DIBS (Digital Indirect Bonding System)

K192701 · Orthoselect, LLC · PNN · Apr 21, 2020 · Dental

Device Facts

• Record ID: K192701
• Device Name: DIBS (Digital Indirect Bonding System)
• Applicant: Orthoselect, LLC
• Product Code: PNN · Dental
• Decision Date: Apr 21, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5470
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

DIBS by OrthoSelect 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 DIBS by OrthoSelect 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

DIBS is a standalone software system for managing 3D scanned orthodontic models. Input: 3D dental scans (STL files). Operation: software tools enable virtual orthodontic treatment planning, tooth movement simulation, virtual bracket placement, and appliance design. Output: STL files for manufacturing Indirect Bonding Transfer Trays. Used in clinical settings by orthodontists; requires specialized training. Healthcare providers use the software to visualize, measure, and analyze dentition; output facilitates precise bracket placement and treatment planning, potentially improving orthodontic treatment accuracy and efficiency.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation performed per FDA software guidance and IEC 62304 standards.

Technological Characteristics

Standalone software; Windows-based (7/8 64-bit); requires minimum 4GB RAM, 1GB video memory, 250GB HDD. No patient contact. No hardware components. Connectivity via network/internet.

Indications for Use

Indicated for orthodontic patients requiring management of 3D dental models, treatment simulation, and virtual appliance design. 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

• 3Shape Ortho System (K152086)

Submission Summary (Full Text)

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April 21, 2020

OrthoSelect, LLC % Carmine Jabri President E.M.M.A International Consulting Group Inc. 27600 Farmington Road, Suite 100 Farmington Hills, Michigan 48334

Re: K192701

Trade/Device Name: DIBS (Digital Indirect Bonding System) Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: March 20, 2020 Received: March 23, 2020

Dear Carmine Jabri:

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.

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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 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-reporting-

combination-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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K192701

#### Device Name

DIBS (Digital Indirect Bonding System)

#### Indications for Use (Describe)

DIBS by OrthoSelect 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 DIBS by OrthoSelect 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)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Number (K192701) 510(k) SUMMARY - Traditional 510(k)

A summary of information in accordance with requirements of 21 CFR 807.92.

## SUBMITTER'S INFORMATION

| Sponsor: | OrthoSelect, LLC |
|-------------------------|------------------------------------------------------------------------------------------------------------------------|
| Address: | 831 E 340 S Suite 170<br>American Fork, UT 84003, USA |
| Official Correspondent: | Carmine Jabri<br>E.M.M.A International Consulting Group Inc.<br>+1 248.987.4497<br>[e-mail] |
| Date Summary Prepared: | April 20, 2020 |

## DEVICE INFORMATION

| Name of Device: | DIBS (Digital Indirect Bonding System) |
|----------------------------|-----------------------------------------------|
| Common Name: | Orthodontic Software |
| Classification Name: | 21 CFR 872.5470 – Orthodontic plastic bracket |
| Product Code: | PNN |
| Secondary Product<br>Code: | LLZ |
| Device Classification: | Class II |

# PREDICATE DEVICE

K152086 - 3Shape A/S - 3Shape Ortho System Primary Predicate Device:

# DEVICE DESCRIPTION

DIBS by OrthoSelect is a software system used for the management of 3D scanned orthodontic models of the patients' dentition and allows orthodontic measurements, analysis, inspection, and visualization. The primary purpose of DIBS is to allow virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets, and design of orthodontic appliances based on the 3D scanned orthodontic models. Output includes STL files that can be used to make Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays).

· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com Page 1 of 6

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The device has no patient contact. DIBS is a software-only device with the following hardware requirements:

| Item | Minimum Requirements |
|---------------------|-----------------------------------|
| OS | Windows 7 or 8 64-bit |
| RAM | 4 GB or more |
| Monitor Resolution | 1280x800 or similar |
| Video Card Memory | 1 GB GeForce |
| Available HDD Space | 250 GB |
| CPU | IntelCore i3 or higher equivalent |
| Network | Network Internet Connection |
| Mouse | With scroll wheel recommended |

· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com

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#### INDICATIONS FOR USE

DIBS by OrthoSelect 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 DIBS by OrthoSelect 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 TO PREDICATE DEVICE

DIBS has the same intended uses and is subject to the same regulation as the Ortho System from 3Shape A/S (K152086):

| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SPONSOR | OrthoSelect | 3Shape |
| TRADE NAME | DIBS | Ortho System |
| 510(k) NUMBER | --- | K152086 |
| PRODUCT CODE | PNN | PNN |
| Secondary Product Code | LLZ | LLZ |
| INDICATIONS FOR USE | DIBS by OrthoSelect is<br>intended for use as a medical<br>front-end device providing tools<br>for management of orthodontic<br>models, systematic inspection,<br>detailed analysis, treatment<br>simulation and virtual appliance<br>design options (Export of<br>Models, Indirect Bonding<br>Transfer Media) based on 3D<br>models of the patient's dentition<br>before the start of an<br>orthodontic treatment. It can | 3Shape Ortho System is<br>intended for use as a medical<br>front-end device providing tools<br>for management of orthodontic<br>models, systematic inspection,<br>detailed analysis, treatment<br>simulation and virtual appliance<br>design options (Custom Metal<br>Bands, Export of Models,<br>Indirect Bonding Transfer<br>Media) based on 3D models of<br>the patient's dentition before<br>the start of an orthodontic |

· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com Page 3 of 6

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#### E.M.M.A. International Consulting Group, Inc.

| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SPONSOR | OrthoSelect | 3Shape |
| TRADE NAME | DIBS | Ortho System |
| 510(k) NUMBER | --- | K152086 |
| | also be applied during the<br>treatment to inspect and<br>analyze the progress of the<br>treatment. It can be used at the<br>end of the treatment to evaluate<br>if the outcome is consistent with<br>the planned/desired treatment<br>objectives. | treatment. It can also be<br>applied during the treatment to<br>inspect and analyze the<br>progress of the treatment. It can<br>be used at the end of the<br>treatment to evaluate if the<br>outcome is consistent with the<br>planned/desired treatment<br>objectives. |
| | The use of the DIBS by<br>OrthoSelect requires the user to<br>have the necessary training and<br>domain knowledge in the<br>practice of orthodontics, as well<br>as to have received a dedicated<br>training in the use of the<br>software. | The use of the Ortho System<br>requires the user to have the<br>necessary training and domain<br>knowledge in the practice of<br>orthodontics, as well as to have<br>received a dedicated training in<br>the use of the software. |
| GENERAL DESCRIPTION | Stand Alone Software | Stand Alone Software |
| SUPPORTED ANATOMIC<br>AREAS | Maxilla, Mandible | Maxilla, Mandible |
| PATIENT CONTACT | None | None |

Additionally, DIBS has many of the same features that the predicate device, Ortho System from 3Shape A/S (K152086), has:

| FEATURE | SUBJECT DEVICE | PREDICATE DEVICE |
|----------------------------------------------------------|------------------|---------------------|
| | OrthoSelect DIBS | 3Shape Ortho System |
| 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 |
| Managing patient and case base data | | |
| Creating, editing, deleting, and copying<br>patient data | Yes | Yes |

· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com Page 4 of 6

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| Creating, editing, deleting, and copying case data | Yes | Yes |
|----------------------------------------------------|-----|---------------|
| Collection of study material | Yes | Yes |
| Surface scan for intra-oral scanner | Yes | Yes |
| Surface scan from STL file | Yes | Yes |
| CT image data | No | DICOM |
| 2D overlay | No | PNG, JPG, BMP |
| Alignment of study material | | |
| Aligning surface scan and CT image | No | Yes |
| Aligning cephalometric images | No | Yes |
| Alignment of 2D overlays (e.g., ideal arch) | Yes | Yes |
| Ability to check/adjust DICOM visibility | No | Yes |
| DICOM scan segmentation | No | No |
| Measuring study material | | |
| 2D measurement toolbox | Yes | Yes |
| 3D measurement toolbox | Yes | Yes |
| Analyzing study material | | |
| Arch shape | Yes | Yes |
| Wire length | Yes | Yes |
| Tooth width | Yes | Yes |
| Bolton | Yes | Yes |
| Space analysis | Yes | Yes |
| Overjet/overbite | Yes | Yes |
| Occlusion map | Yes | Yes |
| Treatment simulation | | |
| 2D & 3D simulation | Yes | Yes |
| Virtual appliance design | Yes | Yes |
| Orthodontic appliance search | Yes | Yes |
| Orthodontic appliance virtual preparation | Yes | Yes |
| Orthodontic appliance design | Yes | Yes |
| Orthodontic appliance export | Yes | Yes |

Differences between the features do not affect the safety or effectiveness of DIBS compared to its predicate device.

# PERFORMANCE DATA

Medical device 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 2005). Validation was performed in conformity with IEC 62304 - Medical device software - Software lifecycle processes.

· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com Page 5 of 6

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Documentation was also prepared in accordance to FDA quidance documents, "General Principles of Software Validation" (issued January 2002) and "Off-The-Shelf Software Use in Medical Devices" (issued September 1999).

### CONCLUSIONS

DIBS has the same intended use as the predicate device, Ortho System (K152086). Both devices are orthodontic software devices requlated under 21 CFR 872.5470 and are intended to aid in orthodontic treatment planning and allow the export of orthodontic appliance designs.

The predicate 3Shape Ortho System (K152086) is additionally regulated as a Radiological Image Processing System under 21 CFR 892.2050 due to its functionality to utilize CT DICOM images as input. DIBS does not have this functionality, however, this difference does not affect the safety or effectiveness of DIBS.

Based on the comparison between indications for use, technological features, performance testing, and software validation testing, DIBS has been shown to be substantially equivalent to the legally marketed device, Ortho System (K152086).

· Farmington Hills, MI · Clearwater, FL · York, PA · Grand Rapids, MI · Worldwide · 248-987-4497 / www.emmainternational.com Page 6 of 6