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

• NobelActive (K102436, K071370, K133731): 3.0, 3.5, 4.3, 5.0, 5.5 (3.0, NP, RP, WP)

All digitally designed abutments and/or copings for use with TruBase S are intended to be sent to a TruAbutmentvalidated milling center for manufacture.

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. The system also includes a TruBase S Screw for fixation to the implant body.

TruBase S abutments are made of titanium alloy conforming to ASTM F 136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (NobelActive 3.0, NP, RP, WP). The TruBase S Screws are composed of titanium alloy per ASTM F136.

They also feature:

. cylindrical shape
hexagonal indexing at the apical end of the connection ●
indexing guide in the cementable portion for coping fitting ●

CAD/CAM customized superstructure that composes the final abutmentis intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

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

AI/ML Overview

The provided document describes a 510(k) premarket notification for a dental implant abutment, TruBase S. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness. As such, the information you're looking for regarding AI-specific criteria, clinical study designs, human reader performance, or training set details associated with an AI-driven device is largely not present in this document.

However, I can extract the acceptance criteria and study details relevant to the mechanical performance and substantial equivalence of this medical device.

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

The acceptance criteria for mechanical performance are implicitly set by compliance with ISO 14801:2016 for fatigue testing. The document states that the test results "met the criteria of the standard." For design parameters, the acceptance criteria are substantial equivalence to the predicate device, K201197.

Acceptance Criteria Category	Specific Acceptance Criterion	Reported Device Performance
Material	Ti-6Al-4V ELI (ASTM F 136) for Abutment and Screw	Complies: TruBase S abutments are made of titanium alloy conforming to ASTM F 136. TruBase S Screws are composed of titanium alloy per ASTM F136.
Design Parameters (CAD)	Minimum and Maximum abutment angle (°) : 0~15	0~15
	Minimum and Maximum Cuff Height (mm): 0.5~5.0	0.5~5.0
	Minimum and Maximum diameter at abutment/implant interface (Ø, mm): 5.0~8.0	5.0~8.0
	Minimum Thickness (mm): 0.4	0.4
	Minimum and Maximum length of abutment post (length above the abutment collar/gingival height) (mm): 4.0~6.0	4.0~6.0
Mechanical Performance	Fatigue testing according to ISO 14801:2016 requirements	"The results of the above tests have met the criteria of the standard." "The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."
	Implant-to-abutment compatibility	"The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices." (Through dimensional analysis and reverse engineering)
Sterilization	End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.	Leveraged from predicate device (K201197), which performed these tests with results meeting criteria. TruBase S is provided non-sterile and must be sterilized.
Biocompatibility	Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.	Leveraged from predicate device (K201197), which performed these tests with results meeting criteria. As the materials are the same (Ti-6Al-4V ELI and InCoris Zi), the biocompatibility is assumed to be equivalent.

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 does not specify a distinct "test set" in the context of an AI-driven device or clinical study. The testing performed was non-clinical mechanical performance testing on physical devices and based on technical specifications and design parameters.

Sample Size: For the fatigue testing, the document mentions "worst-case constructs" were subjected to testing, and "the fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient." However, specific numerical sample sizes for these tests are not provided.
Data Provenance: The data originates from internal non-clinical testing conducted by the manufacturer or accredited labs for mechanical and material properties. No country of origin is specified for these tests. The nature of these tests is prospective in the sense that they are conducted specifically for the submission, but they are not clinical studies.

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)

This information is not applicable. The device is a physical dental implant abutment, not an AI device that requires expert ground truth labeling for image analysis or diagnostic purposes. The "ground truth" for its performance is established through adherence to engineering standards (ISO 14801) and material specifications (ASTM F 136).

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or studies where human interpretation of data (e.g., medical images) is compared with an AI's output, often involving multiple experts to resolve discrepancies. This device's evaluation relies on objective mechanical and material testing, not human interpretation or 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

This information is not applicable. This device is a physical dental implant abutment and is not an AI-driven diagnostic or assistive device that would participate in an MRMC study.

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

This information is not applicable. This device is a physical dental implant component, not an algorithm.

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

The "ground truth" for this medical device is based on:

Material Specifications: Adherence to ASTM F 136 for titanium alloy.
Engineering Standards: Compliance with ISO 14801:2016 for fatigue testing, and ISO 17665-1/2 and ANSI/AAMI ST79 for sterilization.
Biocompatibility Standards: Compliance with ISO 10993 series.
Dimensional and Design Parameters: Matching the design limits established by the predicate device and compatible OEM implant lines.

8. The sample size for the training set

This information is not applicable. There is no concept of a "training set" for this physical medical device. Manufacturing processes are based on established engineering principles and quality control, not machine learning training.

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

This information is not applicable, as there is no training set for this physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

TruAbutment Inc. Chris Choi Director 17742 Cowan Irvine, California 92614

Re: K201842

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: April 22, 2021 Received: May 4, 2021

Dear Chris Choi:

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-reportingcombination-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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Device Name TruBase S

Indications for Use (Describe)

• NobelActive (K102436, K071370, K133731): 3.0, 3.5, 4.3, 5.0, 5.5 (3.0, NP, RP, WP)

All digitally designed abutments and/or copings for use with TruBase S are intended to be sent to a TruAbutmentvalidated milling center for manufacture.

TruBase S is compatible with the following devices:

NobelActive (K102436, K071370, K133731)

Implant Body Diameter 3.0 / Implant Platform 3.0 / Connection Type: Internal Hex

Implant Body Diameter 3.5 / Implant Platform NP / Connection Type: Internal Hex

Implant Body Diameter 4.3 / Implant Platform RP / Connection Type: Internal Hex

Implant Body Diameter 5.0 / Implant Platform RP / Connection Type: Internal Hex

Implant Body Diameter 5.5 / Implant Platform WP / Connection Type: Internal Hex

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is written in white letters on a blue background. The letters "ru" are written in a larger, blue font and are placed below the word "Abutment". To the left of the letters "ru" is a blue image of a screw.

510(k) Summary

K201842

Submitter TruAbutment Inc. HoSu Lee 17742 Cowan, Irvine, CA 92614 USA Email: hosu.lee@truabutment.com Phone: 1-714-956-1488

Official Correspondent

TruAbutment Inc. Chris Choi 17742 Cowan, Irvine, CA 92614 USA Email: chris.choi(@truabutment.com Phone: 1-714-956-1488

Trade Name: TruBase S
Common Name: Endosseous dental implant abutment
Classification Name: Abutment, Implant, Dental, Endosseous
Product Code: NHA
Panel: Dental .

Device Information

Regulation Number: 21 CFR 872.3630
Device Class: Class II ●
Date prepared: 06/03/2021 ●

Primary Predicate Device/ Reference Devices:

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

Primary Predicate Device:

TruAbutment DS, TruBase S (K201197) by TruAbutment Inc. ●

Reference Devices:

. Nobelactive 3.0 (K102436) By NobelBiocare.
Nobelactive Internal Connection Implant (K071370) By Nobel Biocare.
Nobelactive Wide Platform (Wp) (K133731) By Nobel Biocare.

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Image /page/4/Picture/0 description: The image shows a logo for a company called "Abutmentru". The logo is primarily blue and white. The word "Abutment" is written in white at the top of the logo, and the letters "ru" are written in a large blue font below the word "Abutment". The "r" in "ru" is stylized to look like a screw.

General Description

TruBase S

They also feature:

. cylindrical shape
hexagonal indexing at the apical end of the connection ●
indexing guide in the cementable portion for coping fitting ●

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

The following table shows the subject device abutment platform sizes for each of the OEM implant lines and sizes.

Implant System	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-Abutment Connection
NobelActive(K102436,K071370,K133731)	3.0	10	36769	3.0
		11.5	36770
		13	36771
		15	36772
	3.5	10	34125	3.5(NP)
		11.5	34126
		13	34127
		15	34128
	4.3	10	34131	3.9(RP)	Internal Hex
		11.5	34132
		13	34133

TruBase S is compatible with the following devices:

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Image /page/5/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized, sans-serif font. The letters are in a bright blue color. The "T" in "ABUTMENT" extends downward, forming a visual element that resembles a screw thread. The letters "RU" are placed to the right of the "T" and are also in blue.

TruAbutmentInc. 17742 Cowan, Irvine, CA 92614

ાર 34134

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Image /page/6/Picture/0 description: The image shows a logo for a company called "Abutment Tru". The word "Abutment" is written in white letters on a blue background. The word "Tru" is written in large, blue letters, with a design that looks like a screw on the left side of the word. The logo has a modern and professional look.

TruAbutmentInc. 17742 Cowan, Irvine, CA 92614

ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)
5.0	10	34137
	11.5	34138	3.9(RP)
	13	34139
	15	34140
5.5	7	37806
	8.5	37807	5.1(WP)
	10	37808
	11.5	37809
	13	37810

Raw material blanks

InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, (same as K201197). ●

Cement

RelyX Unicem 2Automix by 3M ESPE, (same as K201197). .
Design Limitation for Zirconia .

superstructure

Design parameter	Design Limit
Minimum and Maximum abutment angle (°)	0~15
Minimum and Maximum Cuff Height (mm)	0.5~5.0
Minimum and Maximum diameter at abutment/implant interface(Ø, mm)	5.0~8.0
Minimum Thickness (mm)	0.4
Minimum and Maximum length of abutment post(length above the abutment collar/gingival height) (mm)	4.0~6.0

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Image /page/7/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a stylized font at the top. Below "Abutment", the letters "ru" are displayed in a larger, bolder font, with a design resembling the threads of a screw or bolt on the left side of the letters. The overall design is simple and modern, with a focus on the company name and a visual element suggesting engineering or construction.

Indication for Use

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

. NobelActive (K102436, K071370, K133731): 3.0, 3.5, 4.3, 5.0, 5.5 (3.0, NP, RP, WP)
All digitally designed abutments and/or copings for use with TruBase S are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase S is compatible with the following devices:

NobelActive (K102436, K071370, K133731)

Implant Body Diameter 3.0 / Implant Platform 3.0 / Connection Type: Internal Hex Implant Body Diameter 3.5 / Implant Platform NP / Connection Type: Intemal Hex Implant Body Diameter 4.3 / Implant Platform RP / Connection Type: Intemal Hex Implant Body Diameter 5.0 / Implant Platform RP / Connection Type: Intemal Hex Implant Body Diameter 5.5 / Implant Platform WP / Connection Type: Intemal Hex

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Image /page/8/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The logo also includes a graphic element that resembles a screw or bolt, suggesting a connection to engineering or construction.

Summary of Technological Characteristics

The subject device is substantially equivalent to the currently cleared devices. They are substantially equivalent in intended use, material and connection interfaces to the implants are identical for each diameter and connection type. Comparison demonstrating Substantial Equivalence follows at the end of this section.

Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruBase S	TruBase S (K201197)
Indications forUse	TruBase S is a titanium componentthat is directly connected toendosseous dental implants toprovide support for customprosthetic restorations, such ascopings or crowns. It is indicated fora screw-retained single tooth orcement-retained single tooth andbridge restorations. It is compatiblewith the following systems:NobelActive (K102436,K071370, K133731): 3.0, 3.5, 4.3,5.0, 5.5 (3.0, NP, RP, WP) All digitally designed abutmentsand/or copings for use with TruBaseS are intended to be sent to aTruAbutment-validated millingcenter for manufacture.TruBase S is compatible with thefollowing devices:	TruBase S is a titanium componentthat is directly connected toendosseous dental implants toprovide support for customprosthetic restorations, such ascopings or crowns. It is indicated forscrew-retained single tooth orcement-retained single tooth andbridge restorations. It is compatiblewith the following systems:Zimmer 3.1mmD Dental ImplantSystem (K142082) Screw Vent® and Tapered ScrewVent® (K013227) TruBase S is intended to be sent to aTruAbutment-validated millingcenter for manufacture.TruBase S is compatible with the
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruBase S	TruBase S (K201197)
	NobelActive (K102436, K071370,K133731)Implant Body Diameter 3.0 / ImplantPlatform 3.0 / Connection Type:Internal HexImplant Body Diameter 3.5 /Implant Platform NP / ConnectionType: Internal HexImplant Body Diameter 4.3 /Implant Platform RP / ConnectionType: Internal HexImplant Body Diameter 5.0 / ImplantPlatform RP / Connection Type:Internal HexImplant Body Diameter 5.5 / ImplantPlatform WP / Connection Type:Internal Hex	following devices:Zimmer 3.1mmD Dental ImplantSystem(K142082)Implant Body Diameter 3.1/Implant Platform Diameter 2.9 /Internal HexScrew Vent® and Tapered ScrewVent® (K013227)Implant Body Diameter 3.7/Implant Platform Diameter 3.5 /Internal HexImplant Body Diameter 4.1/Implant Platform Diameter 3.5 /Internal HexImplant Body Diameter 4.7/Implant Platform Diameter 4.5 /Internal HexImplant Body Diameter 6.0/ ImplantPlatform Diameter 5.7 / Internal Hex
CAD DesignLimits	Maximum Angulation 0~~15°Maximum Cuff Height 0.5~~5mmMinimum Diameter Ø 5.0~ Ø 8.0mmMinimum Thickness 0.4mmMinimum Post Height 4~6mm	Maximum Angulation 0~~15°Maximum Cuff Height 0.5~~5mmMinimum Diameter Ø 5.0~~Ø 8.0mmMinimum Thickness 0.4mmMinimum Post Height 4~~6mm
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruBase S	TruBase S (K201197)
AbutmentDiameter (s)	Engaging: 3.5, 4.0, 4.5, 4.6, 5.5mmNon-Engaging: 3.5, 4.0, 4.5, 4.6,5.5mm	Engaging: 3.5, 3.8, 4.5, 5.7mmNon-Engaging: 3.5, 4.3, 4.5, 5.3, 5.7,6.5mm
AbutmentHeight (s)	6.7~10.7mm	4.7mm
Material ofAbutment	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Implant-to-AbutmentConnection(s)	Screw-retained to the implant. Theprosthesis can be cement-retained to theabutment.	Screw-retained to the implant.Theprosthesis can be cement-retained to theabutment.
Type ofRetention	Screw-retained	Screw-retained
Material ofSuperstructure	InCoris Zi	InCoris ZI
Manufacturingprocesses	TruAbutment-validated milling center	TruAbutment-validated milling center
End-UserSterilization	Moist steam sterilization	Moist steam sterilization

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Image /page/9/Picture/0 description: The image shows a logo with the word "ABUTMENT" in white letters on a blue background. The "A" in "ABUTMENT" is larger than the other letters. Below the word "ABUTMENT" are the letters "ru" in a large, stylized font, also in blue. The left side of the logo has a jagged edge, resembling the teeth of a gear or screw.

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Image /page/10/Picture/0 description: The image features the word "ABUTMENT" in a stylized, sans-serif font. The letters are white, set against a blue background. The bottom of the image has a jagged edge, resembling the teeth of a gear or a screw thread, adding a mechanical or engineering element to the design.

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Image /page/11/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is primarily blue and white. The word "Abutment" is written in white letters with a blue outline at the top of the logo. Below "Abutment", the letters "ru" are written in a larger, stylized blue font. To the left of the "ru" is a graphic of a screw.

Substantial Equivalence Discussion

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.

The subject device is substantially equivalent in indications and design principles to the primary predicate device and the reference devices listed above. Provided tables are comparing the Indications for Use Statements and the technological characteristics of the subject device and the primary predicate device.

The Indications for Use Statement (IFUS) for the subject device (TruBase S) is substantially equivalent in intended use to the primary predicate device (K201197). All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible.

The Indications for Use Statement (IFUS) for the subject device (TruBase S) is substantially equivalent to that of the primary predicate device (K201197). Slight differences in the language of the subject device and primary predicate device Indications for Use statements do not affect the intended use as an endosseous dental implant abutment for support of a prosthesis to restore chewing function.

The other minor differences are related to the compatible OEM implant lines. None of these minor differences impact substantial equivalence because all IFUS express equivalent intended to use to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.

Also, the primary predicate device follows the same digital workflow and utilizes the same materials (Ti-6Al-4V ELI) and inCoris ZI, as the subject device system.

Design parameter	Subject Device(K201842)	Predicate Device(K201197)
Minimum and Maximumabutment angle (°)	0~15	0~15
Minimum and MaximumCuff Height (mm)	0.5~5.0	0.5~5.0
Minimum and Maximumdiameter atabutment/implant interface(Ø, mm)	5.0~8.0	5.0~8.0

The subject device and the predicate device design parameter are substantially equivalent.

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Image /page/12/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is in blue and white, with the word "Abutment" in a sans-serif font. The logo also includes a stylized image of a screw or bolt. The logo is simple and modern, and it is likely used to represent a company that manufactures or sells screws, bolts, or other fasteners.

Design parameter	Subject Device(K201842)	Predicate Device(K201197)
Minimum Thickness (mm)	0.4	0.4
Minimum and Maximumlength of abutment post(length above the abutmentcollar/gingival height)(mm)	4.0~6.0	4.0~6.0

Mechanical performance testing was performed according to ISO 14801:2016. For compatible OEM implant lines, worst-case constructs were subjected to static compression fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use.

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 (K201197) 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 criteria of the standard, and demonstrated the substantial equivalence with the predicate device.

Comparative fatigue testing of the subject and predicate devices was conducted in accordance with ISO 14801 and 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.

Dimensional analysis and reverse engineering of the implant-to-abutment connection platform 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 OEM implant body, OEM abutment, and OEM fixation screw. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices.

Clinical testing was not necessary to establish substantial equivalency of the device.

Conclusion

The 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 device. Therefore, TruBase S and its predicate 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.)