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:

· MIS C1 Conical Connection Implant (K172505, K112162)
: 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
· Neodent Implant System GM Helix (K163194, K180536)
: 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
· Nobel Biocare Groovy Implants (K050258)
: 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
· Straumann BLX Implant (K173961, K181703, K191256)
: 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
· Straumann Tissue Level Implant (K111357)
: 3.3(NNC)

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 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:

· MIS C1 Conical Connection Implant (K172505, K112162)
: 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
· Neodent Implant System GM Helix (K163194, K180536)
: 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
· Nobel Biocare Groovy Implants (K050258)
: 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
· Straumann BLX Implant (K173961, K181703, K191256)
: 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
· Straumann Tissue Level Implant (K111357)
: 3.3(NNC)

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

Device Description

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patientspecific 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. The system also includes a TruBase screw for fixation to the implant body.

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. The TruBase screws are composed of titanium alloy per ASTM F136.

CAD/CAM customized superstructure that composes the final abutment is 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 in the lab.

AI/ML Overview

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices, which are endosseous dental implant abutments. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed "acceptance criteria" and results from a study proving the device meets those specific criteria in the way one might find for a novel AI/software medical device.

The document discusses performance in terms of mechanical resistance and dimensional compatibility to ensure long-term functional performance with dental implants. However, it does not outline distinct "acceptance criteria" that are then verified by a specific study with a defined sample size, ground truth, or expert adjudication as typically seen in AI/ML validation. Instead, it relies on demonstrating compliance with recognized standards and comparability to a predicate device.

Given the information provided, here's an attempt to answer the questions based on the context of this 510(k) summary, interpreting "acceptance criteria" as the performance expectations set by the applicable standards and "study" as the non-clinical testing performed:

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

The document doesn't explicitly state "acceptance criteria" in a tabular format with corresponding reported performance for a comparative AI study. Instead, it refers to compliance with established standards for dental implant abutments. The closest equivalent to "acceptance criteria" for the mechanical performance is meeting the requirements of ISO 14801.

Acceptance Criteria (Derived from Standards/Comparisons)	Reported Device Performance
Mechanical Performance: Fatigue limit based on ISO 14801:2016 for worst-case constructs of compatible OEM implant lines.	"The fatigue limit data for all other implant lines demonstrated the construct strengths to be sufficient for their intended use." (Implies compliance with ISO 14801, i.e., meeting or exceeding the minimum required fatigue strength as per the standard).
Dimensional Compatibility: 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"
Sterilization: Compliance with ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.	"Sterilization validation for the subject devices (TruAbutment DS, TruBase) was performed according to ISO 17665-1 and ISO 17665-2. This sterilization method is the same as the primary predicate devices (K202579)."
Biocompatibility: Compliance with ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.	"Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. The results of the above tests have met the criteria of the standard..."

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

The document does not specify a "test set" sample size in the context of an AI/ML model for image analysis or diagnostics. The testing described is primarily non-clinical mechanical testing, dimensional analysis, and biocompatibility testing of physical devices.

Sample Size: Not specified in terms of "number of cases" or "patients" for a diagnostic study. For mechanical testing, samples would be physical devices/constructs. The number of samples for ISO 14801 fatigue testing is typically defined by the standard itself (e.g., typically 3 samples for static and 15 samples for fatigue for each configuration).
Data Provenance: Not applicable in the sense of patient data or images. The "data" comes from physical testing of manufactured devices.

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

This information is not applicable to the type of device and testing described. The "ground truth" for mechanical properties is established by physical measurement against engineering specifications and performance under defined load conditions, not by expert human interpretation.

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

Not applicable. There is no human interpretation or subjective assessment involved that would require an adjudication method.

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. The device is a physical dental implant abutment, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a physical dental implant abutment, not an AI algorithm.

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

The "ground truth" for this medical device is based on engineering specifications, material science standards (e.g., ASTM F136), and mechanical testing standards (e.g., ISO 14801). For example, mechanical strength and fatigue life are measured directly, and dimensional compatibility is assessed against design tolerances.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set. The "design" of the abutments is based on CAD/CAM systems informed by engineering principles, not machine learning from large datasets.

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

Not applicable. As this is not an AI/ML device, there is no "training set" or "ground truth for the training set" in the context of machine learning. The knowledge base for the CAD/CAM design and manufacturing is derived from established dental and engineering principles, material science, and regulatory standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). The logo includes the Department of Health & Human Services seal on the left. To the right of the seal is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 15, 2021

TruAbutment Inc. Chris Choi Director 17666 Fitch Irvine, California 92614

Re: K203649

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: March 26, 2021 Received: August 16, 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 and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203649

Device Name TruAbutment DS, TruBase

Indications for Use (Describe)

TruAbutment DS

· MIS C1 Conical Connection Implant (K172505, K112162)
: 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
· Neodent Implant System GM Helix (K163194, K180536)
: 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
· Nobel Biocare Groovy Implants (K050258)
: 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
· Straumann BLX Implant (K173961, K181703, K191256)
: 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
· Straumann Tissue Level Implant (K111357)
: 3.3(NNC)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Indications for Use

510(k) Number (if known) K203649

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:

· MIS C1 Conical Connection Implant (K172505, K112162)
: 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
· Neodent Implant System GM Helix (K163194, K180536)
: 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
· Nobel Biocare Groovy Implants (K050258)
: 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
· Straumann BLX Implant (K173961, K181703, K191256)
: 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
· Straumann Tissue Level Implant (K111357)
: 3.3(NNC)

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

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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 a company called "Abutment ru". The logo is blue and features the word "Abutment" in a large, bold font. Below the word "Abutment" is the letters "ru" in a similar font. To the left of the word "Abutment" is a graphic of a screw.

510(k) Summary K203649

Submitter	Official Correspondent
TruAbutment Inc.	TruAbutment Inc.
Eunjin Jang	Chris Choi
17666 Fitch,	17666 Fitch,
Irvine, CA 92614	Irvine, CA 92614
USA	USA
Email: eunjin.jang@truabutment.com	Email: chris.choi@truabutment.com
Phone: 1-714-956-1488	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: 09/14/2021

Primary Predicate / Reference Devices:

Primary Predicate:

TruAbutment DS, TruBase (K202579) by TruAbutment Inc. .

Reference Devices:

MIS C1 Narrow Platform Conical Connection Implant System (K172505) by MIS Implants Technologies Ltd.
. MIS C1 Standard, Wide Platform Conical Connection Implants (K112162) by MIS Implants Technologies Ltd.
Neodent Implant System GM Helix (K163194) by Straumann USA, LLC. ●
Neodent Implant System GM Helix (K180536) by PaxMed International, LLC. ●
Nobel Biocare Groovy Implants (K050258) by Nobel Biocare AB.
Straumann BLX Implant System (K173961) by Straumann USA, LLC.
Straumann BLX Line Extension - Implants (K181703) by Straumann USA, LLC.
. Straumann BLX Ø3.5 Mm Implants (K191256) by Straumann USA, LLC.
Straumann Narrow Neck CrossFit (NNC) Ø3.3mm Dental Implant System (K111357) by ● Straumann USA.

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Image /page/5/Picture/0 description: The image shows a logo for a company or organization called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a bold, sans-serif font, stacked above the letters "ru", which are also in blue but in a different, more stylized font. To the left of the "ru" is a design that resembles a gear or cogwheel, also in blue, which adds a mechanical or technical element to the logo.

General Description

TruAbutment DS

(1) For fixing into the endosseous implant

(2) For dental laboratory use during construction of related restoration.

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.

Design Parameter	Design Limit
Minimum and Maximum abutment angle(°)	0 ~ 25
Minimum and Maximum cuff height(mm)	0.5 ~ 6.0
Minimum and Maximum diameter at abutment/implant interface(Ø,mm)	3.8 ~ 8.0
Minimum thickness(mm)	0.4
Minimum and Maximum length of abutment post(length above the abutment collar / gingival height) (mm)	4.0 ~ 7.0

Design Limitation for TruAbutment DS

TruBase

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Image /page/6/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a bold, sans-serif font stacked above the letters "ru", which are also in blue. The "A" in "Abutment" is larger than the other letters, and the left side of the "r" in "ru" is stylized to resemble the threads of a screw or bolt.

Conical Connection Implant (K172505, K112162): 3.3 (NP), 3.75, 4.2, 5.0 (SP,WP), Neodent Implant System - GM Helix (K163194, K180536): 3.5, 3.75, 4.0, 4.3, 5.0 (3.0), Nobel Biocare Groovy Implants (K050258): 3.5.4.3, 5.0, 6.0 (NP, RP, WP, 6.0), Straumann BLX Implant System (K173961, K181703, K191256): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB), Straumann Tissue Level (K111357): 3.3 (NNC). The TruBase screws are composed of titanium alloy per ASTM F136.

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.

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. .
Design Limitation for Zirconia superstructure

Design Parameter	Design Limit
Minimum and Maximum angulation(°)	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, stacked above the letters "ru", which are connected and stylized to resemble a screw or bolt. The overall design is modern and suggests a connection to engineering or construction.

Indication for Use

TruAbutment DS

· MIS C1 Conical Connection Implant (K172505, K112162) : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
· Neodent Implant System GM Helix (K163194, K180536) : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
· Nobel Biocare Groovy Implants (K050258) : 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)
· Straumann BLX Implant (K173961, K181703, K191256) : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
· Straumann Tissue Level Implant (K111357) : 3.3(NNC)

All digitally designed abutments and/or coping for use with the TruAbutment DS abutments 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:

· MIS C1 Conical Connection Implant (K172505, K112162) : 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)
· Neodent Implant System GM Helix (K163194, K180536) : 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
· Nobel Biocare Groovy Implants (K050258)
: 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0) · Straumann BLX Implant (K173961, K181703, K191256)
- : 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
· Straumann Tissue Level Implant (K111357) : 3.3(NNC)

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/8/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a sans-serif font and is placed above the letters "ru", which are in a cursive font. The logo is in a bright blue color. The left side of the "A" in "Abutment" has a jagged edge, resembling a screw.

ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
MIS C1(K172505,K112162)	3.3	10	C1-10330	NarrowPlatform(NP)	Image: Conical connection
	3.3	11.5	C1-11330
	3.3	13	C1-13330
	3.3	16	C1-16330
	3.75	8	C1-08375	StandardPlatform(SP)
MIS C1(K172505,K112162)	3.75	10	C1-10375
MIS C1(K172505,K112162)	3.75	11.5	C1-11375
MIS C1(K172505,K112162)	3.75	13	C1-13375
MIS C1(K172505,K112162)	3.75	16	C1-16375
MIS C1(K172505,K112162)	4.2	8	C1-08420	StandardPlatform(SP)
MIS C1(K172505,K112162)	4.2	10	C1-10420
MIS C1(K172505,K112162)	4.2	11.5	C1-11420
MIS C1(K172505,K112162)	4.2	13	C1-13420
MIS C1(K172505,K112162)	4.2	16	C1-16420	StandardPlatform(SP)
MIS C1(K172505,K112162)	5.0	8	C1-08500
MIS C1(K172505,K112162)	5.0	10	C1-10500
MIS C1(K172505,K112162)	5.0	11.5	C1-11500
MIS C1(K172505,K112162)	5.0	13	C1-13500	WidePlatform(WP)
MIS C1(K172505,K112162)	5.0	16	C1-16500
Neodent GM(K163194,K180536)	3.5	8	109.943		3.0
	3.5	10	109.944
	3.5	11.5	109.945
	3.5	13	109.946
	3.5	16	109.947
	3.5	18	109.988
Neodent GM(K163194,K180536)	3.75	8	109.976	3.0
	3.75	10	109.977
	3.75	11.5	109.978
	3.75	13	109.979
	3.75	16	109.980
	3.75	18	109.981
Neodent GM(K163194,K180536)	4.0	8	109.982	3.0
	4.0	10	109.983
	4.0	11.5	109.984
	4.0	13	109.985
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
	4.3	16	109.986
		18	109.987
		8	109.948
		10	109.949
		11.5	109.950
		13	109.951
		16	109.952
		18	109.989
	5.0	8	109.953
		10	109.954
		11.5	109.955
		13	109.956
		16	109.957
		18	109.990
		8	109.1009
		10	109.1010
		11.5	109.1011
		13	109.1012
	3.5	8	32211	NarrowPlatform(NP)	Image: Internal tri-channel connection
		10	32212
		11.5	36100
		13	32213
		16	32214
Nobel BiocareGroovyImplants(K050258)	4.3	8	32215	RegularPlatform(RP)
		10	32216
		11.5	36101
		13	32217
		16	32218
	5.0	8	32219	WidePlatform(WP)
10		32220
11.5		36102
13		32221
16		32222
	6.0	8	32223	6.0
		10	32224
		11.5	36103
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
		13	32225
		16	32226
			3.5
10	061.3310
12	061.3312
14	061.3314
16	061.3316
18	061.3318
	3.75	6	061.4306
		8	061.4308
		10	061.4310
		12	061.4312
		14	061.4314
		16	061.4316
		18	061.4318	RegularBase(RB)	Image: TorcFit connection
StraumannBLX(K173961,K181703,K191256)	4.0	6	061.5306
		8	061.5308
		10	061.5310
		12	061.5312
		14	061.5314
		16	061.5316
			18	061.5318
	4.5	6	061.6306
		8	061.6308
		10	061.6310
		12	061.6312
		14	061.6314
		16	061.6316
		18	061.6318
	5.0	6	061.7306	Wide Base(WB)
		8	061.7308
		10	061.7310
		12	061.7312
		14	061.7314
		16	061.7316
		18	061.7318
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
	5.5	6	061.8306
		8	061.8308
		10	061.8310
		12	061.8312
	6.5	6	061.9306
		8	061.9308
		10	061.9310
		12	061.9312
StraumannTissue Level(K111357)	3.3	8	033.416S	NarrowNeckCrossfit(NNC)	Image: CrossFit connection
		10	033.417S
		12	033.418S
		14	033.419S

TruAbutment DS and TruBase are compatible with the following OEM devices:

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Image /page/9/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a sans-serif font and is placed above the letters "ru", which are in a cursive font. To the left of the letters "ru" is a graphic of a screw.

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

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Image /page/10/Picture/0 description: The image shows a logo for "Abutment ru". The word "Abutment" is in a sans-serif font, with the "A" being larger than the rest of the letters. The letters "ru" are in a smaller, cursive font and are placed below and to the right of "Abutment". To the left of the "ru" is a graphic of a screw.

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

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Image /page/11/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is blue and features the company name in a stylized font. The "ru" portion of the name is larger and bolder than the "Abutment" portion. The logo also includes a graphic of a screw thread, which is likely related to the company's products or services.

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

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Image /page/12/Picture/0 description: The image is a logo for a company called "Abutmentru". The logo is primarily blue and features the word "ABUTMENT" in a bold, sans-serif font. Below "ABUTMENT" is the letters "ru" in a similar font, but slightly smaller. 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 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 (K202579)
Indications for Use	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:MIS C1 Conical Connection Implant (K172505, K112162): 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)Neodent Implant System - GM Helix (K163194, K180536): 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0(3.0)Nobel Biocare Groovy Implants (K050258): 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)Straumann BLX Implant (K173961, K181703, K191256): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)Straumann Tissue Level Implant (K1113575): 3.3(NNC)All digitally designed abutments and/or coping for use with the TruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.	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 TechOsseoSpeed, Astra Tech Fixture MicroMacro (NewIndication) (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)

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Image /page/13/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is in a bright blue color. The word "Abutment" is written in a sans-serif font, with the "A" being larger than the other letters. Below the word "Abutment" is the letters "ru", also in a sans-serif font. To the left of the letters "ru" is a stylized image of a screw.

Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K202579)
		All digitally designed abutments and/or coping for use withthe TruAbutment DS abutments are intended to be sent to aTruAbutment-validated milling center for manufacture.
CAD Design Limits	Minimum and Maximum abutment angle(°): 0~~25Minimum and Maximum gingival (cuff) height(mm):0.5~~6.0Minimum and Maximum diameter at abutment/implantinterface( $Ø$ ,mm): 3.3~~8.0Minimum and Maximum length of abutment(mm): 6.0~~11.0Minimum wall thickness at the abutment/implantinterface(mm): 0.4~~0.9Minimum and Maximum length of abutment post (lengthabove the abutment collar/gingival height)(mm): 4.0~~7.0	Minimum and Maximum abutment angle: 0~~25°Minimum and Maximum Gingival (Cuff) Height:0.5~~6.0mmMinimum and Maximum diameter at abutment/implantinterface: $Ø$ 3.8~ $Ø$ 8.0Minimum and Maximum length of abutment: 6~~11mmMinimum wall thickness at the abutment/implant interface:0.4mmMinimum and Maximum length of abutment post (lengthabove the abutment collar/gingival height): 4~~7mm
Connection	Internal Connections	Internal Connections
Sterility	Packaged Non-sterile	Packaged Non-sterile
Material	Ti-6Al-4V ELI	Ti-6Al-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 a logo for a company called "Abutment.ru". The word "Abutment" is in a sans-serif font and is placed above the letters "ru", which are in a cursive font. To the left of the "r" in "ru" is a jagged line that resembles the teeth of a gear or saw blade. The entire logo is in a light blue color.

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

TruBase

Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruBase	TruBase (K202579)
Indications for Use	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:	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. It is compatible with the following systems:
	MIS C1 Conical Connection Implant (K172505, K112162): 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)Neodent Implant System - GM Helix (K163194, K180536): 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0(3.0)	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)
	Nobel Biocare Groovy Implants (K050258): 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)	Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular)
	Straumann BLX Implant (K173961, K181703, K191256): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)	PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)
	Straumann Tissue Level Implant (K111357): 3.3(NNC)	Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890): 2.9 (SC)
	All digitally designed zirconia superstructure for use with the TruBase are intended to be sent to a TruAbutment-validated milling center for manufacture.	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 usewith the TruBase are intended to be sent toTruAbutment-validated milling center formanufacture.
CAD Design Limits	Maximum angulation(°): 0~~15Maximum cuff height(mm) 0.5~~5.0Minimum and Maximum diameter at theabutment/implant(Ø,mm): 5.0~~8.0Minimum thickness(mm): 0.4Minimum post height(mm): 4~~6	Maximum Angulation 0~~15°Maximum Cuff Height 0.5~~5mmMinimum Diameter Ø5.0~ Ø8.0mmMinimum Thickness 0.4mmMinimum Post Height 4~6mm
Abutment and ScrewMaterial	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Implant-to-AbutmentConnection(s)	Screw-retained to the implant. The prosthesis can becement-retained to the abutment.	Screw-retained to the implant. The prosthesis can becement-retained to the abutment.
Type of Retention	Screw-retained.	Screw-retained
Material ofSuperstructure	InCoris Zi (K123664)	InCoris ZI (K123664)
Patient-SpecificDesign	CAD/CAM manufactured superstructures	CAD/CAM manufactured superstructures
End-User Sterilization	Moist steam sterilization	Moist steam sterilization

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Image /page/15/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a larger, bold, sans-serif font, stacked on top of the letters "ru", which are also in a bold, sans-serif font. To the left of the letters "ru" is a graphic of a screw.

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Image /page/16/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is primarily blue and features the word "Abutment" in a bold, sans-serif font, stacked above the letters "ru", which are also in a bold, sans-serif font. To the left of the letters "ru" is a stylized image of a screw or bolt, also in blue, which adds a visual element related to construction or engineering.

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. The provided tables are comparing the Indications for Use Statements and the technological characteristics of the subject device, the primary predicate device.

The Indications for Use Statement (IFUS) for the subject device (TruAbutment DS) is substantially equivalent in intended use to the primary predicate device (K202579). 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 (K202579) 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 (K202579) are related to the compatible OEM implant lines and the implant platform diameter.

The following subject device (TruBase) is substantially equivalent in indications and design principles to the primary predicate device(K202579) listed above. The subject device (TruBase) and the primary predicate device(K202579) have internal implant interface connections and are made of Ti-6A1-4V ELI (abutments and abutment screws).

The subject devices (TruAbutment DS, TruBase) are to be sterilized by the end-user, the same as primary predicate devices (K202579).

Sterilization validation for the subject devices (TruAbutment DS, TruBase) was performed according to ISO 17665-1 and ISO 17665-2. This sterilization method is the same as the primary predicate devices (K202579).

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.

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Image /page/17/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, with the "A" being larger than the other letters. Below "Abutment" is "ru" in a cursive font. To the left of the text is a graphic that resembles a screw or implant, further emphasizing the company's focus.

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 reference device (K152559, K200817) 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 devices. Therefore, 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.)