The TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for serew-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

· Zimmer TSV 3.7, 4.1. 4.7. 6.0 mm (3.5. 4.5, 5.7mm platform sizes)
All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.

Device Description

TruBase S consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment.
TruBase S abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (4.3, 5.3, 6.5 mm) and four gingival heights (0.8, 1.8, 2.8, 3.8mm), all having a 4.7mm prosthetic post height. They also feature:

cylindrical shape
hexagonal indexing at the apical end of the connection
indexing guide in the cementable portion for coping fitting
The CAD/CAM patient-specific superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.
TruBase S is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the TruBase S.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental implant abutment, TruBase S, and details the non-clinical testing performed to establish its substantial equivalence to predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of a clinical trial or a full performance study with human subjects, AI systems, or ground truth established by experts as would be typical for an AI/ML medical device.

The information primarily focuses on mechanical testing, material equivalence, and compatibility, which are acceptance criteria for this type of medical device's safety and effectiveness.

Here's a breakdown of the available information based on your request, with an emphasis on what is not present in the document.

1. A table of acceptance criteria and the reported device performance:

The document doesn't present a table of acceptance criteria with specific numerical performance metrics in the way you might expect for an AI/ML device (e.g., sensitivity, specificity). Instead, it states that tests met "the criteria of the standard" or "demonstrated substantial equivalence."

Acceptance Criteria Category	Reported Device Performance	Comments
Fatigue Test (ISO 14801:2016)	"The results of the fatigue test have met the criteria of the standard, ISO 14801:2016, and demonstrated the substantial equivalence with the predicate device."	This implies meeting a predefined mechanical strength and durability threshold for dental implants. Specific numerical fatigue limits are not provided.
End User Steam Sterilization Test (ISO 17665-1:2006, 17665-2:2009, ANSI/AAMI ST79:2010)	"Below tests were performed for predicate device, K152559 and leveraged for the subject device" and it indicates "Equivalent" for sterility and end-user sterilization.	The subject device relies on predicate device testing and demonstrates equivalence in sterilization methods. Specific test results are not detailed for the subject device itself; the equivalence is based on the final sterilization by the user.
Biocompatibility Tests (ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010)	"Below tests were performed for predicate device, K152559 and leveraged for the subject device" and states that "all materials are shown to be biocompatible."	The subject device leverages biocompatibility data from predicate devices, implying similar material properties and safety.
Dimensional Analysis and Reverse Engineering	"The testing demonstrated implant-to-abutment-to-mesostructure compatibility and has established substantial equivalency of the proposed device with predicate devices."	Confirms mechanical fit and compatibility with specified implant systems.
Software Verification and Validation Testing (Sirona Dental CAD/CAM System)	"The subject TruBase S was verified and validated with respect to its functionality and design using the Sirona validated workflow." and "The recommended CAD/CAM System is the same used for the primary predicate device and the validation performed was based on the validation presented by the manufacturer of the primary predicate device."	Confirms that the device works correctly within the established CAD/CAM workflow, relying on prior validation for the software system.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document refers to "non-clinical testing" for the TruBase S and leverages results from predicate devices for other tests. These are likely laboratory or bench tests on physical samples rather than patient data.

Sample size for test set: Not explicitly stated as "test set" in the context of patient data. For mechanical fatigue testing, "worst-case scenario (smallest diameter with maximum angulation)" implies a specific configuration of a few physical samples, but the exact number isn't provided.
Data provenance: Not applicable in the context of patient data. The tests are non-clinical, likely conducted in a lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is a passive dental component, and its evaluation relies on engineering standards and mechanical testing, not a clinical interpretation by human experts establishing ground truth from patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There's no clinical imaging or diagnostic data requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This document does not pertain to an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is not an AI/ML algorithm. The "software" mentioned is CAD/CAM software used for design and manufacturing, not an AI for diagnosis or treatment planning. The device itself is a physical dental abutment.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this type of device is established by adherence to recognized engineering standards (e.g., ISO 14801:2016 for fatigue, ISO 10993 for biocompatibility) and dimensional compatibility with existing implant systems. There is no biological or expert consensus "ground truth" as you would find for diagnostic devices.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that uses a training set.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 11, 2018

TruAbutment Inc. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K171532

Trade/Device Name: TruBase S Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 4, 2018 Received: September 10, 2018

Dear April Lee:

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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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 (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting 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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Indications for Use

510(k) Number (if known) K171532

Device Name TruBase S

Indications for Use (Describe)

· Zimmer TSV 3.7, 4.1. 4.7. 6.0 mm (3.5. 4.5, 5.7mm platform sizes)
All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.

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) Summary

Official Correspondent

Phone: 1-909-274-9971 Fax: 1-909-460-8122

Email: withus6664@gmail.com

Withus Group Inc.

Irvine, CA 92620

April Lee

USA

106 Superior,

Submitter

TruAbutment Inc. Brandon Kim 17742 Cowan, Irvine, CA 92614 USA Email: Brandon.kim@truabutment.com Phone: 1-714-956-1488

Device Information

Trade Name: TruBase S
Common Name: Endosseous dental implant abutment
Classification Name: Abutment, Implant, Dental, Endosseous
Product Code: NHA
Panel: Dental ●
Regulation Number: 21 CFR 872.3630 .
Device Class: Class II
Date prepared: 09/04/2018 ●

Predicate Devices

The subject device is substantially equivalent to the following predicate device:

Primary Predicate
- O Straumann® Variobase® for CEREC® (K151324)
Reference Predicate
- O Neodent Implant System Titanium Base for CEREC® (K160964)
- Link Abutment for CEREC® (K160519) O

Device Description

TruBase S abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (4.3, 5.3, 6.5 mm) and four gingival heights (0.8, 1.8, 2.8, 3.8mm), all having a 4.7mm prosthetic post height. They also feature:

cylindrical shape
hexagonal indexing at the apical end of the connection ●

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indexing guide in the cementable portion for coping fitting ●
The CAD/CAM patient-specific superstructure that composes the final abutment must be designed and milled through the Sirona Dental CAD/CAM System, according to the prosthetic planning and patient clinical situation.

TruBase S is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the TruBase S.

TruBase S is compatible with the following devices:

Dental Implant

. Zimmer TSV - 3.7, 4.1, 4.7, 6.0 mm (3.5, 4.5, 5.7mm platform sizes) cleared under K133339, K113753, K112160, K111889, K101880, K101977, and K072589.

Raw material blank

InCoris Zi (ZrO2) by Sirona Dental Systems GmbH. L size blanks, cleared under K123664. ●

Software

Sirona Dental CAD/CAM System, by Sirona Dental Systems GmbH, cleared under K111421.

No change has been made in the software, its settings or configuration, as well as any modification in the workflow. Sirona inLab software or Sirona CEREC® Software are to be used to design the prosthesis structure according to the previous prosthetic planning. Therefore, the users are required to use the device models (3D models) and the workflow defined and validated by Sirona through K111421, according to the Instruction for Use of TruBase S.

Indication for Use

The TruBase S is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

Zimmer TSV 3.7, 4.1, 4.7, 6.0 mm (3.5, 4.5, 5.7mm platform sizes) ●
All digitally designed abutments and/or coping for use with the TruBase S are to be designed using Sirona inLab software or Sirona CEREC Software and manufactured using a Sirona CEREC or inLab MCX or MC XL milling unit.

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Summary of Technological Characteristics

Both the subject and the reference devices have the same indication of providing support for prostheses. All devices are pre-manufactured titanium bases made of titanium (Ti-6AI-4V ELI), designed to be used as a base when fabricating a CAD/CAM patient-specific superstructure and are compatible with the same CAD/CAM system and blocks of raw material. A clinician or dental laboratory equipped with the Sirona Dental CAD/CAM System will design and mill the patient-specific superstructure, which composes the final medical device after the bonding to TruBase S.

The subject devices differ from the primary predicate devices cleared under K151324 only in the portion of implant connection, which is specific for each manufacturer. The cementable portion is identical and compatible with the Sirona Dental CAD/CAM System and the blocks of raw material. In the end of this section a comparison between the features of subject device and its predicate devices is shown in a tabular format.

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Comparison between Proposed Device and Predicates

Attributes	Proposed Device	Predicate Device	Reference Device #1	Reference Device #2	EQUIVALENCE
Trade Name	TruBase S	Straumann® Variobase® forCEREC® (K151324)	Neodent Implant SystemTitanium Base forCEREC® (K160964)	Link Abutment for CEREC®(K160519)	DISCUSSION
Indications forUse	The TruBase S is a titaniumcomponent that is directlyconnected to endosseous dentalimplants to provide support forpatient-specific prostheticrestorations, such as copings orcrowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridgerestorations. It is compatible withthe following systems:· Zimmer TSV - 3.7, 4.1, 4.7, 6.0mm (3.5, 4.5, 5.7mm platformsizes)All digitally designed abutmentsand/or coping for use with theTruBase S are to be designed usingSirona inLab software or SironaCEREC Software and manufactureusing a Sirona CEREC or inLabMCX or MC XL milling unit.	The Straumann® Variobase®for CEREC® are titanium alloyabutments placed ontoStraumann dental implants toprovide support for customizedprosthetic restorations.Straumann® Variobase® forCEREC® abutments areindicated for screw-retainedsingle tooth or cement-retainedsingle tooth and bridgerestorations.All digitally designed copingsand/or crowns for use with theStraumann® Variobase® forCEREC® abutments are to bedesigned using Sirona inLabsoftware (Version 3.65) orSirona CEREC Software(Version 4.2) and manufacturedusing a Sirona CEREC or inLabMC X or MC XL milling unit.	The Titanium Base forCEREC is a titaniumcomponent that is placedover Neodent Implants toprovide support for customprosthetic restorations, suchas copings or crowns. It isindicated for single-toothscrew-retained restorations.All digitally designedcopings and/or crowns foruse with the NeodentTitanium Base for CERECare to be designed usingSirona inLab software orSirona CEREC Softwareand manufactured using aSirona CEREC or inLabMC X or MC XL millingunit.	The Link Abutment for CERECis titanium alloy abutmentsplaced onto HIOSSEN dentalimplants to provide support forcustomized prostheticrestorations. Link Abutment forCEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridgerestorations.• Link abutment for CERECAll digitally designed copingsand/or crowns for use with theLink abutment for CEREC is tobe scanned using Sirona CERECAC or CEREC AF or CERECAI, designed using Sirona inLabsoftware (Version 3.65) orSirona CEREC Software(Version 4.2) and manufacturedusing a Sirona CEREC or inLabMC X or MC XL milling unit.CAD/CAMmanufacturing/milling occurs atdental laboratories per the designlimitations of the SironaCEREC.	EquivalentThe basic indication ofproviding support forprostheses is identical. Alldevices are CAD/CAMabutment design to beused as a base whenfabricating a patient-specific superstructure.The subject devices arecompatible with the sameCAD/CAM System as theprimary predicate device.
AbutmentDiameter(s)	4.3, 5.3, 6.5 mm	4.5 to 7.0 mm	4.65 mm	4.5 mm	EquivalentSubject devices diameter iswithin the range of diametersfor the primary predicatedevices and does notrepresent a worst case interms of performance.
AbutmentHeight(s)	4.7 mm	4.7 mm	4.7 mm	4.7 mm	Identical
Material ofAbutment	Ti-6Al-4V ELI	Titanium-AluminumNiobiumalloy (Ti-6Al-7Nb)	Titanium-aluminumvanadium alloyTi-6Al-4V	Titanium Alloy	EquivalentThe subject and referencedevices are made of the sametitanium alloy; the titaniumalloy of the primary predicatedevice differs, but thestrength of the materials isdemonstrated via dynamicfatigue testing. Also, allmaterials are shown to bebiocompatible.
Implant-to-AbutmentConnection(s)	• Internal hex	RN (Regular Neck), WN (WideNeck), NC (Narrow CrossFit), andRC (Regular CrossFit)	Morse taper (CM) interface	Morse taper internal connectionMini (Hex, non-Hex)Regular (Hex, non-Hex)	EquivalentThe implant-to-abutmentconnections of TruBase Sand Straumann devices arenot identical, but equivalentbecause of the compatibilitywith the identified Zimmerimplant body.
Compatibility	Zimmer 3.5mm, 4.5mm, 5.7mmplatform sizes	Straumann implant lines, asindicated by the implant-toabutment interfaces.	Morse taper (CM) implantlines of Neodent ImplantSystem.	HIOSSEN dental implants; ETIIISA Fixture ETIII SA Ultra-WideFixture ETIII SA Fixture	EquivalentThe implant-to-abutmentconnections of TruBase Sand Straumann devices arenot identical, but equivalentbecause of the compatibilitywith the identified Zimmerimplant body.
Retention	Screw-retained	Screw-retained or cement retained	Screw-retained	Screw-retained	EquivalentSubject device mode ofattachment is more restrictiveand is within the scope of theprimary predicate device'smode of attachment.
RestorativeRange ofAngulation	Up to 20°	Up to 20°	Up to 20°	Up to 20°	IdenticalThe restoration angulation isidentical among the devicesthat use Sirona DentalCAD/CAM System
Material ofSuperstructure	inCoris ZI meso (K123664)	ZirconiaIPS e-max CADPMMA	ZirconiaIPS e-max CAD	Currently available: inCoris ZImeso (K123664) Ivoclar IPS e.maxCAD (K132209) Ivoclar Telio CAD(K093708)	EquivalentThe range of materialscleared for use with theprimary predicate andreference devices is withinthe scope of materialsindicated for the subjectdevices.
Patient-SpecificDesign	CAD/CAM manufacturedsuperstructures	CAD/CAM manufacturedsuperstructures	CAD/CAM manufacturedsuperstructures	CAD/CAM manufacturedsuperstructures	Identical
Manufacturingwork-flow	Sirona Dental CAD/CAM System	Sirona Dental CAD/CAM System	Sirona Dental CAD/CAMSystem	Per the Sirona CEREC MC X andMC XL milling systems	EquivalentThe subject devicemanufacturing work-flow isthe same of the primarypredicate device workflow
Sterility	Delivered non-sterile.; To be sterilizedby user after superstructurecementation, before placed in patientmouth.	Delivered non-sterile.: To besterilized by user aftersuperstructure cementation, beforeplaced in patient mouth.	Delivered sterile by EOexposure. To be sterilized byuser after superstructurecementation, before placed inpatient mouth.	Delivered non-sterile.; To besterilized by user after superstructurecementation, before placed inpatient mouth.	EquivalentAlthough TruBase S and onereference device is providedin different sterilizationconditions, all finalabutments must be sterilizedby steam before be placed inpatient mouth.
End-UserSterilization	Moist steam sterilization	Moist steam sterilization	Moist steam sterilization	Moist steam sterilization	Identical

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Any differences in technology characteristics are accompanied by information that device is substantially equivalence as the predicate.

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Non-clinical Testing

The subject device was tested to evaluate its substantial equivalence according to the following standards.

Fatigue Test according to ISO 14801:2016 ●
Below tests were performed for predicate device, K152559 and leveraged for the subject device:
End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ● ANSI/AAMI ST79:2010.
Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-● 10:2010.

Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device. The results of the above tests have met the standard, and demonstrated the substantial equivalence with the predicate device.

Mechanical Testing

Mechanical Testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing. The fatigue limit demonstrates the substantial equivalence. The results of the fatigue test have met the criteria of the standard, ISO 14801:2016, and demonstrated the substantial equivalence with the predicate device.

Dimensional analysis and reverse engineering

Dimensional analysis and reverse engineering the OEM implant body, OEM implant abutment and OEM abutment fixation screw including all the connection platforms (implant-to-abutment-tomesostructure) were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible implant body as well as the OEM implant abutment and implant body. The testing demonstrated implantto-abutment-to-mesostructure compatibility and has established substantial equivalency of the proposed device with predicate devices.

Software Verification and Validation Testing

The recommended software was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator. Therefore, the subject TruBase S was verified and validated with respect to its functionality and design using the Sirona validated workflow. The recommended CAD/CAM System is the same used for the primary predicate device and

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the validation performed was based on the validation presented by the manufacturer of the primary predicate device.

Note: TruAbutment makes no changes to the software, its setting or configuration, as well as no modification in the workflow defined and validated by Sirona per K111421. The Sirona software is recommended because of the compatibility of its existing 3D models with the subject device. Clinical testing was not necessary to establish substantial equivalency of the device.

Conclusion: TruBase S constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate devices. Therefore, TruBase S and its predicates are substantially equivalent.

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.)