TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation.
TruBase 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.

Device Description

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for: (1) For fixing into the endosseous implant (2) For dental laboratory use during construction of related restoration. The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.
TruBase 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 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. CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the 3Shape Abutment Designer Software, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.

AI/ML Overview

The provided text describes the regulatory clearance for the TruAbutment DS and TruBase devices, citing substantial equivalence to predicate devices, and includes details about non-clinical testing. However, it does not contain information about a study proving device performance against specific acceptance criteria for AI or algorithmic performance. The studies mentioned are focused on mechanical and biocompatibility testing of the physical dental implant abutments.

Therefore, for aspects related to AI/algorithmic performance, sample sizes, expert ground truth, adjudication, and MRMC studies, the information is not present in the provided document.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The document describes "Design Limitations" for both TruAbutment DS and TruBase, which can be interpreted as design acceptance criteria. It also references compatibility and mechanical performance tests.

TruAbutment DS Design Limitations / Reported Performance:

Design parameter	Acceptance Criteria (Design Limit)	Reported Device Performance
Minimum and Maximum abutment angle	0~25°	- (Meets criteria as per "Conclusion")
Minimum and Maximum Cuff Height	0.5~6.0mm	- (Meets criteria as per "Conclusion")
Minimum and Maximum diameter at the abutment/implant interface	Ø3.8mm~Ø8.0mm	- (Meets criteria as per "Conclusion")
Minimum Thickness	0.4 mm	- (Meets criteria as per "Conclusion")
Minimum and Maximum length of abutment post (length above the abutment collar/gingival height)	4~7 mm	- (Meets criteria as per "Conclusion")

TruBase / Zirconia Superstructure Design Limitations / Reported Performance:

Design parameter	Acceptance Criteria (Design Limit)	Reported Device Performance
Minimum and Maximum abutment angle	0~15°	- (Meets criteria as per "Conclusion")
Minimum and Maximum Cuff Height	0.5~5 mm	- (Meets criteria as per "Conclusion")
Minimum and Maximum diameter at the abutment/implant interface	Ø5.0mm~Ø8.0mm	- (Meets criteria as per "Conclusion")
Minimum Thickness	0.4 mm	- (Meets criteria as per "Conclusion")
Minimum and Maximum length of abutment post (length above the abutment collar/gingival height)	4~6 mm	- (Meets criteria as per "Conclusion")

Mechanical Performance:

Acceptance Criteria: Met the criteria of ISO 14801:2016 and FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments."
Reported Device Performance: "The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use."

Sterilization Validation:

Acceptance Criteria: Met the criteria of ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010.
Reported Device Performance: Achieved through end-user moist steam sterilization.

Biocompatibility:

Acceptance Criteria: Met the criteria of ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
Reported Device Performance: Not explicitly stated as "passed" for the subject device, but mentioned it was leveraged from predicate device testing and supports substantial equivalence.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: For mechanical testing (ISO 14801), "worst-case constructs" were subjected to static compression and compression fatigue testing for each compatible OEM implant line. The exact number of samples is not specified.
Data Provenance: Not specified; the context implies laboratory testing. The document does not refer to real-world patient data for performance evaluation in the context of AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests performed are non-clinical (mechanical, sterilization, biocompatibility) of physical devices, not assessments requiring expert interpretation of data or images.

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

Not applicable for non-clinical, physical device testing.

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

Not applicable. No AI component is described in the performance evaluation section for either TruAbutment DS or TruBase. The software mentioned (3Shape Abutment Designer Software) is for CAD/CAM design, which is a tool for designing the physical device, not an AI for diagnosis or interpretation that would involve human readers.

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

Not applicable. As noted above, the device itself is a physical dental abutment, and its design process involves CAD/CAM software, not a standalone AI algorithm for medical decision-making or image analysis.

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

Mechanical Testing: Ground truth is established by the specified ISO standards (ISO 14801) and FDA guidance, defining acceptable force and fatigue limits for dental implant systems.
Dimensional Analysis: Ground truth is against design specifications and reverse engineering of OEM implant-to-abutment connections.
Sterilization: Ground truth is against ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010 standards for sterilization efficacy.
Biocompatibility: Ground truth is against ISO 10993 standards for biological safety.

8. The sample size for the training set

Not applicable. The document describes a physical medical device and its manufacturing process, not an AI/ML algorithm that requires a training set. The CAD/CAM software aids in design, but the document does not detail its internal development or any associated training sets.

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

Not applicable, as no training set for an AI/ML algorithm is described.

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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 08, 2021

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

Re: K202579

Trade/Device Name: TruAbutment DS, TruBase Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 26, 2021 Received: June 7, 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.

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

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Indications for Use

Device Name TruAbutment DS, TruBase

Indications for Use (Describe)

TruAbutment DS

TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with the following systems:

· Astra Tech Implant System (K101732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)

· Dentium Company Limited Implantium (K041368): 3.4. 3.8. 4.3. 4.8 (Regular)

· PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)

· Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890): 2.9 (SC)

• Straumann® Bone Level Tapered Implants (K140878): 3.3, 4.1, 4.8 (NC, RC)

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

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)	☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use

510(k) Number (if known) K202579

Device Name TruAbutment DS, TruBase

Indications for Use (Describe) TruBase

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

• Astra Tech Implant System (K101732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)

· Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular)
· PrimaConnexTM Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)

· Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890): 2.9 (SC)

· Straumann® Bone Level Tapered Implants (K140878): 3.3, 4.1, 4.8 (NC, RC)

• Xpeed AnyRidge Internal Implant System (K140091): 4.0, 4.4, 4.9, 5.4, 5.9 (3.5)

All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image is a logo for Abutment. The logo is blue and features the word "Abutment" in a stylized font. The "A" is larger than the other letters and is placed above the rest of the word. Below the word "Abutment" is a graphic that resembles a screw or bolt. The logo is simple and eye-catching, and it effectively communicates the company's name and brand.

510(k) Summary K202579

Submitter

TruAbutment Inc. Eunjin Jang 17742 Cowan, Irvine, CA 92614 USA Email: Eunjin.jang@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

Device Information

. Trade Name: TruAbutment DS, TruBase
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: 07/07/2021 ●

Primary Predicate:

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

Reference Devices:

Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111) by Astra Tech, Inc.
Astra Tech Implant System (K101732) by Astra Tech AB.
Dentium Company Limited Implantium (K041368) by Dentium Co., Ltd.
Lifecore PrimaConnexTM Internal Connection Implant System(K051614) by Lifecore Biomedical, Inc.
Xpeed AnyRidge Internal Implant System (K140091) by MegaGen Implant Co., Ltd.
Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) by ● Straumann USA, LLC.
Straumann® Bone Level Tapered Implants (K140878) by Straumann USA, LLC.

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Image /page/5/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is primarily blue and features the word "Abutment" in a stylized font. Below the word "Abutment" is a design that resembles a screw or bolt, also in blue. The logo is simple and modern, with a focus on the company name and a visual element related to engineering or construction.

General Description

TruAbutment DS

(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.

The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

Mechanical resistance of the implant-abutment connection is essential to ensure the correct long-term functional performance of the complete dental restoration. Dimensional compatibility and mechanical performance of bases and screws together with the underlying implant are of primary importance. These concepts are the basis upon which the system design characteristics and functional performance are established.

The TruAbutment DS is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

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

TruAbutment Platform Diameter /Compatible Implant System	TruAbutment DSEngaging	TruAbutment DSNon-Engaging
Astra Tech OsseoSpeed (K101732, K024111)
X-small	o	o
Small	o	o
Large	o	o
Dentium SuperLine (K041368)
Regular	o	o
Keystone PrimaConnex (K051614)
3.5 (SD)	o	o
4.1 (RD)	o	o
5.0 (WD)	o	o
Straumann Bone Level (K162890) (K140878)
SC	o	o
NC	o	o
RC	o	o

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Image /page/6/Picture/0 description: The image is a logo for Abutment. The logo is blue and white. The word "Abutment" is written in white letters on a blue background. Below the word "Abutment" is a blue image that looks like a screw.

Design Limitation for TruAbutment DS

Design parameter	Design Limit
Minimum and Maximum abutment angle	0~25°
Minimum and Maximum Cuff Height	0.5~6.0mm
Minimum and Maximum diameter at theabutment/implant interface	Ø3.8mm~Ø8.0mm
Minimum Thickness	0.4 mm
Minimum and Maximum length ofabutment post (length above the abutmentcollar/gingival height)	4~7 mm

TruBase S

TruBase 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 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 (Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro: X-small, Large and Dentium Company Limited Implantium: Regular and PrimaConnex™ Internal Connection Implant System: 3.5, 4.1, 5.0 and Straumann Ø2.9 mm Bone Level Tapered Implants: Small Crossfit (SC) and Straumann® Bone Level Tapered Implants: Narrow Crossfit (NC), Regular Crossfit (RC) and Xpeed AnyRidge Internal Implant System: 4.0, 4.4, 4.9, 5.4, 5.9 (3.5).

CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the 3Shape Abutment Designer Software, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

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

The TruBase is a device that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

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

TruAbutment Platform Diameter /Compatible Implant System	TruBaseEngaging	TruBaseNon-Engaging
Astra Tech OsseoSpeed (K101732, K024111)
X-small	o	o
Small	o	o
Large	o	o
Dentium SuperLine (K041368)
Regular	o	o

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Image /page/7/Picture/0 description: The image shows a logo for "Abutment.ru". The logo is in blue and features the word "Abutment" in a stylized font. Below the word "Abutment" is the ".ru" domain name, also in blue. The logo has a screw-like design on the left side of the ".ru" domain name.

TruAbutment Platform Diameter /Compatible Implant System	TruBaseEngaging	TruBaseNon-Engaging
Keystone PrimaConnex (K051614)
3.5 (SD)	o	o
4.1 (RD)	o	o
5.0 (WD)	o	o
Straumann Bone Level (K162890) (K140878)
SC	o	o
NC	o	o
RC	o	o
Megagen AnyRidge (K140091)
3.5	o	o

Raw material blanks

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

Cement

. RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.

Software

3Shape Abutment Designer Software by 3Shape A/S, cleared under K151455. ●

Instruments

Screwdrivers (class I exempt devices) ●
. Scanbodies (class I – exempt devices)

Design Limitation for Zirconia superstructure

Design parameter	Design Limit
Minimum and Maximum abutment angle	0~15°
Minimum and Maximum Cuff Height	0.5~5 mm
Minimum and Maximum diameter at theabutment/implant interface	$\varnothing$ 5.0mm~ $\varnothing$ 8.0mm
Minimum Thickness	0.4 mm
Minimum and Maximum length ofabutment post (length above the abutmentcollar/gingival height)	4~6 mm

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Image /page/8/Picture/0 description: The image shows a logo for "Abutment.ru". The logo is in blue and features the word "Abutment" in a sans-serif font, with the "A" slightly larger than the other letters. Below the word "Abutment" is the text ".ru" in a larger, stylized font. To the left of the text is a graphic that resembles a screw or bolt.

Indication for Use

TruAbutment DS

· Astra Tech Implant System (K101732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)
· Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular)
· PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)
· Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890): 2.9 (SC)
· Straumann® Bone Level Tapered Implants (K140878): 3.3, 4.1, 4.8 (NC, RC)

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase

TruBase 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 a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

· Astra Tech Implant System (K101732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)
· Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular)
· PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)
· Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890): 2.9 (SC)
· Straumann® Bone Level Tapered Implants (K140878): 3.3, 4.1, 4.8 (NC, RC)
· Xpeed AnyRidge Internal Implant System (K140091): 4.0, 4.4, 4.9, 5.4, 5.9 (3.5)

All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.

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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 stylized font, also in blue. The left side of the logo has a jagged edge, resembling the threads of a screw.

TruAbutment DS and TruBase are compatible with the following devices:

ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-Abutment Connection
Astra TechOsseoSpeedTX(K101732)(K024111)	3.0 S	11	24982	3.0(X-small)	Image: Internal double hexagon.
		13	24983
		15	24984
	3.5 S	8	24930	3.5/4.0(Small)
		9	24931
		11	24932
		13	24933
		15	24934
	4.0 S	17	24935	4.5/5.0(Large)
		8	24930
		9	24931
		11	24932
		13	24933
	4.5	15	24934
		17	24935
		9	24951
		11	24952
	13	24953
	15	24954
	17	24955
5.0	9	24961	4.5/5.0(Large)
	11	24962
	13	24963
	15	24964
	17	24965
5.0 S	2	24971
	11	24972
	13	24973
	15	24974
	17	24975
DentiumSuperLine(K041368)	3.4	8	FX3608SWC	Regular
		10	FX3610SWC
		12	FX3612SWC
		14	FX3614SWC
	3.8	8	FX4008SWC
		10	FX4010SWC
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-Abutment Connection
	4.3	12	FX4012SWC		Internal Hex
		14	FX4014SWC
		8	FX4508SWC
		10	FX4510SWC
		12	FX4512SWC
		14	FX4514SWC
	4.8	8	FX5008SWC
		10	FX5010SWC
		12	FX5012SWC
		14	FX5014SWC
		8	FX6008SWC
		10	FX6010SWC
	4.8	12	FX6012SWC
	3.5	10	15413K	3.5(SD)	Internal TiLobe
		11.5	15414K
		13	15415K
		15	15416K
KeystonePrimaConnex(K051614)	4.1	10	15417K	4.1(RD)
		11.5	15418K
		13	15419K
		15	15415K
	5.0	10	15421K	5.0(WD)
		11.5	15422K
		13	15423K
		15	15424K
StraumannBone LevelTaperedImplantsSC(K162890)	2.9	10	021.0010	SmallCrossfit(SC)	Internal Cross Fit®
		12	021.0112
		14	021.0114
StraumannBone LevelTaperedImplantsNC, RC(K140878)	3.3	8	021.3508	NarrowCrossfit(NC)
		10	021.3510
		12	021.3512
		14	021.3514
		16	021.3516
		18	021.3518
	4.1	8	021.5508
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-Abutment Connection
MegagenAnyRidge®(K140091)	4.8	10	021.5510	RegularCrossfit(RC)
		12	021.5512
		14	021.5514
		16	021.5516
		18	021.5518
		8	021.7508
		10	021.7510
		12	021.7512
		14	021.7514
		16	021.7516
		18	021.7518
		7	FANIHX3507C
4.0	8	FANIHX3508C	3.5	Image: Internal Hex
	10	FANIHX3510C
	11.5	FANIHX3511C
	13	FANIHX3513C
	15	FANIHX3515C
	7	FANIHX4007C
4.4	8	FANIHX4008C
	10	FANIHX4010C
	11.5	FANIHX4011C
	13	FANIHX4013C
	15	FANIHX4015C
	7	FANIHX4508C
4.9	8	FANIHX4508C
	10	FANIHX4510C
	11.5	FANIHX4511C
	13	FANIHX4513C
	15	FANIHX4515C
	7	FANIHX5007C
5.4	8	FANIHX5008C
	10	FANIHX5010C
	11.5	FANIHX5011C
	13	FANIHX5013C
	15	FANIHX5015C
	7	FANIHX5507C
5.9	8	FANIHX5508C
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-Abutment Connection
		10	FANIHX5510C
		11.5	FANIHX5511C
		13	FANIHX5513C
		15	FANIHX5515C

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Image /page/10/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The letter "A" is larger than the other letters, and the letters "ru" are connected and larger than the rest of the word.

TruAbutment Inc. 17742 Cowan, Irvine, CA 92614

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Image /page/11/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The letter "A" is larger than the other letters, and the letters "ru" are connected and stylized to look like a single shape.

TruAbutment Inc. 17742 Cowan, Irvine, CA 92614

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Image /page/12/Picture/0 description: The image shows a logo for a company called "ABUTMENT". The logo is blue and white, with the word "ABUTMENT" in a stylized font. The letter "A" is larger than the other letters, and the letters "ru" are connected and stylized to look like a screw. The logo is simple and modern, and it is likely used to represent a company that specializes in dental implants or other dental products.

TruAbutment Inc. 17742 Cowan, Irvine, CA 92614

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Image /page/13/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 head, also in blue. The overall design is simple and modern.

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 individual diameter and connection type. Comparison demonstrating Substantial Equivalence follows at the end of this section.

TruAbutment DS

Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K201197)
Indications for Use	TruAbutment DS is a patient-specific CAD/CAMabutment, directly connected to endosseous dentalimplants and is intended for use as an aid in prostheticrehabilitation. It is compatible with the followingsystems:	TruAbutment DS is a patient-specific CAD/CAMabutment, directly connected to endosseous dentalimplants and is intended for use as an aid in prostheticrehabilitation. It is compatible with the following systems:
	Astra Tech Implant System (K101732), Astra Tech OsseoSpeed,Astra Tech Fixture MicroMacro (New Indication) (K024111):3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)	Zimmer 3.1mmD Dental Implant System (K142082)Screw Vent® and Tapered Screw Vent® (K013227)Nobel Active 3.0 (K102436)Nobel Active Internal Connection Implant (K071370)
	Dentium Company Limited Implantium (K041368): 3.4, 3.8,4.3, 4.8 (Regular)	All digitally designed abutments and/or coping for usewith the TruAbutment DS abutments are intended to besent to a TruAbutment-validated milling center formanufacture.
	PrimaConnex™ Internal Connection ImplantSystem(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)	TruAbutment DS is compatible with the followingdevices:Zimmer 3.1mmD Dental Implant System(K142082)Implant Body Diameter 3.1/ Implant Platform Diameter2.9 / Internal HexScrew Vent® and Tapered Screw Vent® (K013227)
	Straumann Ø2.9 mm Bone Level Tapered Implants, SCCARES Abutments (K162890): 2.9 (SC)
	Straumann® Bone Level Tapered Implants (K140878): 3.3,4.1, 4.8 (NC, RC)
	All digitally designed abutments and/or coping for usewith the TruAbutment DS abutments are intended to besent to a TruAbutment-validated milling center for
	manufacture.
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K201197)
		Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex
		Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex
		Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex
		Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex
		Nobel Active 3.0 (K102436)Implant Body Diameter 3.0/ Implant Platform Diameter 3.0/ Internal Hex
		Nobel Active Internal Connection Implant (K071370)Implant Body Diameter 3.5/ Implant Platform Diameter NP / Internal Hex
		Implant Body Diameter 4.3/ Implant Platform Diameter RP / Internal Hex
		Implant Body Diameter 5.0/ Implant Platform Diameter RP / Internal Hex
		Implant Body Diameter 5.5/ Implant Platform Diameter WP / Internal Hex
CAD Design Limits	Minimum and Maximum abutment angle: 0~~25°Minimum and Maximum Gingival (Cuff) Height: 0.5~~6.0mmMinimum and Maximum diameter at abutment/implant interface:$Ø3.8~~Ø8.0$Minimum and Maximum length of abutment: 6~~11mmMinimum wall thickness at the abutment/implant interface: 0.4mmMinimum and Maximum length of abutment post (length above the abutment collar/gingival height): 4~8mm	Minimum and Maximum abutment angle: 0~~25°Minimum and Maximum Gingival (Cuff) Height: 0.5~~4.0mmMinimum and Maximum diameter at abutment/implant interface:$Ø3.8~~Ø5.5$Minimum and Maximum length of abutment: 6~~11mmMinimum wall thickness at the abutment/implant interface: 0.4mmMinimum and Maximum length of abutment post (length above the abutment collar/gingival height): 4~7mm
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K201197)
Connection	Internal Connections	Internal Connections
Sterility	Packaged Non-sterile	Packaged Non-sterile
Material	Ti-6AI-4V ELI	Ti-6AI-4V ELI
Abutment Seat	Sits on Taper	Sits on Taper
Anatomical Site	Oral Cavity	Oral Cavity
Construction	Machined	Machined
Type of Retention	Screw-retained to the implant. The prosthesis can be cement-retained to the abutment.	Screw-retained to the implant. The prosthesis can be cement-retained to the abutment.

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Image /page/14/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The word is written in all capital letters and is in a blue color. The letter "A" is larger than the other letters and has a jagged edge on the left side.

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Image /page/15/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The "A" in "ABUTMENT" is larger than the other letters. Below the word "ABUTMENT" is a graphic that resembles a tooth implant. The logo is in a light blue color.

TruBase

Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruBase	TruBase S (K201197)
Indications for Use	TruBase is a titanium component that is directly connectedto endosseous dental implants to provide support forpatient-specific prosthetic restorations, such as copings orcrowns. It is indicated for screw-retained single tooth orcement-retained single tooth and bridge restorations. It iscompatible with the following systems:Astra Tech Implant System (K101732), Astra Tech OsseoSpeed,Astra Tech Fixture MicroMacro (New Indication) (K024111):3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)Dentium Company Limited Implantium (K041368): 3.4, 3.8,	TruBase S is a titanium component that is directlyconnected to endosseous dental implants to providesupport for custom prosthetic restorations, such ascopings or crowns. It is indicated for screw-retainedsingle tooth or cement-retained single tooth and bridgerestorations. It is compatible with the following systems:Zimmer 3.1mmD Dental Implant System (K142082)Screw Vent® and Tapered Screw Vent® (K013227)TruBase S is intended to be sent to a TruAbutment-
	4.3, 4.8 (Regular)	validated milling center for manufacture.
	PrimaConnex™ Internal Connection ImplantSystem(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)	TruBase S is compatible with the following devices:
	Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARESAbutments (K162890): 2.9 (SC)	Zimmer 3.1mmD Dental Implant System(K142082)Implant Body Diameter 3.1/ Implant Platform Diameter2.9 / Internal Hex
	Straumann® Bone Level Tapered Implants (K140878): 3.3, 4.1,4.8 (NC, RC)Xpeed AnyRidge Internal Implant System (K140091): 4.0, 4.4,4.9, 5.4, 5.9 (3.5)	Screw Vent® and Tapered Screw Vent® (K013227)Implant Body Diameter 3.7/ Implant Platform Diameter3.5 / Internal HexImplant Body Diameter 4.1/ Implant Platform Diameter3.5 / Internal Hex
	All digitally designed zirconia superstructure for usewith the TruBase are intended to be sent to aTruAbutment-validated milling center formanufacture.	Implant Body Diameter 4.7/ Implant Platform Diameter4.5 / Internal HexImplant Body Diameter 6.0/ Implant Platform Diameter5.7 / Internal Hex
CAD Design Limits	Maximum Angulation 0~~15°Maximum Cuff Height 0.5~~5mmMinimum Diameter Ø5.0~ Ø8.0mmMinimum Thickness 0.4mmMinimum Post Height 4~6mm	Maximum Angulation 0~~15°Maximum Cuff Height 0.5~~5mmMinimum Diameter Ø5.0~ Ø8.0mmMinimum Thickness 0.4mmMinimum Post Height 4~6mm
Material ofAbutment	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Implant-to-AbutmentConnection(s)	Screw-retained to the implant. The prosthesis can be cement-retained to the abutment.	Screw-retained to the implant. The prosthesis can be cement-retained to the abutment.
Type of Retention	Screw-retained.	Screw-retained

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Image /page/16/Picture/0 description: The image features the word "ABUTMENT" in a stylized, sans-serif font. The letter "A" is larger and bolder than the rest of the word. Below "ABUTMENT" is a design that resembles a screw or a gear, with a series of teeth or ridges. The color of the text and design is a bright, light blue.

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Image /page/17/Picture/0 description: The image features the word "ABUTMENT" in a stylized, sans-serif font. The letter "A" is larger and bolder than the rest of the word. Below "ABUTMENT" is a design that resembles a screw or a gear, with a series of teeth or ridges. The color of the text and design is a bright, light blue.

Material ofSuperstructure	InCoris Zi (K123664)	InCoris ZI (K123664)
Patient-SpecificDesign	CAD/CAM manufactured superstructures	CAD/CAM manufactured superstructures
End-UserSterilization	Moist steam sterilization	Moist steam sterilization

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Image /page/18/Picture/0 description: The image is a logo for "Abutment.ru". The logo is in blue and features the word "Abutment" in a sans-serif font, with the "A" slightly larger than the other letters. Below "Abutment" is the text ".ru" in a stylized, cursive font. To the left of the text is a graphic that resembles a tooth implant.

Substantial Equivalence Discussion

The subject device (TruAbutment DS) 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, the primary predicate device, and the reference devices.

The Indications for Use Statement (IFUS) for the subject device (TruAbutment DS) 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.

Slight differences in the language of the subject device (TruAbutment DS) and primary predicate (K201197). 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 minor differences between the subject device (TruAbutment DS) and the primary predicate device (K201197) are related to the compatible OEM implant lines and the implant platform diameter.

The difference between the two products (TruAbutment DS, K201197) in the design parameters are the same except for the minimum diameter. The minimum diameter of the product compatible with the subject device is larger than the Primary predicate device (K201197). The diameter of the primary predicate device (K201197) is Ø3.5mm ~ Ø8.0mm, while the subject device (TruAbutment DS) can be designed up Ø3.8mm~Ø8.0mm. The minor differences between the subject device (TruAbutment DS) and the primary predicate device (K201197) are related to the compatible OEM implant lines and the implant platform diameter.

Design parameter	Subject Device(TruAbutment DS)Design Limit	Primary Predicate Device(K201197)Design Limit
Minimum and Maximum abutmentangle	0~25°	0~25°
Minimum and Maximum Gingival(Cuff) Height	0.5~6.0mm	0.5~6.0mm
Minimum and Maximum diameterat the abutment/implant interface	⌀3.8mm~⌀8.0mm	⌀3.5mm~⌀8.0mm
Minimum and Maximum length ofthe abutment	6~11mm	6~11mm
Minimum wall thickness atabutment/implant interface	0.4 mm	0.4 mm
Minimum and Maximum length ofabutment post (length above theabutment collar/gingival height)	4~7mm	4~7mm

The following subject device (TruBase) is substantially equivalent in indications and design principles to the primary predicate device(K201197). The subject device (TruBase) and the primary predicate device(K201197) have internal implant interface connections, and are made of Ti-6Al-4V (abutments and abutment screws).

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Image /page/19/Picture/1 description: The image is a logo for Abutment. The logo is blue and features the word "Abutment" in a stylized font. The "A" in Abutment is larger than the other letters and has a jagged edge, resembling a screw. The rest of the word is in a smaller, sans-serif font.

The subject devices (TruAbutment DS, TruBase) are to be sterilized by the end-user, the same as primary predicate devices (K201197).

Sterilization validation for the subject devices (TruAbutment DS, TruBase) was performed according to ISO 17665-1 and ISO 17665-2. This sterilization validation method is the same as the primary predicate devices (K201197).

Mechanical performance testing was performed according to ISO 14801. For compatible OEM implant line, worst-case constructs were subjected to static compression and 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 the predicate device (K152559, K170259) 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.

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.

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: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems.

Conclusion

The TruAbutment DS, TruBase 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. TruAbutment DS, TruBase, 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.)