Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image processing and data management for dental impressions, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device is described as software used for capturing 3D digital impressions and processing data for CAD/CAM fabrication, planning, and simulation. It does not exert any direct therapeutic action on the patient.

Diagnostic

No
The device is described as capturing and processing 3D digital impressions for CAD/CAM fabrication of dental restorations and orthodontic devices, and for planning and simulation, rather than diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the software is "used with the iTero scanner," indicating a dependency on a hardware component (the scanner) for its primary function of capturing 3D digital impressions. While the software processes and exports data, it is not a standalone software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the iTero software is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
iTero software function: The iTero software is used with a scanner to capture 3D digital impressions of teeth and oral structures. It processes this data for the fabrication of dental devices.
Lack of biological sample analysis: The software does not analyze biological samples from the patient. Its function is based on capturing and processing physical impressions of the oral cavity.

Therefore, the iTero software falls under the category of a dental imaging and design software, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

NHA, NOF

Device 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

3D digital impressions (from iTero scanner)

Anatomical Site

teeth, oral soft tissue and structures, and bite relationship.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.

Key Metrics

Not Found

Predicate Device(s)

K062493, K093113

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3630 Endosseous dental implant abutment.

(a)
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.(b)
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.)

Summary

0

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: (408) 789-1550 Fax: (408) 470-1011 Email: miele@aligntech.com

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.

1

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

2

Characteristic	Cadent iTero Software	3M Lava Software	Straumann Software
Principles of Operation:
· Entering and
Reviewing Patient
Data	Yes	Yes	Yes
· Scanning	Yes	Yes	Yes
●
· 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.

3

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.

4

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

5

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