TruAbutment DS is a patient-specific CAD/CAM abutment, which is directly connected to endosseous dental implants and is intended to be used as an aid in prosthetic rehabilitation. It is compatible with the following systems: Astra OsseoSpeed EV (K130999, K120414), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF (II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Osstem TS (K161604), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221), BioHorizons Internal Implant System (K093321, K143022, K071638), MegaGen AnyRidge Internal Implant (K140091). All digitally designed abutments and/or copings 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 a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems: Astra OsseoSpeed EV (K130999), Biomet 3i Full OSSEOTITE Tapered Certain (K130949), DIO UF(II) Internal Submerged (K161987, K170608, K173975), Neoss ProActive® (K083561), Camlog Screw-Line (K083496), Conelog Screw-Line (K113779), Implant Direct Legacy2 (K192221). All digitally designed abutments and/or copings for use with the TruAbutment are intended to be sent to a TruAbutment-validated milling center for manufacture.

Device Description

TruAbutment DS, TruBase and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). TruAbutment DS, TruBase are supplied with two identical screws which are used: (1) For fixing the abutment into the endosseous implant. (2) For dental laboratory use during construction of related restoration. TruAbutment DS, TruBase are provided non-sterile. Therefore, it must be sterilized before use. TruAbutment DS, TruBase are devices that can only be sold, distributed, or used upon the order of an authorized healthcare provider, generally referred to as prescription (Rx) devices.

TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for the prosthetic restoration. The subject abutments are indicated for serew-retained restorations. 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.

TruBase is a two-piece abutment. The base component is premanufactured and is used to support a cemented CAD/CAM zirconia superstructure. The base and the zirconia superstructure together form the final abutment. 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. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

AI/ML Overview

The provided text is a 510(k) summary for the TruAbutment DS and TruBase devices. It primarily focuses on demonstrating substantial equivalence to a predicate device (TruAbutment DS, K203649) and does not detail an acceptance criteria table with reported device performance in the manner of a clinical study. The text describes non-clinical testing performed, but not a study designed to prove the device meets acceptance criteria related to a specific clinical outcome or diagnostic accuracy.

Therefore, many of the requested items (acceptance criteria table, sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, type of ground truth) are not applicable based on the content of this 510(k) summary, which is a premarket notification for a medical device primarily based on demonstrating substantial equivalence through engineering and mechanical testing, not clinical performance or AI algorithm validation studies.

However, I can extract the information provided regarding non-clinical testing for the devices.

Acceptance Criteria and Study for TruAbutment DS & TruBase

Based on the provided 510(k) summary, the "acceptance criteria" and "study" described are focused on non-clinical mechanical performance testing and demonstration of substantial equivalence to a predicate device, rather than a clinical study proving performance against specific clinical or diagnostic accuracy metrics with human or AI components.

Here's the relevant information extracted and presented based on the document:

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

The document does not provide a table with specific quantitative acceptance criteria alongside actual reported numerical performance results for the new devices in the context of a comparative study proving their performance against such criteria. Instead, it states that "The results of the above tests have met the criteria of the standard and demonstrated substantial equivalence with the reference devices." This implies a qualitative "met standard" outcome rather than specific numerical performance data.

The tables provided describe the design limits of the devices and compare them to the predicate device, not performance data from a test:

TruAbutment DS Design Parameters (Acceptance Criteria are implied by meeting these limits)

Design Parameter	Subject Device (TruAbutment DS) Design Limit	Primary Predicate Device (K203649) Design Limit	Reported Device Performance (Implied)
Minimum and Maximum abutment angle (°)	0 ~ 25	0 ~ 25	Met specified range
Minimum and Maximum cuff height (mm)	0.5 ~ 6.0	0.5 ~ 6.0	Met specified range
Minimum and Maximum diameter at abutment/implant interface (Ø, mm)	3.3 ~ 8.0	3.3 ~ 8.0	Met specified range
Minimum and Maximum length of the abutment (mm)	6 ~ 11	6 ~ 11	Met specified range
Minimum wall thickness at abutment/implant interface (mm)	0.4	0.4 ~ 0.9	Met specified range
Minimum and Maximum length of abutment post (length above the abutment collar / gingival height) (mm)	4.0 ~ 7.0	4.0 ~ 7.0	Met specified range

TruBase Design Parameters (Acceptance Criteria are implied by meeting these limits)

Design Parameter	Subject Device (TruBase) Design Limit	Primary Predicate Device (K203649) Design Limit	Reported Device Performance (Implied)
Minimum and Maximum angulation (°)	0 ~ 15	0 ~ 15	Met specified range
Minimum and Maximum gingival (cuff) height (mm)	0.5 ~ 5.0	0.5 ~ 5.0	Met specified range
Minimum and Maximum diameter at abutment/implant interface (Ø, mm)	5.0 ~ 8.0	5.0 ~ 8.0	Met specified range
Minimum thickness (mm)	0.4	0.4	Met specified value
Minimum and Maximum length of abutment post (length above the abutment collar / gingival height) (mm)	4.0 ~ 6.0	4.0 ~ 6.0	Met specified range

For mechanical performance, the document states:
"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."

This confirms that the acceptance criteria for mechanical performance were "sufficient for their intended use" as defined by ISO 14801 and worst-case testing, but quantitative results are not provided.

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

Sample Size for Test Set: The document mentions "worst-case constructs" were tested for mechanical performance, and "the entire system including all variations (all compatible implant bodies, dental abutments, and fixation screws)" was evaluated for MRI environment conditions. However, specific numerical sample sizes for these tests are not provided.
Data Provenance: The data comes from non-clinical laboratory testing following international standards (ISO 14801, ISO 17665-1/2, ISO 10993 series). The country of origin and retrospective/prospective nature are not applicable as it's not a clinical data study.

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 is not applicable. The "ground truth" for this type of device (dental abutments) is established through adherence to engineering design specifications, material standards (ASTM F136), and performance under mechanical stress tests (ISO 14801), as well as compliance with sterilization and biocompatibility standards. It does not involve expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

This is not applicable as there is no human interpretation or subjective assessment of data requiring adjudication. Testing is based on objective measurements against engineering standards.

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 is not applicable. The device is an endosseous dental implant abutment, not an AI diagnostic tool.

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

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

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

The "ground truth" for validating these devices is adherence to engineering specifications, material properties, and performance standards (e.g., passing specific load-bearing and fatigue tests per ISO 14801, meeting biocompatibility requirements, maintaining dimensional accuracy). "Dimensional analysis and reverse engineering" were used to confirm compatibility.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning algorithm.

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

This is not applicable for the reason above.

Summary of the Study Proving Device Meets Criteria (Based on Provided Text):

The "study" conducted was primarily non-clinical laboratory testing to demonstrate the mechanical performance, sterilization efficacy, and biocompatibility of the TruAbutment DS and TruBase devices. The objective was to show substantial equivalence to an existing legally marketed device (TruAbutment DS, K203649) by proving that the new devices meet established design limits and performance standards relevant to dental implant abutments.

Mechanical Testing: Performed on "worst-case constructs" according to ISO 14801 for static compression and compression fatigue. The outcome was that "construct strengths [were] sufficient for their intended use."
Sterilization Testing: Performed per ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
Biocompatibility Testing: Performed per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
MRI Environment Evaluation: A non-clinical worst-case MRI review was done using scientific rationale and published literature to assess magnetically induced displacement force and torque.
Dimensional Analysis and Reverse Engineering: Conducted on the implant-to-abutment connection platform to assess critical design aspects and tolerances, confirming compatibility.

The overall conclusion was that the devices "met the criteria of the standard and demonstrated substantial equivalence with the reference devices," thus indicating they met their implied acceptance criteria for safety and performance as medical devices. Clinical testing was explicitly stated as "not necessary."

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA part of the logo is in blue.

October 9, 2024

TruAbutment Inc. Ki Yoon Nam RA Senior Manager 17666 Fitch Irvine, California 92614

Re: K241485

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: September 12, 2024 Received: September 12, 2024

Dear Ki Yoon Nam:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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 -S

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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241485

Device Name

TruAbutment DS; TruBase

Indications for Use (Describe)

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TruAbutment DS

· Astra OsseoSpeed EV (K130999, K120414)

: 3.0, 3.6, 4.2, 4.8, 5.4 mm.
· Biomet 3i Full OSSEOTITE Tapered Certain (K130949)
: 3.25, 4.0, 5.0, 6.0 mm.
· DIO UF (II) Internal Submerged (K161987, K170608, K173975)

: 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (Narrow, Regular) mm.

· Neoss ProActive® (K083561)
: 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm.
· Osstem TS (K161604)
: 3.0, 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) mm.
· Camlog Screw-Line (K083496)
: 3.3, 3.8, 4.3, 5.0, 6.0 mm.
· Conelog Screw-Line (K113779)
: 3.3, 3.8, 4.3, 5.0 mm.
· Implant Direct Legacy2 (K192221)
: 3.2 mm.
· BioHorizons Internal Implant System (K093321, K143022, K071638)
: 3.0, 3.4, 3.8, 4.6, 5.8 mm.
· MegaGen AnyRidge Internal Implant (K140091)
: 3.5, 4.0, 4.5, 5.0, 5.5 (3.5) mm.

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

TruBase

· Astra OsseoSpeed EV (K130999): 3.0 mm.
· Biomet 3i Full OSSEOTITE Tapered Certain (K130949): 3.25, 4.0, 5.0, 6.0 mm.
· DIO UF(II) Internal Submerged (K161987, K170608, K173975): 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (Narrow, Regular) mm.
· Neoss ProActive® (K083561): 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm.
· Camlog Screw-Line (K083496); 3.3. 3.8. 4.3. 5.0. 6.0 mm.
· Conelog Screw-Line (K113779): 3.3, 3.8, 4.3, 5.0 mm.
· Implant Direct Legacy2 (K192221): 3.2 mm.

All digitally designed abutments and/or copings for use with the TruAbutment 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.

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Image /page/6/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is in blue and features the word "Abutment" in a 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 word "ru" is a graphic that resembles the threads of a screw or bolt, which may be a visual representation of the word "abutment".

510(k) Summary K241485

Submitter	Official Correspondent
TruAbutment Inc.	TruAbutment Inc.
Rawa Abukhalaf	Ki Yoon Nam
17666 Fitch,	17666 Fitch,
Irvine, CA 92614 USA	Irvine, CA 92614 USA
Email: rawa.abukhalaf@truabutment.com	Email: kiyoon.nam@truabutment.com
Phone: 1-714-956-1488	Phone: 1-714-956-1488

Device Information

. Trade Name: TruAbutment DS, TruBase
Common Name: Abutment, Implant, Dental, Endosseous
Classification Name: Endosseous dental implant abutment
Product Code: NHA
Panel: Dental
Regulation Number: 21 CFR 872.3630
Device Class: Class II
Date prepared: 10/09/2024. ●

Primary Predicate / Reference Devices:

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

Primary Predicate:

. TruAbutment DS (K203649) by TruAbutment Inc.

Reference Devices for OEM Compatibilities:

Astra OsseoSpeed EV (K130999, K120414) by Astra Tech, Inc. ●
Biomet 3i Full OSSEOTITE Tapered Certain (K130949) by Zimmer Biomet. ●
DIO UF (II) Internal Submerged (K161987, K170608, K173975) by DIO Implant Co., Ltd. ●
Neoss ProActive® (K083561) by Neoss Limited. ●
Camlog Screw-Line (K083496) by CAMLOG Biotechnologies GmbH. .
Conelog Screw-Line (K113779) by CAMLOG Biotechnologies GmbH.
Osstem TS Fixture System (K161604) by Osstem Implant Co., Ltd. ●
BioHorizons Laser-Lok 3.0 Implant System (K093321) by Biohorizons Implant Systems, Inc. .

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Image /page/7/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 in a smaller, cursive font. To the left of the text, there is a stylized image of a screw, also in blue, which appears to be part of the "A" in "Abutment".

Biohorizons Tapered Internal Implant System (K143022) by Biohorizons Implant Systems, Inc. .
Biohorizons Tapered Internal Implant System (K071638) by Biohorizons Implant Systems, Inc. ●
. Xpeed AnyRidge Internal Implant System (K140091) by MegaGen Implant Co., Ltd.
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, . Legacy4 fixture-mounts (K192221) by Implant Direct LLC.

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Image /page/8/Picture/0 description: The image is 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 larger, bolder sans-serif font. To the left of the letters "ru" is a graphic of a screw. The entire logo is in a light blue color.

General Description

TruAbutment DS, TruBase and abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F136). TruAbutment DS, TruBase are supplied with two identical screws which are used:

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

TruAbutment DS, TruBase are provided non-sterile. Therefore, it must be sterilized before use.

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

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

TruAbutment PlatformDiameter / CompatibleImplant System	TruAbutment DSEngaging	TruAbutmentDSNon-Engaging	TruBaseEngaging	TruBaseNon-Engaging
Astra OsseoSpeed EV
3.0	X	0	0	0
3.6	X	0	X	X
4.2	X	0	X	X
4.8	X	0	X	X
5.4	X	0	X	X
Biomet 3i FullOSSEOTITE TaperedCertain
3.4	X	0	0	0
4.1	X	0	0	0
5.0	X	0	0	0
6.0	X	0	0	0
DIO UF (II) Internal
Narrow	X	0	0	0
Regular	X	0	0	0
Neoss ProActive®
NP	X	0	0	0
SP	X	0	0	0
Camlog Screw-Line
3.3	0	0	0	0
3.8	0	0	0	0

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Image /page/9/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 above the letters "ru". To the left of the letters "ru" is a graphic that resembles the side view of a screw or bolt, also in blue. The overall design is simple and modern, with a focus on the company's name and a visual element related to engineering or construction.

4.3	0	0	0	0
5.0	0	0	0	0
6.0	0	0	0	0
Conelog Screw-Line
3.3	0	0	0	0
3.8	0	0	0	0
4.3	0	0	0	0
5.0	0	0	0	0
Implant Direct Legacy2
3.2	0	0	0	0
Osstem TS
Mini	X	0	X	X
Regular	X	0	X	X
BioHorizons Internal
3.0	X	0	X	X
3.5	X	0	X	X
4.5	X	0	X	X
5.7	X	0	X	X
MegaGen Xpeed
AnyRidge Internal
3.5	X	0	X	X

X: Not included in this submission

O: Included in this submission

TruAbutment DS

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.

Design Limitation for TruAbutment DS

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)	3.3 ~ 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

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Image /page/10/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 bold, sans-serif font, stacked above the letters "ru", which are in a smaller, cursive font. The "A" in "Abutment" is stylized to resemble a screw or bolt, possibly indicating the company's focus or industry.

TruBase

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. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

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/11/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 stylized to appear as if they are connected. To the left of the text, there is a graphic of a screw, also in blue, which adds a visual element related to construction or engineering.

Indication for Use

TruAbutment DS

· Astra OsseoSpeed EV (K130999, K120414) : 3.0, 3.6, 4.2, 4.8, 5.4 mm.
· Biomet 3i Full OSSEOTITE Tapered Certain (K130949) : 3.25, 4.0, 5.0, 6.0 mm.
· DIO UF (II) Internal Submerged (K161987, K170608, K173975) : 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (Narrow, Regular) mm.
· Neoss ProActive® (K083561) : 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm.
· Osstem TS (K161604) : 3.0, 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) mm.
· Camlog Screw-Line (K083496) : 3.3, 3.8, 4.3, 5.0, 6.0 mm.
· Conelog Screw-Line (K113779) : 3.3, 3.8, 4.3, 5.0 mm.
· Implant Direct Legacy2 (K192221) : 3.2 mm.
· BioHorizons Internal Implant System (K093321, K143022, K071638) : 3.0. 3.4. 3.8. 4.6. 5.8 mm.
· MegaGen AnyRidge Internal Implant (K140091) : 3.5, 4.0, 4.5, 5.0, 5.5 (3.5) mm.

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

TruBase

. Astra OsseoSpeed EV (K130999): 3.0 mm.
Biomet 3i Full OSSEOTITE Tapered Certain (K130949): 3.25.4.0, 5.0, 6.0 mm.
DIO UF(II) Internal Submerged (K161987, K170608, K173975): 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, . 6.5, 7.0 (Narrow, Regular) mm.
. Neoss ProActive® (K083561): 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm.
Camlog Screw-Line (K083496): 3.3, 3.8, 4.3, 5.0, 6.0 mm.
Conelog Screw-Line (K113779): 3.3, 3.8, 4.3, 5.0 mm.
Implant Direct Legacy2 (K192221): 3.2 mm. ●

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Image /page/12/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is blue and white. The word "Abutment" is written in white letters on a blue background. The letters "ru" are written in blue letters on a white background. The logo has a jagged edge on the left side.

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

ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
AstraOsseoSpeedEV(K130999)(K120414)	3.0	8	26301	3.0	Internal Splineconnection"Index System"
		9	26302
		11	26303
		13	26304
		15	26305
	3.6	6	26310
		8	26311
		9	26312	3.6
		11	26313
		13	26314
		15	26315
		17	26316
4.2	6	26320
		8	26321	4.2
		9	26322
		11	26323
		13	26324
		15	26325
		17	26326
4.8	6	26340	4.8
		8		26341
		9		26342
		11		26343
		13		26344
		15		26345
		17	26346
5.4	6	26360	5.4
		8		26361
		9		26362
		11		26363
		13		26364
		15	26365
	3.25	8.5	IENT3285	3.4
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
Biomet 3i FullOSSEOTITETaperedCertain(K130949)	4.0	10	IFNT3210	4.1	Image: Internal Hex Connection
		11.5	IFNT3211
		13	IFNT3213
		15	IFNT3215
		8.5	IFNT485
		10	IFNT410
		11.5	IFNT411
		13	IFNT413
		15	IFNT415
	5.0	8.5	IFNT585	5.0	Image: Internal Hex Connection
		10	IFNT510
		11.5	IFNT511
		13	IFNT513
		15	IFNT515
	6.0	8.5	IFNT685
		10	IFNT610
		11.5	IFNT611
				6.0
		13	IFNT613
		15	IFNT615
DIO UF (II)InternalSubmergedImplant(K161987)(K170608)(K173975)	3.3	8.5	UF(II)N 3308S	Narrow(K161987)	Image: Internal Hex Connection
		10	UF(II)N 3310S
		11.5	UF(II)N 3311S
		13	UF(II)N 3313S
		15	UF(II)N 3315S
	3.8	8.5	UF(II) 3808S
		10	UF(II) 3810S
		11.5	UF(II) 3811S
		13	UF(II) 3813S
		15	UF(II) 3815S	Regular(K170608)
		16	UF(II) 3816S
	4.0	7	UF(II) 4007S
		8.5	UF(II) 4008S
		10	UF(II) 4010S
		11.5	UF(II) 4011S
		13	UF(II) 4013S
		15	UF(II) 4015S
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
	4.5	16	UF(II) 4016S
		7	UF(II) 4507S
		8.5	UF(II) 4508S
		10	UF(II) 4510S
		11.5	UF(II) 4511S
		13	UF(II) 4513S
		15	UF(II) 4515S
		16	UF(II) 4516S
	5.0	7	UF(II) 5007S
		8.5	UF(II) 5008S
		10	UF(II) 5010S
		11.5	UF(II) 5011S
		13	UF(II) 5013S
		15	UF(II) 5015S
		16	UF(II) 5016S

	5.5	7	UF(II) 5507S
		8.5	UF(II) 5508S
		10	UF(II) 5510S
		11.5	UF(II) 5511S
		13	UF(II) 5513S
		15	UF(II) 5515S
		16	UF(II) 5516S

	6.0	7	UF(II) 6007S
		8.5	UF(II) 6008S
		10	UF(II) 6010S
		11.5	UF(II) 6011S
		13	UF(II) 6013S
	6.5	7	UF(II) 6507S	Wide(K173975)
		8.5	UF(II) 6508S
		10	UF(II) 6510S
		11.5	UF(II) 6511S
		13	UF(II) 6513S
	7.0	7	UF(II) 7007S
		8.5	UF(II) 7008S
		10	UF(II) 7010S
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
NeossProActive®(K083561)	3.25	13	UF(II) 7013S	3.5(NP)	Image: Internal Hex Connection
		9	21176
		11	21177
		13	21178
		15	21179
	3.5	7	21181
		9	21182
		11	21183
		13	21184
		15	21185
		17	21186
	4.0	7	21187	4.0(SP)
		9	21188
		11	21189
		13	21190
		15	21191
		17	21192
	4.5	7	21193
		9	21194
		11	21195
		13	21196
		15	21197
		17	21198
	5.0	7	21199
		9	21200
		11	21201
		13	21202
		15	21203
		17	21205
	5.5	9	21206
		11	21207
		13	21208
		15	21211
	6.0	9	21212
		11	21213
		13	21221
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
	3.0	15	21222		Image: Internal Hex connection
		8.5	TS3M3008S	2.1(Mini)
		10	TS3M3010S
		11.5	TS3M3011S
		13	TS3M3013S
	3.5 (3.7)	8.5	TS3M3508S
		10	TS3M3510S
		11.5	TS3M3511S
		13	TS3M3513S
	4.0 (4.2)	7	TS3S4007S
		8.5	TS3S4008S
		10	TS3S4010S
		11.5	TS3S4011S
		13	TS3S4013S
OSSTEM TS(K161604)	4.5 (4.6)	7	TS3S4507S
		8.5	TS3S4508S
		10	TS3S4510S
		11.5	TS3S4511S
		13	TS3S4513S
	5.0 (5.1)	7	TS3S5007S
			8.5	TS3S5008S
		10	TS3S5010S
		11.5	TS3S5011S
		13	TS3S5013S
	6.0 (6.0)	7	TS3S6007S
		8.5	TS3S6008S
		10	TS3S6010S
		11.5	TS3S6011S
		13	TS3S6013S
	7.0 (6.8)	7	TS3S7007S
		8.5	TS3S7008S
		10	TS3S7010S
		11.5	TS3S7011S
		13	TS3S7013S
	3.3	11	K1046.3311	3.3
		13	K1046.3313
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
CamlogScrew-Line(K083496)	3.8	16	K1046.3316	3.8	Tube-in-tubeconnection
	3.8	9	K1046.3809
	3.8	11	K1046.3811
	3.8	13	K1046.3813
	4.3	16	K1046.3816	4.3
	4.3	9	K1046.4309
	4.3	11	K1046.4311
	4.3	13	K1046.4313
CamlogScrew-Line(K083496)	4.3	16	K1046.4316	5.0
5.0	9	K1046.5009
5.0	11	K1046.5011
5.0	13	K1046.5013
6.0	16	K1046.5016	6.0
6.0	9	K1046.6009
6.0	11	K1046.6011
6.0	13	K1046.6013
6.0	16	K1046.6016	6.0	Conical abutmentconnectoin
ConelogScrew-Line(K113779)	3.3	9			C1065.3309
	3.3	11			C1065.3311
	3.3	13			C1065.3313
	3.3	16	C1065.3316
	3.8	7	C1065.3807		3.8
	3.8	9	C1065.3809
	3.8	11	C1065.3811
	3.8	13	C1065.3813
ConelogScrew-Line(K113779)	3.8	16	C1065.3816		4.3
4.3	7	C1065.4307
4.3	9	C1065.4309
4.3	11	C1065.4311
5.0	4.3	13	C1065.4313		5.0
5.0	16	C1065.4316
5.0	7	C1065.5007
5.0	9	C1065.5009
5.0	5.0	11	C1065.5011	5.0
5.0	5.0	13	C1065.5013
5.0	5.0	16	C1065.5016
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
ImplantDirectLegacy2(K192221)	3.2	8	823208	3.0	Image: Internal Hex Connection
		10	823210
		11.5	823211
		13	823213
		16	823216
BioHorizonsLaser-Lok(K093321)	3.0	10.5	TLX3010	3.0	Image: Internal Hex Connection
		12	TLX3012
		15	TLX3015
	3.4	9	TLX3409	3.0
		10.5	TLX3410
		12	TLX3412
		15	TLX3415
	3.4	18	TLX3418	3.0
	3.8	9	TLX3809	3.5
		10.5	TLX3810
		12	TLX3812
		15	TLX3815
	3.8	18	TLX3818	3.5
BioHorizonsTaperedInternal(K071638)(K143022)	4.6	7.5	TLX4607	4.5
		9	TLX4609
		10.5	TLX4610
		12	TLX4612
		15	TLX4615
		18	TLX4618
		7.5	TLX5807
		9	TLX5809
	5.8	10.5	TLX5810	5.7
		9	TLX5809
		10.5	TLX5810
		12	TLX5812
		15	TLX5815
		18	TLX5818
		7	FANIHX3507C
		8	FANIHX3508C
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength(mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-AbutmentConnection
MegaGenXpeedAnyRidge®(K140091)	3.5	10	FANIHX3510C	3.5	Image: Internal Hex Connection
		11.5	FANIHX3511C
		13	FANIHX3513C
		15	FANIHX3515C
		18	FANIHX3518C
	4.0	7	FANIHX4007C
		8	FANIHX4008C
		10	FANIHX4010C
		11.5	FANIHX4011C
		13	FANIHX4013C
		15	FANIHX4015C
	4.5	7	FANIHX4507C
		8	FANIHX4508C
		10	FANIHX4510C
		11.5	FANIHX4511C
		13	FANIHX4513C
		15	FANIHX4515C
		18	FANIHX4518C
5.0	7	FANIHX5007C
	8	FANIHX5008C
	10	FANIHX5010C
	11.5	FANIHX5011C
	13	FANIHX5013C
	15	FANIHX5015C
	18	FANIHX5018C
5.5	7	FANIHX5507C
	8	FANIHX5508C
	10	FANIHX5510C
	11.5	FANIHX5511C
	13	FANIHX5513C
	15	FANIHX5515C
	18	FANIHX5518C

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

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Image /page/13/Picture/0 description: The image features a logo for "Abutment ru" in a stylized, modern design. The word "ABUTMENT" is prominently displayed in a bold, sans-serif font, with the "A" slightly larger than the other letters. To the left of the word, there is a graphic resembling a screw or threaded cylinder, suggesting a connection to engineering or construction. The letters "ru" are placed to the right of "ABUTMENT" in a smaller, italicized font, possibly indicating a website domain or regional affiliation.

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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 larger, bold, sans-serif font, with the "A" in blue and the rest of the word in white. The letters "ru" are in a smaller, cursive font, also in blue, and are positioned to the right and slightly below the word "Abutment". The logo has a tooth-like design incorporated into the "A" of "Abutment", suggesting a dental or medical focus.

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Image /page/15/Picture/0 description: The image features a logo for "Abutment ru" in a stylized, modern design. The word "ABUTMENT" is prominently displayed in a bold, sans-serif font, with the "A" slightly larger than the other letters. To the left of the word, there is a graphic resembling a screw or threaded cylinder, suggesting a connection to engineering or construction. The letters "ru" are placed to the right of "ABUTMENT" in a smaller, italicized font, possibly indicating a website domain or regional affiliation.

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Image /page/16/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 and is colored in a bright blue. To the left of the word "ru" is a graphic of a screw, also in blue, which is likely meant to represent a dental implant abutment.

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Image /page/17/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a sans-serif font, with the "A" being larger than the other letters. The letters "ru" are in a larger, bolder font and are placed to the right of the word "Abutment". To the left of the word "Abutment" is a graphic of a screw.

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Image /page/18/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a sans-serif font, with the "A" being larger than the other letters. The letters "ru" are in a larger, bolder font and are placed to the right of the word "Abutment". To the left of the word "Abutment" is a graphic of a screw.

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a bold, sans-serif font, with the letters "ABUTMENT" stacked on top of each other. The letters "ru" are in a smaller, sans-serif font and are located to the right of the word "Abutment". The entire logo is in a bright blue color. The bottom of the logo has a design that looks like a screw.

{20}------------------------------------------------

Image /page/20/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is in a bright blue color and features the word "Abutment" in a bold, sans-serif font. Below the word "Abutment" is the letters "ru" in a larger, stylized font. The logo has a modern and professional look.

Summary of Technological Characteristic

The subject base and blank devices are identical to the K203649 base and blank devices besides the compatible implant bodies. They are substantially equivalent in intended use, the material and connection interfaces to the implants identical for each diameter and connection type. A 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 (K203649)
Indications for Use	TruAbutment DS is a patient-specific CAD/CAM abutment,directly connected to endosseous dental implants and isintended for use as an aid in prosthetic rehabilitation. It iscompatible with the following systems:Astra OsseoSpeed EV (K130999, K120414): 3.0, 3.6, 4.2, 4.8, 5.4 mm.Biomet 3i Full OSSEOTITE Tapered Certain (K130949): 3.25, 4.0, 5.0, 6.0 mm.DIO UF(II) Internal Submerged (K161987, K170608,K173975): 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (Narrow, Regular)Neoss ProActive® (K083561): 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm.Osstem TS (K161604): 3.0, 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8)(Mini, Regular) mm.Camlog Screw-Line (K083496): 3.3, 3.8, 4.3, 5.0, 6.0 mm.	The TruAbutment DS is patient specific. CAD/CAM abutment,directly connected to endosseous dental implants and is intendedfor use as an aid in prosthetic rehabilitation. It is compatible withthe following systems:MIS C1 Conical Connection Implant (K172505, K112162): 3.3 (NP), 3.75, 4.2, 5.0 (SP, WP) mm.Neodent Implant System - GM Helix (K163194, K180536): 3.5, 3.75, 4.0, 4.3, 5.0 (3.0), 6.0 (3.0) mm.Nobel Biocare Groovy Implants (K050258): 3.5, 4.3, 5.0, 6.0 (NP, RP, WP, 6.0) mm.Straumann BLX Implant (K173961, K181703, K191256): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB) mm.Straumann Tissue Level Implant (K111357): 3.3 (NNC) mm.All digitally designed abutments and/or copings for use with theTruAbutment DS abutments are intended to be sent to aTruAbutment-validated milling center for manufacture.
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K203649)
	Conelog Screw-Line (K113779): 3.3, 3.8, 4.3, 5.0 mm.Implant Direct Legacy2 (K192221): 3.2 mm.BioHorizons Internal (K093321, K071638, K143022): 3.0, 3.4, 3.8, 4.6, 5.8 mm.MegaGen AnyRidge Internal Implant (K140091): 3.5, 4.0, 4.5, 5.0, 5.5 (3.5) mm.All digitally designed abutments and/or copings for use withthe TruAbutment DS abutments are intended to be sent to aTruAbutment-validated milling center for manufacture.TruAbutment DS is compatible with the following devices:Astra OsseoSpeed EV (K130999, K120414)Implant Body Diameter (mm): 3.0 /Implant Platform (mm):3.0 / Internal Spline connection.Implant Body Diameter (mm): 3.6 /Implant Platform (mm):3.6 / Internal Spline connection.Implant Body Diameter (mm): 4.2 /Implant Platform (mm):4.2 / Internal Spline connection.Implant Body Diameter (mm): 4.8 /Implant Platform (mm):4.8 / Internal Spline connection.Implant Body Diameter (mm): 5.4 /Implant Platform (mm):5.4/ Internal Spline connection.Biomet 3i Full OSSEOTITE Tapered Certain(K130949)
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K203649)
	Implant Body Diameter (mm): 3.25 / Implant Platform (mm): 3.4 / Internal Hex connection.
	Implant Body Diameter (mm): 4.0 / Implant Platform (mm): 4.1 / Internal Hex connection.
	Implant Body Diameter (mm): 5.0 / Implant Platform (mm): 5.0 / Internal Hex connection.
	Implant Body Diameter (mm): 6.0 / Implant Platform (mm): 6.0 / Internal Hex connection.
	DIO UF(II) Internal Submerged (K161987, K170608, K173975)
	Implant Body Diameter (mm): 3.3 /Implant Platform (mm): Narrow / Internal Hex connection.
	Implant Body Diameter (mm): 3.8 /Implant Platform (mm): Regular / Internal Hex connection.
	Implant Body Diameter (mm): 4.0 /Implant Platform (mm): Regular / Internal Hex connection.
	Implant Body Diameter (mm): 4.5 /Implant Platform (mm): Regular / Internal Hex connection.
	Implant Body Diameter (mm): 5.0 /Implant Platform (mm): Regular / Internal Hex connection.
	Implant Body Diameter (mm): 5.5 /Implant Platform (mm): Regular / Internal Hex connection.
	Implant Body Diameter (mm): 6.0 /Implant Platform (mm): Wide / Internal Hex connection.
	Implant Body Diameter (mm): 6.5 /Implant Platform (mm): Wide / Internal Hex connection.
	Implant Body Diameter (mm): 7.0 /Implant Platform (mm):
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K203649)
	Wide / Internal Hex connection.Neoss ProActive® (K083561)Implant Body Diameter (mm): 3.25 / Implant Platform (mm): 3.5 / Internal Hex connection.Implant Body Diameter (mm): 3.5 /Implant Platform (mm): 4.0 / Internal Hex connection.Implant Body Diameter (mm): 4.0 /Implant Platform (mm): 4.0 / Internal Hex connection.Implant Body Diameter (mm): 4.5 /Implant Platform (mm): 4.0 / Internal Hex connection.Implant Body Diameter (mm): 5.0 /Implant Platform (mm): 4.0 / Internal Hex connection.Implant Body Diameter (mm): 5.5 /Implant Platform (mm): 4.0 / Internal Hex connection.Implant Body Diameter (mm): 6.0 /Implant Platform (mm) 4.0 / Internal Hex connection.Osstem TS (K161604)Implant Body Diameter (mm): 3.0 / Implant Platform (mm): 2.1 / Internal Hex connection.Implant Body Diameter (mm): 3.5 / Implant Platform (mm): 2.1 / Internal Hex connection.Implant Body Diameter (mm): 4.0 / Implant Platform (mm): 2.5/ Internal Hex connection.Implant Body Diameter (mm): 4.5 / Implant Platform (mm): 2.5 / Internal Hex connection.Implant Body Diameter (mm): 5.0/ Implant Platform (mm):
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K203649)
	2.5 / Internal Hex connection.Implant Body Diameter (mm): 6.0 / Implant Platform (mm):2.5 / Internal Hex connection.Implant Body Diameter (mm): 7.0 / Implant Platform (mm):2.5 / Internal Hex connection.Camlog Screw-Line (K083496)Implant Body Diameter (mm): 3.3 / Implant Platform (mm):3.3 / Tube-in-tube connection.Implant Body Diameter (mm): 3.8 /Implant Platform (mm):3.8 / Tube-in-tube connection.Implant Body Diameter (mm): 4.3 /Implant Platform (mm):4.3 / Tube-in-tube connection.Implant Body Diameter (mm): 5.0 /Implant Platform (mm):5.0 / Tube-in-tube connection.Implant Body Diameter (mm): 6.0 /Implant Platform (mm):6.0/ Tube-in-tube connection.Conelog Screw-Line (K113779)Implant Body Diameter (mm): 3.3 /Implant Platform (mm):3.3 / Conical abutment connection.Implant Body Diameter (mm): 3.8 /Implant Platform (mm):3.8 / Conical abutment connection.Implant Body Diameter (mm): 4.3 /Implant Platform (mm):4.3 / Conical abutment connection.Implant Body Diameter (mm): 5.0 /Implant Platform (mm):5.0 / Conical abutment connection.
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K203649)
	Implant Direct Legacy2 (K192221)Implant Body Diameter (mm): 3.2 /Implant Platform(mm): 3.0 / Internal Hex connection.
	BioHorizons Internal Implant System (K093321, K071638,K143022)Implant Body Diameter (mm): 3.0/ Implant Platform (mm):3.0 / Internal Hex connection.Implant Body Diameter (mm): 3.4/ Implant Platform (mm):3.0 / Internal Hex connection.Implant Body Diameter (mm): 3.8/ Implant Platform (mm):3.5 / Internal Hex connection.Implant Body Diameter (mm): 4.6/ Implant Platform (mm):4.5 / Internal Hex connection.Implant Body Diameter (mm): 5.8/ Implant Platform (mm):5.7 / Internal Hex connection.
	MegaGen AnyRidge Internal Implant System (K140091)Implant Body Diameter (mm): 3.5/ Implant Platform (mm):3.5 / Internal Hex connection.Implant Body Diameter (mm): 4.0/ Implant Platform (mm):3.5 / Internal Hex connection.Implant Body Diameter (mm): 4.5/ Implant Platform (mm):3.5 / Internal Hex connection.Implant Body Diameter (mm): 5.0/ Implant Platform (mm):3.5 / Internal Hex connection.Implant Body Diameter (mm): 5.5/ Implant Platform (mm):3.5 / Internal Hex connection.
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K203649)
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/implant interface(mm): 0.4Minimum and Maximum length of abutment post (lengthabove the abutment collar/gingival height) (mm): 4.0~7.0	Minimum and Maximum abutment angle (°): 0~~25Minimum and Maximum Gingival (Cuff) Height (mm): 0.5~~6.0Minimum and Maximum diameter at abutment/implant interface(Ø,mm): 3.3~~8.0Minimum and Maximum length of abutment (mm): 6.0~~11.0Minimum wall thickness at the abutment/implant interface (mm):0.4~~0.9Minimum and Maximum length of abutment post (length above theabutment collar/gingival height) (mm): 4.0~~7.0
Connection	Internal Connections	Internal Connections
Sterility	Packaged non-sterile	Packaged non-sterile
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
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 tothe abutment.

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Image /page/21/Picture/0 description: The image is a logo for a company called "Abutment ru". The word "Abutment" is in a bold, 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. The entire logo is in a light blue color.

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Image /page/22/Picture/0 description: The image contains a logo with the word "ABUTMENT" in a bold, sans-serif font, stacked above the letters "ru" in a cursive font. To the left of the word "ABUTMENT" is a stylized image of a screw. The entire logo is in a light blue color. The logo appears to be for a company or product related to dental implants or abutments.

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Image /page/23/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 stacked on top of the letters "ru", which are in a cursive font. To the left of the word "ru" is a graphic of a screw.

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Image /page/24/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 stacked on top of the letters "ru", which are in a cursive font. To the left of the word "ru" is a graphic of a screw.

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Image /page/25/Picture/0 description: The image shows a logo for a company called "Abutment Tru". The word "Abutment" is in a sans-serif font and is stacked on top of the word "Tru", which is in a cursive font. To the left of the word "Tru" is a graphic of a screw.

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Image /page/26/Picture/0 description: The image is a logo for a company called "Abutment ru". The word "Abutment" is in a bold, sans-serif font, with the letters in white and the background in blue. The letters "ru" are in a smaller, sans-serif font, with the letters in white and the background in blue. To the left of the letters "ru" is a graphic of a screw, also in blue and white.

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Image /page/27/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 larger, bolder font. To the left of the letters "ru" is a jagged line that resembles a tooth. The entire logo is in a light blue color.

TruBase

Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruBase	TruBase (K203649)
Indications for Use	TruBase is a titanium component that is directly connected toendosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. Itis indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatiblewith the following systems:Astra OsseoSpeed EV (K130999): 3.0 mm.Biomet 3i Full OSSEOTITE Tapered Certain (K130949): 3.25, 4.0, 5.0, 6.0 mm.DIO UF(II) Internal Submerged (K161987, K170608,K173975): 3.3, 3.8, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0 (Narrow, Regular) mm.Neoss ProActive® (K083561): 3.25, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0 (NP, SP) mm.Camlog Screw-Line (K083496): 3.3, 3.8, 4.3, 5.0, 6.0 mm.Conelog Screw-Line (K113779):3.3, 3.8, 4.3, 5.0 mm.Implant Direct Legacy2 (K192221): 3.0 mm.All digitally designed zirconia superstructures for use with theTruBase are intended to be sent to a TruAbutment-validatedmilling center for manufacture.	TruBase is a titanium component that is directly connected toendosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. Itis indicated for a screw-retained single tooth or cement-retained single tooth and bridge restorations. It is compatiblewith the following systems:MIS C1 Conical Connection Implant (K172505, K112162): 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP) mm.Neodent Implant System - GM Helix (K163194, K180536): 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0(3.0) mm.Nobel Biocare Groovy Implants (K050258): 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0) mm.Straumann BLX Implant (K173961, K181703, K191256): 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB) mm.Straumann Tissue Level Implant (K111357): 3.3 (NNC) mm.All digitally designed zirconia superstructures for use with theTruBase are intended to be sent to a TruAbutment-validatedmilling center for manufacture.
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruBase	TruBase (K203649)
	TruBase is compatible with the following devices:
	Astra OsseoSpeed EV(K130999)Implant Body Diameter (mm): 3.0 / Implant Platform(mm): 3.0 / Internal Spline connection.
	Biomet 3i Full OSSEOTITE Tapered Certain (K130949)Implant Body Diameter (mm): 3.25 / Implant Platform(mm): 3.4 / Internal Hex connection.Implant Body Diameter (mm): 4.0 / Implant Platform(mm): 4.1 / Internal Hex connection.Implant Body Diameter (mm): 5.0 / Implant Platform(mm): 5.0 / Internal Hex connection.Implant Body Diameter (mm): 6.0 / Implant Platform
	(mm): 6.0 / Internal Hex connection.DIO UF(II) Internal Submerged (K161987, K170608,K173975)Implant Body Diameter (mm): 3.3 / Implant Platform(mm): Narrow / Internal Hex connection.Implant Body Diameter (mm): 3.8 / Implant Platform(mm): Regular/ Internal Hex connection.
	Implant Body Diameter (mm): 4.0 / Implant Platform(mm): Regular / Internal Hex connection.Implant Body Diameter (mm): 4.5 / Implant Platform(mm): Regular / Internal Hex connection.Implant Body Diameter (mm): 5.0 / Implant Platform(mm): Regular / Internal Hex connection.Implant Body Diameter (mm): 5.5 / Implant Platform(mm): Regular / Internal Hex connection.Implant Body Diameter (mm): 6.0 / Implant Platform(mm): Wide / Internal Hex connection.
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruBase	TruBase (K203649)
	Implant Body Diameter (mm): 6.5 / Implant Platform(mm): Wide / Internal Hex connection.Implant Body Diameter (mm): 7.0 / Implant Platform(mm): Wide / Internal Hex connection.Neoss ProActive® (K083561)Implant Body Diameter (mm): 3.25 / Implant Platform(mm): 3.5 / Internal Hex connection.Implant Body Diameter (mm): 3.5 / Implant Platform(mm): 4.0 / Internal Hex connection.Implant Body Diameter (mm): 4.0 / Implant Platform(mm): 4.0 / Internal Hex connection.Implant Body Diameter (mm): 4.5 / Implant Platform(mm): 4.0 / Internal Hex connection.Implant Body Diameter (mm): 5.0 / Implant Platform(mm): 4.0 / Internal Hex connection.Implant Body Diameter (mm): 6.0 / Implant Platform(mm) 4.0 / Internal Hex connection.Camlog Screw-Line (K083496)Implant Body Diameter (mm): 3.3 / Implant Platform(mm): 3.3 / Tube-in-tube connection.Implant Body Diameter (mm): 3.8 / Implant Platform(mm): 3.8 / Tube-in-tube connection.Implant Body Diameter (mm): 4.3 / Implant Platform(mm): 4.3 / Tube-in-tube connection.Implant Body Diameter (mm): 5.0 / Implant Platform(mm): 5.0 / Tube-in-tube connection.Implant Body Diameter (mm): 6.0 / Implant Platform(mm): 6.0/ Tube-in-tube connection.
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruBase	TruBase (K203649)
	Conelog Screw-Line (K113779)Implant Body Diameter (mm): 3.3 / Implant Platform(mm): 3.3 / Conical abutment connection.Implant Body Diameter (mm): 3.8 / Implant Platform(mm): 3.8 / Conical abutment connection.Implant Body Diameter (mm): 4.3 / Implant Platform(mm): 4.3 / Conical abutment connection.Implant Body Diameter (mm): 5.0 / Implant Platform(mm): 5.0 / Conical abutment connection.Implant Direct Legacy2 (K192221)Implant Body Diameter (mm): 3.2 / Implant Platform(mm): 3.0 / Internal Hex connection.
CAD Design Limits	Maximum angulation (°): 0~~15Maximum cuff height (mm): 0.5~~5.0Minimum and Maximum diameter at the abutment/implant (Ø,mm): 5.0~ 8.0Minimum thickness (mm): 0.4Minimum post height length above the abutmentcollar/gingival height (mm): 4~6	Maximum angulation (°): 0~~15Maximum cuff height (mm) 0.5~~5.0Minimum and Maximum diameter at the abutment/implant (Ø,mm): 5.0~ 8.0Minimum thickness (mm): 0.4Minimum post height length above the abutmentcollar/gingival height (mm): 4~6
Abutment Base andScrew Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
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.
Material ofSuperstructure	InCoris Zi (K123664)	InCoris Zi (K123664)
Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruBase	TruBase (K203649)
Material of Cement	RelyX Unicem 2Automix by 3M ESPE (K100756)	RelyX Unicem 2Automix by 3M ESPE (K100756)
Manufacturingprocesses	TruAbutment-validated milling center	TruAbutment-validated milling center
End-User Sterilization	Moist steam sterilization	Moist steam sterilization

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Image /page/28/Picture/0 description: The image shows a logo for a company called "Abutment". The word "Abutment" is written in a bold, sans-serif font, with the letters "A" and "B" being larger than the other letters. To the right of the word "Abutment" are the letters "ru" in a smaller, cursive font. The entire logo is in a bright blue color. The left side of the "A" has a jagged edge, resembling the teeth of a gear.

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Image /page/29/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a larger, bold, white font with a blue background. The letters "ru" are in a smaller, italicized, white font with a blue background. To the left of the text is a graphic of a screw.

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Image /page/30/Picture/0 description: The image features 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 stylized in a cursive-like font and are positioned to the right and slightly below the word "Abutment". A graphic resembling the side view of a screw is placed to the left of the word "Abutment". The entire logo is in a bright blue color.

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Image /page/31/Picture/0 description: The image shows a logo with the word "Abutment" in a large, bold font, stacked on top of the letters "ru" in a smaller, italicized font. The entire logo is in a bright blue color. To the left of the word "ru" is a stylized image of a screw.

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Image /page/32/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 bold, sans-serif font, stacked above the letters "ru", which are also in blue. To the left of the "ru" is a stylized graphic that resembles a screw or a gear, also in blue, adding a visual element related to engineering or construction.

Substantial Equivalence Discussion

The subject device (TruAbutment DS) is substantially equivalent in indications and design principles to the primary predicate device listed above. The provided tables compare 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 (TruAbutment DS) is substantially equivalent in intended use to the primary predicate device (K203649). 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 (K203649) 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 (K203649) are related to the compatible OEM implant lines. None of these minor differences impact substantial equivalences because all IFUS express equivalence intended to be used to facilitate dental prosthetic restorations, and the indications are expressed equivalently using different specific wording.

Design Parameter	Subject Device(TruAbutment DS)Design Limit	Primary PredicateDevice (K203649)Design Limit
Minimum and Maximum abutment angle (°)	0 ~ 25	0 ~ 25
Minimum and Maximum cuff height (mm)	0.5 ~ 6.0	0.5 ~ 6.0
Minimum and Maximum diameter atabutment/implant interface (Ø, mm)	3.3 ~ 8.0	3.3 ~ 8.0
Minimum and Maximum length of the abutment(mm)	6~11	6 ~ 11
Minimum wall thickness at abutment/implantinterface (mm)	0.4	0.4 ~ 0.9
Minimum and Maximum length of abutmentpost(length above the abutment collar / gingivalheight) (mm)	4.0 ~ 7.0	4.0 ~ 7.0

The subject device and the predicate device indications and design parameters are identical.

The following subject device (TruBase) is substantially equivalent in indications and design principles to the primary predicate device (K203649). The subject device (TruBase) and the primary predicate device (K203649) have internal implant interface connections and are made of

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Image /page/33/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 bold, sans-serif font, stacked above the letters "ru", which are also in a similar font but larger in size. To the left of the "ru" is a stylized image of a screw or bolt, also in blue, which adds a visual element related to construction or engineering.

Design Parameter	Subject Device(TruBase)Design Limit	Primary Predicate Device(K203649) Design Limit
Minimum and Maximum angulation (°)	0 ~ 15	0 ~ 15
Minimum and Maximum gingival (cuff)height (mm)	0.5 ~ 5.0	0.5 ~ 5.0
Minimum and Maximum diameter atabutment/implant interface (Ø, mm)	5.0 ~ 8.0	5.0 ~ 8.0
Minimum thickness (mm)	0.4	0.4
Minimum and Maximum length of abutmentpost(length above the abutment collar / gingivalheight) (mm)	4.0 ~ 6.0	4.0 ~ 6.0

Ti-6Al-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 (K203649). Sterilization 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 (K203649).

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.

MR Environment Condition

Non-clinical worst-case MRI review was performed to evaluate the metallic DS, TruBase in the MRI environment using scientific rationale and published literature (e.g., Woods, Terry O., Jana G. Delfino, and Sunder Rajan. "Assessment of Maggetically Induced Displ acement Force and Torque on Metal Alloys Used in Medical Devices." Journal of Testin g and Evaluation 49.2 (2019): 783-795), based on the entire system including all variatio ns (all compatible implant bodies, dental abutments, and fixation screws) and material co mposition. Rationale addressed parameters per the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment," including ma gnetically induced displacement force and torque.

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Image /page/34/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, with the "A" slightly larger than the other letters. Below "Abutment" is "ru" in a similar font. To the left of the text is a stylized graphic that resembles a screw or a gear, also in blue, which adds a visual element related to engineering or construction.

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
The tests below 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 substantial equivalence with the reference devices.

Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments," and it consisted of testing finished assembled implant/abutment systems of the worstcase scenario through fatigue testing.

Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, using the OEM implant body, abutment, and abutment screw. The reverse engineering included an assessment of maximum and minimum dimensions of critical design aspects and tolerances of the OEM implant body, abutment screws, along with cross-sectional images of the submission device and compatible implant body. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with reference devices.

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

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 reference devices. TruAbutment DS, TruBase, and predicate devices 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.)