ITERO SOFTWARE

K131101 · Cadent, Ltd. an Align Technology Company · NHA · Aug 26, 2013 · Dental

Device Facts

• Record ID: K131101
• Device Name: ITERO SOFTWARE
• Applicant: Cadent, Ltd. an Align Technology Company
• Product Code: NHA · Dental
• Decision Date: Aug 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. iTero software controls the processing of the data, facilitating the integration of data, and exporting of the data for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories. In addition to scan data, various patient and case information can be imported/exported or used for simulation purposes. Other functions are available for verification and service of the system and to serve as an order management tool.

Device Story

iTero software operates with iTero scanner to capture 3D digital impressions of teeth, oral soft tissue, and bite relationships; software processes, integrates, and exports scan data via secure internet connection for CAD/CAM fabrication of dental restorations, orthodontic devices, and abutments. Used by dental professionals in clinical settings; software enables patient/case information management, simulation, and system verification. Output facilitates clinical decision-making by providing accurate digital models for restorative and orthodontic planning; benefits include improved workflow efficiency and digital integration for dental manufacturing.

Clinical Evidence

Bench testing only. Verification and validation testing demonstrated conformity with pre-established specifications and acceptance criteria to ensure safety and effectiveness.

Technological Characteristics

Software-based system running on Windows OS; developed in C++ and C#. Supports STL data format for import/export. Features 2D and 3D data visualization. Functions include patient data entry, scanning, data review/editing, data transfer, and order management. Connectivity via secure internet for data export.

Indications for Use

Indicated for dental professionals to capture 3D digital impressions of teeth, oral soft tissue, and bite relationships for the fabrication of dental restorations, orthodontic devices, abutments, and accessories.

Regulatory Classification

Identification

An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

Predicate Devices

• 3M Lava Software (K062493)
• Straumann Visual Software (K093113)

Submission Summary (Full Text)

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# SECTION 5: 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: July 26, 2013

510(k) number: K131101

#### Applicant Information:

Cadent, Ltd. An Align Technology Company 2560 Orchard Parkway San Jose, CA 95131

AUG 2 6 2013

## Contact Person

Manas M Lele Regulatory Affairs Analyst Alian Technology, Inc. Phone: [phone] Fax: [phone] Email: [e-mail]

#### Device Information:

Trade Name: Classification: Classification Name: iTero Software 21 CFR 872.3630 Abutment, Implant, Dental, Endosseous

## Description:

The iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. The software supports dental professionals in acquiring very accurate digital images which can be edited and used for planning and simulation. The software controls the export of the data by a secured internet connection for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories.

#### Intended Use:

iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. iTero software controls the processing of the data, facilitating the integration of data, and exporting of the data for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories. In addition to scan data, various patient and case information can be imported/exported or used for simulation purposes. Other functions are available for verification and service of the system and to serve as an order management tool.

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# Equivalent Device:

iTero Software is substantially equivalent in intended use and/or method of operation to the following devices:

| Name | Manufacturer | 510(k) # |
|---------------------------|-------------------------------|----------|
| 3M Lava Software | Brontes Technologies, Inc./3M | K062493 |
| Straumann Visual Software | Institut Straumann, AG | K093113 |

## Summary of Technical Characteristics:

| Characteristic | Cadent iTero Software | 3M Lava Software | Straumann Software |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use statement | iTero software is used<br>with the iTero scanner<br>in capturing 3D digital<br>impressions of teeth,<br>oral soft tissue and<br>structures, and bite<br>relationship. The<br>software controls the<br>processing of the data,<br>facilitating the<br>integration of data, and<br>exporting of the data for<br>CAD/CAM fabrication of<br>dental restorations,<br>orthodontic devices,<br>abutments, and<br>accessories. In addition<br>to scan data, various<br>patient and case<br>information can be<br>imported/exported or<br>used for simulation<br>purposes. Other<br>functions are available<br>for verification and<br>service of the system<br>and to serve as an order<br>management tool. | The Lava software is<br>used with the Lava<br>scanner, an all-ceramic<br>system for the<br>CAD/CAM fabrication of<br>dental restorations,<br>abutments, orthodontic<br>devices, and<br>accessories. The<br>software controls the<br>measuring process,<br>processing of the<br>measurement data (3D-<br>CAD tool), and export of<br>the data to the milling<br>machine. In addition,<br>various patient and case<br>information elements<br>can be entered. Other<br>functions are available<br>for verification and<br>service of the<br>measuring system. The<br>Lava software also<br>facilitates the transfer of<br>3D data from a scanner<br>to a remote milling<br>machine via internet. | Straumann<br>etkon visual is a<br>software device<br>intended to import<br>patient-specific data<br>from a scanner for<br>CAD (computer aided<br>design) design of<br>individual dental<br>restorations like<br>crowns, bridges,<br>inlays, onlays,<br>veneers, and<br>abutments. The visual<br>software also<br>facilitates the transfer<br>of 3D data from a<br>dental lab to a remote<br>milling center by<br>internet connection<br>and serves as an<br>order management<br>tool. |
| Operating System | Windows | Linux | Windows |
| Programming Language | C++ and C# | C++ | C++ and Java |
| Import/Export Data<br>Format | STL | STL | STL |
| Data Visualization | 2D and 3D | 2D and 3D | 3D |

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| Characteristic | Cadent iTero Software | 3M Lava Software | Straumann Software |
|---------------------------------------------|-----------------------|------------------|--------------------|
| Principles of Operation: | | | |
| · Entering and<br>Reviewing Patient<br>Data | Yes | Yes | Yes |
| · Scanning | Yes | Yes | Yes<br>● |
| · Data Review and | Yes | Yes | Yes |
| Editing | | | |
| · Data Transfer | Yes | Yes | Yes |
| | | ● | |
| · System Operation and | Yes | Yes | Yes |
| Process Management | � | � | |
| · Abutment Design and | No | No | Yes |
| Manufacturing | | | |

#### Test Results:

Results of verification/validation testing demonstrate that iTero Software showed conformity with pre-established specifications and acceptance criteria. The acceptance criteria were established in order to demonstrate that iTero Software is safe and effective for its intended use.

#### Conclusion:

Based on the intended use, product, performance, and software information provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate devices identified.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 26, 2013

Cadent, Limited An Align Technology Company C/O Mr. Manas M. Lele Regulatory Affairs Analyst 2560 Orchard Parkway San Jose, California 95131

Re: K131101

Trade/Device Name: iTero Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Il Product Code: NHA, NOF Dated: July 26, 2013 Received: July 29, 2013

Dear Mr. Lele:

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. 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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Page 2 - Mr. Lele

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.

Sincerely vours.

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K131101

Device Name: iTero Software

Indications for Use:

iTero software is used with the iTero scanner in capturing 3D digital impressions of teeth, oral soft tissue and structures, and bite relationship. iTero software controls the processing of the data, facilitating the integration of data, and exporting of the data for CAD/CAM fabrication of dental restorations, orthodontic devices, abutments, and accessories. In addition to scan data, various patient and case information can be imported/exported or used for simulation purposes. Other functions are available for verification and service of the system and to serve as an order management tool.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Sheena A. Green 2013.08.26 11:31:23 =04'00'

for M. Susan Runner, DDS, MA

(Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 510 (k) Number: K131101