Yes | No |
| 3.5 DICOM scan segmentation | No | No | No |
| Measuring study material | | | |
| 4.1 2D measurement toolbox | Yes | Yes | Yes |
| 4.2 3D measurement toolbox | No | Yes | No |
| Analyzing study material | | | |
| 5.1 Arch shape | No | Yes | No |
| 5.2 Wire length | No | Yes | No |
| 5.3 Tooth width | No | Yes | No |
| 5.4 Bolton | No | Yes | No |
| 5.5 Space analysis | No | Yes | No |
| 5.6 Overjet/overbite | No | Yes | No |
| 5.7 Occlusion map | Yes | Yes | Yes |
| Treatment simulation | | | |
| 6.1 2D & 3D simulation | No | Yes | No |
| 6.2 Virtual articulator | Yes | Yes | Yes |
| Virtual appliance design | | | |
| 7.1 Orthodontic appliance search | No | Yes | No |
| 7.2 Orthodontic appliance virtual<br>preparation | No | Yes | No |
| 7.3 Orthodontic appliance design | Yes | Yes | Yes |
| 7.4 Orthodontic appliance export | Yes | Yes | Yes |

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## 3SHAPE SPLINT DESIGN SOFTWARE - 510(K) SUBMISSION

# ssha

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# ssha

### Nonclinical Testing

Software, hardware, and integration 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 on May 11, 2005).

The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.

All test results have been reviewed and approved, showing the Ortho System™ to be substantially equivalent to the primary predicate device.

#### Clinical Testing

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

#### Conclusion

Based on a comparison of intended use, indications, principle of operations, features and technical data, and the test results, the Splint Design software for splints and mouthguards/nightguards is found to be as safe and as effective as the primary predicate device. Therefore, intended use and performance are found to be substantially equivalent to those of the primary predicate device.