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:
• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
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 patientspecific prosthetic restorations, such as copings or crowns. It is indicated for a screw-retained single tooth or cementretained single tooth and bridge restorations. It is compatible with the following systems:

· Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular)
· Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm
· BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0. 3.4, 3.8 mm
· Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
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 screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:
(1) For fixing into the endosseous implant
(2) For dental laboratory use during construction of related restoration.
The abutment is placed over the implant shoulder and mounted into the implant with the provided screw. The design and manufacturing of the patient-specific abutments take into consideration the shape of the final prosthesis based on the patient's intra-oral indications using CAD/CAM system during the manufacturing. All manufacturing processes of TruAbutment DS are conducted at the TruAbutment milling center and provided to the authorized end-user as a final patient-specific abutment.

TruBase consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. 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 a various prosthetic platform diameters (OSSTEM TSIII SA 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) and Astra EV 3.6, 4.2, 4.8, 5.4mm and BioHorizons Internal 3.0. 3.5. 4.5. 5.7mm and Straumann Tissue Level: 4.1(RN), 4.8(RN), 6.5(WN). The TruBase Screws are composed of titanium alloy per ASTM F136.
CAD/CAM customized superstructure that composes the final abutment 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. TruBase is provided non-sterile therefore must be sterilized after the cementation of the customized superstructure on the TruBase.

AI/ML Overview

The provided text describes a 510(k) premarket notification for two dental devices, TruAbutment DS and TruBase. The submission asserts substantial equivalence to a predicate device based on material, intended use, and mechanical testing. The document focuses on regulatory compliance and mechanical performance, rather than clinical efficacy measured by expert assessments or comparative effectiveness studies with human readers.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on established international standards for dental implants and abutments and ensuring mechanical integrity. The reported performance indicates that the devices met these criteria.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Mechanical Performance	Fatigue Test per ISO 14801:2016	Met the criteria of the standard. Fatigue limit data for all implant lines demonstrated construct strengths suitable for intended use.
Sterilization	End User Steam Sterilization Test per ISO 17665-1:2006, 17665-2:2009, and ANSI/AAMI ST79:2010	Met the criteria of the standard (leveraged from predicate device). The performed validation method is the same as the predicate devices.
Biocompatibility	Biocompatibility tests per ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010	Met the criteria of the standard (leveraged from predicate device).
Material Composition	Ti-6A1-4V ELI (meets ASTM Standard F-136) for abutment and screws	Devices are made of Ti-6Al-4V ELI, conforming to ASTM F136.
Dimensional Compatibility	Assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images for implant-to-abutment connection.	Testing demonstrated implant to abutment compatibility and established substantial equivalency.
MRI Safety	Worst-case MRI review using scientific rationale and published literature (e.g., Woods et al. 2019) addressing magnetically induced displacement force and torque based on FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment."	Rationale addressed parameters and supports safety in the MRI environment (no specific performance metric, but rather a successful review).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not explicitly state a sample size for the mechanical fatigue testing beyond "worst-case constructs." For other tests (sterilization, biocompatibility, MRI review), specific sample sizes are not provided, though these are typically laboratory-based tests rather than patient-data-based studies.
Data Provenance: The document does not specify the country of origin for any data or whether the data is retrospective or prospective. The studies mentioned (e.g., fatigue testing, sterilization) are engineering and laboratory tests, not clinical studies involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the provided document. The studies described are non-clinical (mechanical, sterilization, biocompatibility, MRI safety) and rely on testing against established engineering and safety standards, rather than expert interpretation of a 'ground truth' in a clinical context.

4. Adjudication Method for the Test Set

This information is not applicable as the described studies are non-clinical laboratory tests and material/design assessments, not studies involving human judgment or adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The submission relates to dental abutments, which are physical medical devices, and does not involve AI or image-based diagnostics requiring human reader performance studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The device is not an algorithm or AI system.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the non-clinical tests is based on:

Established international and national standards (e.g., ISO 14801, ISO 17665, ISO 10993, ASTM F-136, ANSI/AAMI ST79).
Engineering specifications and design limits (e.g., minimum thickness, maximum angle for abutments).
Physical measurements and compatibility assessments (e.g., dimensional analysis and reverse engineering of implant-to-abutment connections).
Scientific rationale and published literature for MRI safety.

8. The Sample Size for the Training Set

This information is not applicable. The devices are physical dental abutments, not AI models that require training data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI model.

In summary, the provided document focuses on demonstrating the substantial equivalence of physical medical devices through adherence to established engineering and safety standards, rather than clinical performance based on human reader assessments or AI model evaluations.

Summary

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

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

Re: K213961

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: June 10, 2022 Received: June 17, 2022

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) K213961

Device Name TruAbutment DS, TruBase

Indications for Use (Describe)

TruAbutment DS

• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm

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)
-------------------------------------------------

| 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.

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Indications for Use

510(k) Number (if known) K213961

Device Name TruAbutment DS, TruBase

Indications for Use (Describe)

TruBase

· Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular)
· Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm
· BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0. 3.4, 3.8 mm
· Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm

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

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CER 801 Subpart D)	□ Over-The-Counter Use (21 CER 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

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 shows a logo for a company called "Abutment". The logo is primarily blue and features the word "Abutment" in a stylized font, with the "A" in uppercase and the rest of the word in lowercase. Below "Abutment", there is a stylized image of a screw or bolt, also in blue. The logo has a modern and professional look.

510(k) Summary K213961

Submitter TruAbutment Inc. Kiyoon Nam 17666 Fitch, Irvine, CA 92614 USA Email: kiyoon.nam@truabutment.com Phone: 1-714-956-1488

Official Correspondent

TruAbutment Inc. Chris Choi 17666 Fitch, Irvine, CA 92614 USA Email: chris.choi@truabutment.com Phone: 1-714-956-1488

Device Information

Trade Name: TruAbutment DS, ● TruBase
Common Name: Endosseous dental implant abutment ●
Classification Name: Abutment, Implant, Dental, ● Endosseous
Product Code: NHA ●
Panel: Dental
Regulation Number: 21 CFR 872.3630 .
Device Class: Class II
Date prepared: 07/13/2022 ●

Predicate Devices/ Reference Devices:

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

Primary Predicate:

TruAbutment DS (K203649) by TruAbutment Inc. ●

Reference Devices for OEM Compatibilities:

Osstem TS Fixture System(K121995) by Osstem Implant Co., Ltd.
Astra OsseoSpeed EV (K120414) by Astra. ●
Biohorizons Laser-Lok 3.0 Implant System (K093321) by Biohorizons Implant Systems, Inc. ●
Biohorizons Tapered Internal Implants (K143022) by Biohorizons Implant Systems, Inc.
Biohorizons Tapered Internal Implant System (K071638) by Biohorizons Implant Systems, Inc.
. Straumann Tissue Level Implant (K122855) by Straumann USA.
Straumann 4mm Short Implants (K202942) by Straumann USA. ●

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Image /page/5/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is in blue and white. The word "Abutment" is in white letters on a blue background. The letters "ru" are in blue and are larger than the word "Abutment". The logo has a stylized image of a screw.

General Description

TruAbutment DS

(1) For fixing into the endosseous implant

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

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

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

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

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)	5.2 ~ 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/6/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in white text with a blue outline, and the letters are capitalized. Below the word "Abutment" is the word "ru" in a large, stylized blue font. To the left of the word "ru" is a graphic of a tooth.

TruBase

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 a various prosthetic platform diameters (OSSTEM TSIII SA 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) and Astra EV 3.6, 4.2, 4.8, 5.4mm and BioHorizons Internal 3.0. 3.5. 4.5. 5.7mm and Straumann Tissue Level: 4.1(RN), 4.8(RN), 6.5(WN). The TruBase Screws are composed of titanium alloy per ASTM F136.

CAD/CAM customized superstructure that composes the final abutment 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. 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 abutment angle	0~15°
Minimum and Maximum Cuff Height	0.5~5 mm
Minimum and Maximum diameter atabutment/implant interface	$Ø$ 6.5mm~ $Ø$ 8.0mm
Minimum Thickness	0.4 mm
Minimum and Maximum length ofabutment post (length above the abutmentcollar/gingival height)	4 ~6 mm

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Image /page/7/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is in blue and features the word "Abutment" in a stylized font. Below the word "Abutment" is a graphic that resembles a screw or bolt. The logo is simple and modern, and the blue color gives it a professional look.

Indication for Use

TruAbutment DS

Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase

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

Osstem TSIII SA (K121995): 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)
Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
BioHorizons Tapered Internal (K093321, K143022, K071638) 3.0, 3.4, 3.8, 4.6, 5.8 mm ●
Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm ●

All digitally designed zirconia superstructure for use with 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 features a logo with the word "ABUTMENT" in white, set against a blue background. The "ru" is stylized in a cursive font and is also in blue. 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.

TruAbutment DS and TruBase are compatible with the following devices:

ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength (mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-Abutment Connection
OSSTEMTSIIISA (K121995)	3.5 (3.7)	8.5mm	TS3M3508S	2.1(Mini)	Image: Internal Hex
		10mm	TS3M3510S
		11.5mm	TS3M3511S
		13mm	TS3M3015S
	4.0 (4.2)	7mm	TS3S4007S	2.5(Regular)
		8.5mm	TS3S4008S
		10mm	TS3S4010S
		11.5mm	TS3S4011S
	4.5 (4.6)	13mm	TS3S4013S
		7mm	TS3S4507S
		8.5mm	TS3S4508S
		10mm	TS3S4510S
	5.0 (5.1)	11.5mm	TS3S4511S
		13mm	TS3S4513S
		7 mm	TS3S5007S
		8.5 mm	TS3S5008S
	10 mm	TS3S5010S
	11.5 mm	TS3S5011S
13 mm	TS3S5013S
6.0 (6.0)	7 mm	TS3S6007S		Image: Internal Spline
	8.5 mm	TS3S6008S
	10 mm	TS3S6010S
	11.5 mm	TS3S6011S
13 mm	TS3S6013S
7.0 (6.8)	7 mm	TS3S7007S
	8.5 mm	TS3S7008S
	10 mm	TS3S7010S
	11.5 mm	TS3S7011S
13 mm	TS3S7013S
AstraOsseoSpeedEV(K120414)	3.6	6mm	25221	3.6
		8mm	25222
		9mm	25223
		11mm	25224
		13mm	25225
		15mm	25226
		17mm	25227
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength (mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-Abutment Connection
	4.2	6mm	25231	4.2
		8mm	25232
		9mm	25233
		11mm	25234
		13mm	25235
		15mm	25236
		17mm	25237
	4.8	6mm	25241	4.8
		8mm	25242
		9mm	25243
		11mm	25244
		13mm	25245
		15mm	25246
		17mm	25247
	5.4	6mm	25251	5.4
		8mm	25252
		9mm	25253
		11mm	25254
		13mm	25255
		15mm	25256
	3.0	10.5mm	TLX3010	3.0
		12mm	TLX3012
		15mm	TLX3015
BioHorizonsTaperedInternal(K093321,K143022,K071638)	3.4	9mm	TLX3409	3.0
		10.5mm	TLX3410
		12mm	TLX3412
		15mm	TLX3415
	3.8	18mm	TLX3418	3.5
		9mm	TLX3809
		10.5mm	TLX3810
		12mm	TLX3812
		15mm	TLX3815
	4.6	18mm	TLX3818	4.5
		7.5mm	TLX4607
		9mm	TLX4609
		10.5mm	TLX4610
		12mm	TLX4612
ImplantSystem	ImplantBodyDiameter(mm)	ImplantLength (mm)	Model No.	ImplantPlatformDiameter(mm)	Type of Implant-Abutment Connection
	5.8	15mm	TLX4615	5.7
		18mm	TLX4618
		7.5mm	TLX5807
		9mm	TLX5809
		10.5mm	TLX5810
		12mm	TLX5812
		15mm	TLX5815
		18mm	TLX5818
	4.1	6mm	033.560S	Regular Neck(RN)	Internal octagon
		8mm	033.561S
		10mm	033.562S
		12mm	033.563S
		14mm	033.564S
StraumannTissue Level(K122855,K202942)	4.8	6mm	033.590S
		8mm	033.591S
		10mm	033.592S
		12mm	033.593S
		14mm	033.594S
	6.5	6mm	033.610S	Wide Neck(WN)
		8mm	033.611S
		10mm	033.612S
		12mm	033.613S

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Image /page/9/Picture/0 description: The image shows a logo with the word "ABUTMENT" in white letters on a blue background. The letters are stylized, with the "A" being larger than the other letters. Below the word "ABUTMENT" are the letters "ru" in a similar blue color and font. The "r" is designed to look like 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 a company called "Abutment.ru". The word "Abutment" is in a sans-serif font and is placed above the letters "ru", which are larger and stylized. To the left of the "ru" is a graphic that resembles a screw or implant, possibly indicating the company's focus on dental implants or related products. The logo is in a bright blue color.

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

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Image /page/11/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The bottom of the logo has a design that resembles the threads of a screw, also in blue.

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 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 (K203649)
Indications for Use	TruAbutment DS is a patient-specific CAD/CAM abutment, directlyconnected to endosseous dental implants and is intended for use as anaid in prosthetic rehabilitation. It is compatible with the followingsystems:Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mmAll digitally designed abutments and/or coping for use with theTruAbutment DS abutments are intended to be sent to aTruAbutment-validated milling center for manufacture.	TruAbutment DS is a patient-specific CAD/CAM abutment, directlyconnected to endosseous dental implants and is intended for use as an aid inprosthetic 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 theTruAbutment DS abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

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Image /page/12/Picture/0 description: The image contains the word "ABUTMENT" in a stylized font. The "A" in "ABUTMENT" is larger than the other letters and is connected to a graphic that resembles a screw. The letters "ru" are also larger than the other letters in the word and are connected to the screw graphic. The text and graphic are all in a light blue color.

Attributes	Proposed Device	Primary Predicate Device
Trade Name	TruAbutment DS	TruAbutment DS (K203649)
CAD DesignLimits	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): 5.2~~8.0Minimum wall thickness: 0.4Minimum and Maximum length of abutment post (length above theabutment 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-6AI-4V ELI	Ti-6AI-4V ELI
AbutmentSeat	Sits on Taper	Sits on Taper
Anatomical	Oral Cavity	Oral Cavity
Construction	Machined	Machined
Type ofRetention	Screw-retained to the implant. The prosthesis can be cement-retainedto the abutment.	Screw-retained to the implant. The prosthesis can be cement-retained to theabutment.
Attributes	Proposed Device	Predicate Device
Trade Name	TruBase	TruBase (K203649)
Indicationsfor Use	TruBase is a titanium component that is directly connected to endosseousdental implants to provide support for custom prosthetic restorations, suchas copings or crowns. It is indicated for screw-retained single tooth orcement-retained single tooth and bridge restorations. It is compatible withthe following systems:Osstem TSIII SA (K121995): 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) Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm BioHorizons Tapered Internal (K093321, K143022, K071638)3.0, 3.4, 3.8, 4.6, 5.8 mm Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm All digitally designed zirconia superstructure for use with TruBase areintended to be sent to a TruAbutment-validated milling center formanufacture.	TruBase is a titanium component that is directly connected toendosseous dental implants to provide support for patient-specificprosthetic restorations, such as copings or crowns. It is indicated fora screw-retained single tooth or cement-retained single tooth andbridge 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 theTruBase are intended to be sent to a TruAbutment-validatedmilling center for manufacture.
CAD DesignLimits	Maximum Angulation 0~~15°Maximum Cuff Height 0.5~~5mmMinimum Diameter Ø 5.0~ Ø 8.0mmMinimum Thickness 0.4mmMinimum Post Height 4~6mm	Maximum Angulation (°): 0~~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 4~6mm
Attributes	Proposed Device	Predicate Device
Trade Name	TruBase	TruBase (K203649)
		Minimum post height(mm): 4~6
Material ofAbutmentand Screw	Ti-6Al-4V ELI	Ti-6Al-4V ELI
Implant-to-AbutmentConnection(s)	Screw-retained to the implant. The prosthesis can be cement-retainedto the abutment.	Screw-retained to the implant. The prosthesis can be cement-retainedto the abutment.
Type ofRetention	Screw-retained.	Screw-retained
Material ofSuperstructure	InCoris Zi (K123664)	InCoris ZI (K123664)
Manufacturing processes	TruAbutment-validated milling center	TruAbutment-validated milling center
End-UserSterilization	Moist steam sterilization	Moist steam sterilization

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Image /page/13/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are in all caps, with the "A" slightly raised above the rest of the word. The letters are a light blue color. The bottom of the image has a jagged edge, resembling teeth.

TruBase

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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 written in white letters on a blue background. The letters "ru" are written in a larger font size and are also blue. The logo has a stylized image of a screw on the left side of the letters "ru".

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Image /page/15/Picture/0 description: The image shows a logo with the word "ABUTMENT" in white, with the letters slightly overlapping each other. Below the word "ABUTMENT" is the letter "ru" in a larger font size and in the same color as the background. To the left of the letter "r" is a graphic of a screw.

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 (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 and the implant platform diameter. The following subject device (TruBase) is substantially equivalent in indications and design principles to the primary predicate device(K203649) listed above. The subject device (TruBase) and the primary predicate device(K203649) have internal implant interface connections and are made of Ti-6AI-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 fatigue testing. The fatigue limit data for all other implant lines demonstrated the construct strengths to their intended use.

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Image /page/16/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is primarily blue and features the word "Abutment" in a stylized font. Below the word "Abutment" is a graphic that resembles a tooth with a screw-like design, also in blue. The overall design is simple and modern.

Non-clinical Testing

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

Fatigue Test according to ISO 14801:2016 ●
Below tests were performed for predicate device (K203649) 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.

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

Conclusion

The TruAbutment DS, TruBase constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. 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.)

Indications for Use

Indications for Use (Describe)

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Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

510(k) Summary K213961

Official Correspondent

Device Information

Predicate Devices/ Reference Devices:

Primary Predicate:

Reference Devices for OEM Compatibilities:

General Description

TruAbutment DS

TruBase

Raw material blanks

Cement

Design Limitation for Zirconia superstructure

Indication for Use

TruAbutment DS

TruBase

TruAbutment DS and TruBase are compatible with the following devices:

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

Summary of Technological Characteristics

TruAbutment DS

TruBase

Substantial Equivalence Discussion

Non-clinical Testing

Conclusion

§ 872.3630 Endosseous dental implant abutment.

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

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