SIMPLANT Pro

General Information

Technologies must be operated and maintained in accordance with Federal and Department security and privacy policies and guidelines. More information on the proper use of the TRM can be found on the TRM Proper Use Tab/Section.

Website:	Go to site
Description:	SIMPLANT Pro is a computer-guided dental implant treatment technology. This dental planning technology provides users with implant placement guidance using three-dimensional (3D) diagrams and custom-made stereo lithographic drill guides. Plans created by SIMPLANT assess surgical and prosthetic aspects such as bone volume and quality, neighboring teeth, the alveolar nerve, and sinuses. Multiple users can view a proposed plan, including the dental laboratory and the patient who will all see what an implant plan entails. This technology does not use a database to store data.
Technology/Standard Usage Requirements:	Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.
Section 508 Information:	This technology qualifies for a legally-defined Exception (Fundamental Alteration) as determined by the Section 508 Office and will not need a 508 assessment prior to being available in the TRM. For additional information or assistance regarding Section 508, please contact the Section 508 Office at Section508@va.gov.
Decision:	View Decisions

Decision Source:	TRM Mgmt Group
Decision Process:	One-VA TRM v22.11
Decision Date:	11/23/2022 at 22:12:32 UTC
Introduced By:	TRM Request
Vendor Name:	Dentsply Implants

Vendor Release Information

The Vendor Release table provides the known releases for the TRM Technology, obtained from the vendor (or from the release source).

Version	Release Date	Vendor End of Life Date	Vendor Desupport Date
14
16
17.x	04/30/2015
18.x	12/31/2017

Current Decision Matrix (11/03/2022)

Users must ensure their use of this technology/standard is consistent with VA policies and standards, including, but not limited to, VA Handbooks 6102 and 6500; VA Directives 6004, 6513, and 6517; and National Institute of Standards and Technology (NIST) standards, including Federal Information Processing Standards (FIPS). Users must ensure sensitive data is properly protected in compliance with all VA regulations. Prior to use of this technology, users should check with their supervisor, Information Security Officer (ISO), Facility Chief Information Officer (CIO), or local Office of Information and Technology (OI&T) representative to ensure that all actions are consistent with current VA policies and procedures prior to implementation.

The VA Decision Matrix displays the current and future VA IT position regarding different releases of a TRM entry. These decisions are based upon the best information available as of the most current date. The consumer of this information has the responsibility to consult the organizations responsible for the desktop, testing, and/or production environments to ensure that the target version of the technology will be supported. Any major.minor version that is not listed in the VA Decision Matrix is considered unapproved for use.

Legend:

White	Approved: The technology/standard has been approved for use.
Yellow	Approved w/Constraints: The technology/standard can be used within the specified constraints located below the decision matrix in the footnote[1] and on the General tab.
Gray	Unapproved: This technology or standard can be used only if a POA&M review is conducted and signed by the Authorizing Official Designated Representative (AODR) as designated by the Authorizing Official (AO) or designee and based upon a recommendation from the POA&M Compliance Enforcement, has been granted to the project team or organization that wishes to use the technology.
Orange	Divest: VA has decided to divest itself on the use of the technology/standard. As a result, all projects currently utilizing the technology/standard must plan to eliminate their use of the technology/standard. Additional information on when the entry is projected to become unapproved may be found on the Decision tab for the specific entry.
Black	Prohibited: The technology/standard is not (currently) permitted to be used under any circumstances.
Blue	Planning/Evaluation Constraint:The period of time this technology is currently being evaluated, reviewed, and tested in controlled environments. Use of this technology is strictly controlled and not available for use within the general population. If a customer would like to use this technology, please work with your local or Regional OI&T office and contact the appropriate evaluation office displayed in the notes below the decision matrix. The Local or Regional OI&T office should submit an inquiry to the TRM if they require further assistance or if the evaluating office is not listed in the notes below.

Release/Version Information:

VA decisions for specific versions may include a ‘.x’ wildcard, which denotes a decision that pertains to a range of multiple versions.

For example, a technology approved with a decision for 7.x would cover any version of 7.(Anything) - 7.(Anything). However, a 7.4.x decision would cover any version of 7.4.(Anything), but would not cover any version of 7.5.x or 7.6.x on the TRM.

VA decisions for specific versions may include ‘+’ symbols; which denotes that the decision for the version specified also includes versions greater than what is specified but is not to exceed or affect previous decimal places.

For example, a technology approved with a decision for 12.6.4+ would cover any version that is greater than 12.6.4, but would not exceed the .6 decimal ie: 12.6.401 is ok, 12.6.5 is ok, 12.6.9 is ok, however 12.7.0 or 13.0 is not.

<Past

CY2028

CY2029

CY2030

Future>

Release

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

Q1

Q2

Q3

Q4

14

Unapproved

16

Unapproved

17.x

Unapproved

18.x

Approved w/Constraints
[5, 9]

Decision Constraints


[1]	Veterans Affairs (VA) users must ensure VA sensitive data is protected properly in accordance with VA Handbook 6500 and the Federal Information Security Management Act (FISMA). Per VA Handbook 6500, Federal Information Processing Standards (FIPS) 140-2 certified encryption must be used to protect and encrypt data in transit and at rest if Personally Identifiable Information/Protected Health Information/VA (PII/PHI/VA) sensitive information is involved. If FIPS 140-2 certified encryption is not used, additional mitigating controls must be documented in an approved System Security Plan (SSP). In addition, the technology must be implemented within the VA production network (not in a Demilitarized Zone (DMZ)), unless the specific uses and instances of the technology are approved by the Enterprise Security Change Control Board (ESCCB). All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500. In cases where the technology is used for external connections, a full ESCCB review is required in accordance VA Directive 6004, VA Directive 6517 and VA Directive 6513.

[2]	As of April 23, 2015, per the Deputy CIO of Architecture, Strategy and Design (ASD), all technologies in use by the VA require an assessment by the VA Section 508 office. Section 508 of the Rehabilitation Act Amendments of 1998 is a federal law that sets the guidelines for technology accessibility. A VA Section 508 assessment of this technology has not been completed at the time of publication. Therefore, as of April 23, 2015 only users of this technology who have deployed the technology to the production environment, or have project design and implementation plans approved, may continue to operate this technology. In the case of a project that has implemented, or been approved for a specific site or number of users, and that project needs to expand operations to other sites or to an increased user base, it may do so as long as the project stays on the existing version of the technology that was approved or implemented as of April 22, 2015. Use of this technology in all other cases is prohibited.

[3]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[4]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[5]	Technology must remain patched and operated in accordance with Federal and Department security policies and guidelines in order to mitigate known and future security vulnerabilities.

[6]	Users must ensure that Microsoft Internet Explorer (IE) is implemented with VA-approved baselines. (refer to the ‘Category’ tab under ‘Runtime Dependencies’)

[7]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISO (Information Security Officer) to ensure compliance with VA Handbook 6500.

[8]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISSO (Information System Security Officer) to ensure compliance with VA Handbook 6500.

[9]	Veterans Affairs (VA) users must ensure VA sensitive data is properly protected in compliance with all VA regulations. All instances of deployment using this technology should be reviewed by the local ISSO (Information System Security Officer) to ensure compliance with both VA Handbook 6500 and VA Directive 6500.

Note:

At the time of writing, version 18.5 is the most current version released.

References

The following reference(s) are associated with this entry:
Type	Name	Description
Other	Simplant Pro Procedure Manual	This document links to the user guide for this technology.
Other	Simplant 18 Instructions for Use	This document links to the installation and user guide for the most current version of this technology.
Vendor Provided*	GUIDED SURGERY Simplant	This website links to another product site for this technology that shows the most current versioning available.
*NOTE: Vendor provided information is subject to the accuracy of the manufacturer.

Technology Components

Note: This list may not be complete. No component, listed or unlisted, may be used outside of the technology in which it is released. The usage decision for a component is found in the Decision and Decision Constraints.
Name	Description
SIMPLANT Implant Library	This library can assist as a surgical and clinical guide.

VA Categories View the VA Categorization Framework

Domain Area	Category	Customer Guidance	Category Locked By ELT Date
Health Care Health Services	Dentistry

Operating Systems Supported by the Technology

macOS - Approved w/Constraints
Windows Client - Approved w/Constraints
Windows Server - Approved w/Constraints

Technologies/Standards Relationships

Runtime Dependencies:

No runtime dependencies have been identified.

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

This is a mature technology.
At the time of writing, no National Institute of Standards and Technology (NIST) vulnerabilities had been reported and no VA Cyber Security Operations Center (CSOC) bulletins had been issued for the latest versions of this technology.
This technology may improve productivity for specific staff whose responsibilities include placement guidance for dental implants.
This is a well-documented technology.

Adoption Risks

Due to the rapid release schedule of this technology, the VA may be unable to update to the most recent patch and may require a deployment model requiring the use of specific versions.
There are other approved solutions that provide similar functionality available on the TRM. The use of several similar solutions may increase organization requirements for support and maintenance.
The potential exists to store Personally Identifiable Information (PII), Protected Health Information (PHI) and/or VA Sensitive data and proper security standards must be followed in these cases.

Architectural Benefits

This technology is portable as it runs on multiple TRM-approved operating systems.
SIMPLANT is compatible with several implants as well as all Digital Imaging and Communications in Medicine (DICOM) compatible computerized tomography (CT) scanners and major optical and intraoral scanners.

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General Information

Vendor Release Information

Current Decision Matrix (11/03/2022)

Decision Constraints

References

Technology Components

VA Categories View the VA Categorization Framework

Operating Systems Supported by the Technology

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

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Architectural Benefits

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VA Technical Reference Model v 24.7

General Information

Vendor Release Information

Current Decision Matrix (11/03/2022)

Decision Constraints

References

Technology Components

VA Categories View the VA Categorization Framework

Operating Systems Supported by the Technology

Technologies/Standards Relationships

Runtime Dependencies:

Comparable Technologies:

Companion Technologies/Supported Standards:

General Analysis

Adoption Benefits

Adoption Risks

Architectural Benefits

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