Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a CAD/CAM system for designing and manufacturing patient-specific dental abutments and bases. While it uses digital design and manufacturing, there is no mention of AI or ML being used in the design process or any other aspect of the device's function. The focus is on compatibility with existing implant systems and mechanical performance testing.

Therapeutic

Yes.
The device, an abutment for dental implants, is intended for prosthetic rehabilitation and provides support for custom prosthetic restorations, which is a therapeutic function.

Diagnostic

No

Explanation: The provided text describes dental abutments (TruAbutment DS and TruBase S) which are prosthetic components used for dental implant rehabilitation, providing support for crowns or other restorations. Their intended use is to aid in prosthetic rehabilitation, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

No

The device description clearly states that the system includes patient-specific abutments and titanium components (TruBase S) which are physical hardware intended for implantation or connection to implants. While CAD/CAM design is mentioned, the final product is a manufactured physical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for prosthetic rehabilitation, specifically providing support for dental restorations connected to dental implants. This is a mechanical and structural function within the oral cavity.
Device Description: The device description details the materials and design of dental abutments and bases, which are physical components used in dental procedures.
Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a disease or condition, or to examine specimens derived from the human body for diagnostic purposes.
Anatomical Site: The device is used within the oral cavity, directly on the patient, not for testing samples outside the body.
Performance Studies: The performance studies focus on mechanical properties and compatibility with dental implants, not on diagnostic accuracy or analytical performance.

IVD devices are typically used to perform tests on samples like blood, urine, or tissue to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

N/A

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.)

Summary

0

March 03, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, and on the right, there is the FDA logo. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K201197

Trade/Device Name: TruAbutment DS, TruBase S Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: February 10, 2021 Received: February 23, 2021

Dear Chris Choi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be f ound 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation -emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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

Enclosure

2

Indications for Use

510(k) Number (if known) K201197

Device Name TruAbutment DS, TruBase S

Indications for Use (Describe)

TruAbutment DS

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

· Zimmer 3.1mmD Dental Implant System (K142082)

· Screw Vent® and Tapered Screw Vent® (K013227)
· Nobel Active 3.0 (K102436)
· Nobel Active Internal Connection Implant (K071370)

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.

TruAbutment DS is compatible with the following devices:

Zimmer 3.1mmD Dental Implant System(K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex

Screw Vent® and Tapered Screw Vent® (K013227) Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex Nobel Active 3.0 (K102436) Implant Body Diameter 3.0/ Implant Platform Diameter 3.0 / Internal Hex

Nobel Active Internal Connection Implant (K071370)

Implant Body Diameter 3.5/ Implant Platform Diameter NP / Internal Hex Implant Body Diameter 4.3/ Implant Platform Diameter RP / Internal Hex Implant Body Diameter 5.0/ Implant Platform Diameter RP / Internal Hex Implant Body Diameter 5.5/ Implant Platform Diameter WP / Internal Hex Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

3

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.

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

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

4

Indications for Use

510(k) Number (if known) K201197

Device Name TruAbutment DS, TruBase S

Indications for Use (Describe)

TruBase S

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

· Zimmer 3.1mmD Dental Implant System (K142082)

· Screw Vent® and Tapered Screw Vent® (K013227)
TruBase S is intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase S is compatible with the following devices:

Zimmer 3.1mmD Dental Implant System(K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex

Screw Vent® and Tapered Screw Vent® (K013227) Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex

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.

5

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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

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

6

Image /page/6/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in a smaller font size and is placed above the word "ru". The "A" in "Abutment" is capitalized, while the rest of the letters are in lowercase. The word "ru" is in a larger font size and is in lowercase. To the left of the word "ru" is a graphic of a screw.

510(k) Summary K201197

Submitter

TruAbutment Inc. Eunjin Jang 17742 Cowan, Irvine, CA 92614 USA Email: Eunjin.jang@truabutment.com Phone: 1-714-956-1488

Official Correspondent

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

Device Information

Trade Name: TruAbutment DS, ● TruBase S
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: 03/24/2021 ●

Predicate Devices/ Reference Devices:

Predicate Devices:

TruAbutment DS (K170259) by TruAbutment Inc. TruBase S (K171532) by TruAbutment Inc.

Reference Devices:

Zimmer 3.1mmD Dental Implant System (K142082) by Zimmer Dental, Inc.

Screw Vent® and Tapered Screw Vent® (K013227) by Sulzer Dental Inc.

Nobel Active 3.0 (K102436) by Nobel Biocare.

Nobel Active Internal Connection Implant (K071370) by Nobel Biocare.

Dess Dental Smart Solution (K170588) by Terrats Medical SL

InCoris Zi (K123664) by Sirona Dental Systems GmbH.

3shape Abutment Designer Software (K151455) by 3Shape A/S.

RelyX Unicem 2Automix (K100756) by 3M ESPE

TruAbutment DS (K172304) by TruAbutment Inc.

TruAbutment DS (K152559) by TruAbutment Inc.

URIS OMNI Narrow System & Prosthetic (K200817) by TruAbutment Inc.

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Image /page/7/Picture/0 description: The image shows a logo for "Abutment ru". The logo is primarily blue and white. The word "Abutment" is written in white letters on a blue background. Below the word "Abutment" are the letters "ru" in a stylized font, also in blue. To the left of the letters "ru" is a graphic that resembles a screw.

General Description

TruAbutment DS

TruAbutment DS system includes patient-specific abutments that are placed into the dental implant to provide support for prosthetic restoration. The subject abutments are indicated for cemented or screwretained restorations. The patient-specific abutment screws 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 the 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 proposed abutments are available in internal hex connection, and are compatible with the following systems:

· Zimmer 3.1mmD Dental Implant System (K142082)
· Screw Vent® and Tapered Screw Vent® (K013227)
· Nobel Active 3.0(K102436)
· Nobel Active Internal Connection Implant (K071370)

Design Limitation for TruAbutment DS

Design parameter	Design Limit
Minimum and Maximum abutment angle	0~25°
Minimum and Maximum Cuff Height	0.5~6.0mm
Minimum and Maximum diameter at
abutment/implant interface	$\varnothing$ 3.5mm~ $\varnothing$ 8.0mm
Minimum Thickness	0.4 mm
Minimum and Maximum length of
abutment post (length above the abutment
collar/gingival height)	4 ~7 mm

TruBase S

TruBase S consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment.

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Image /page/8/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is in blue and white. The word "Abutment" is in a sans-serif font, and the letters are capitalized. The letters "ru" are in a larger, bolder font and are placed below the word "Abutment". To the left of the letters "ru" is a graphic of a screw.

TruBase S abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (Zimmer 3.1mmD Dental Implant System: 2.9mm and Screw Vent® and Tapered Screw Vent®: 3.5, 4.5, 5.7mm). They also feature:

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

CAD/CAM customized superstructure that composes the final 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 S in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

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

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

| TruAbutment
Platform Diameter
/ Compatible
Implant System | TruAbutment DS
Engaging | TruAbutment DS
Non-Engaging | TruBase S
Engaging | TruBase S
Non-Engaging |
|--------------------------------------------------------------------|----------------------------|--------------------------------|-----------------------|---------------------------|
| Zimmer 3.1mmD | | | | |
| 2.9 | O | O | O | O |
| Screw Vent® and
Tapered Screw
Vent® | | | | |
| 3.5 | X | O | O | O |
| 4.5 | X | O | O | O |
| 5.7 | X | O | O | O |
| NobelActive 3.0 | | | | |
| 3.0 | O | O | X | X |
| Nobel Active
Internal | | | | |
| NP | X | O | X | X |
| RP | X | O | X | X |
| WP | X | O | X | X |

X: Not included in this submission

O: Included in this submission

9

Image /page/9/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The "A" in "ABUTMENT" is larger than the other letters and is positioned slightly above the rest of the word. Below "ABUTMENT" is a stylized image that resembles a tooth implant. The logo is in a bright blue color.

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 at
abutment/implant interface	$\varnothing$ 5.0mm~ $\varnothing$ 8.0mm
Minimum Thickness	0.4 mm
Minimum and Maximum length of
abutment post (length above the abutment
collar/gingival height)	4~6 mm

Indication for Use

TruAbutment DS

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

Zimmer 3.1mmD Dental Implant System (K142082)
. Screw Vent® and Tapered Screw Vent® (K013227)
Nobel Active 3.0 (K102436) ●
. Nobel Active Internal Connection Implant (K071370)

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.

TruAbutment DS is compatible with the following devices:

Zimmer 3.1mmD Dental Implant System(K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex

Screw Vent® and Tapered Screw Vent® (K013227) Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex

Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex

Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex

Nobel Active 3.0 (K102436)

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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 white. The word "Abutment" is written in a sans-serif font, with the "A" being larger than the rest of the letters. Below "Abutment" is the text "ru" in a larger, stylized font. To the left of the "ru" text is a graphic that resembles the side view of a tooth.

Implant Body Diameter 3.0/ Implant Platform Diameter 3.0 / Internal Hex

Nobel Active Internal Connection Implant (K071370) Implant Body Diameter 3.5/ Implant Platform Diameter NP / Internal Hex Implant Body Diameter 4.3/ Implant Platform Diameter RP / Internal Hex Implant Body Diameter 5.0/ Implant Platform Diameter RP / Internal Hex Implant Body Diameter 5.5/ Implant Platform Diameter WP / Internal Hex

TruBase S

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

. Zimmer 3.1mmD Dental Implant System (K142082)
. Screw Vent® and Tapered Screw Vent® (K013227)

TruBase S is intended to be sent to a TruAbutment-validated milling center for manufacture.

TruBase S is compatible with the following devices:

Zimmer 3.1mmD Dental Implant System(K142082) Implant Body Diameter 3.1/ Implant Platform Diameter 2.9 / Internal Hex

Screw Vent® and Tapered Screw Vent® (K013227) Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex

11

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 stylized font at the top. Below "ABUTMENT", the letters "ru" are displayed in a larger, bolder font, with a graphic resembling a screw or bolt head integrated into the design on the left side of the letters. The overall design is clean and modern, suggesting a company involved in engineering or construction.

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

| Implant System Body
Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment
Connection |
|----------------------------------------------------------------| | Zimmer
3.1mmD Dental
Implant System
( and Tapered
Screw Vent®
( 3.0
( Internal
Connection
Implant
( Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment
Connection |
| | | | | | | | | | | | 5.0 | | | | | | | | | | | | 5.5 | | | | | | | | | | | Implant
-------------------------------------|------------------------|-----------|-----------------------------------------|--------------------------------------------|
rel="noopener noreferrer" class="text-primary hover:underline break-words">K142082) | 3.1 | 8mm | CM318 | 2.9 | Internal Hex |
| 10mm | CM3110 | | |
| 11.5mm | CM3111 | | |
| 13mm | CM3113 | | |
| 16mm | CM3116 | | |
| TSVTB8 | 3.5 | Internal Hex | |
| 10mm | TSVTB10 | | | |
| 11.5mm | TSVTB11 | | | |
| 13mm | TSVTB13 | | | |
| 16mm | TSVTB16 | | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K013227) | 4.1 | 8mm | | | TSVT4B8 |
| 10mm | | | TSVT4B10 |
| 11.5mm | | | TSVT4B11 |
| 13mm | | | TSVT4B13 |
| 16mm | | | TSVT4B16 |
| 4.7 | | | 8mm |
| TSVTWB10 | | 5.7 | Internal Hex | |
| TSVTWB11 | | | | |
| TSVTWB13 | | | | |
| TSVTWB16 | | | | |
| TSVT6B8 | | | |
| 10mm | TSVT6B10 | | | |
| 11.5mm | TSVT6B11 | | | |
| 13mm | TSVT6B13 | | | |
| 16mm | TSVT6B16 | | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K102436) | 3.0 | 10mm | | | 36769 |
| 11.5mm | 36770 | | |
| 13mm | 36771 | | |
| 15mm | 36772 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K071370) | 3.5 | 8.5mm | 35221 | NP | Internal Hex |
| 10mm | 34125 | | |
| 11.5mm | 34126 | | |
| 13mm | 34127 | | |
| 15mm | 34128 | | |
| 18mm | 35215 | | |
| 8.5mm | 35223 | RP | |
| Implant
| 10mm | 34131 | | |
| 11.5mm | 34132 | | |
| 13mm | 34133 | | |
| 15mm | 34134 | | |
| 18mm | 35219 | | |
| 8.5mm | 35225 | RP | |
| 10mm | 34137 | | |
| 11.5mm | 34138 | | |
| 13mm | 34139 | | |
| 15mm | 34140 | | |
| 18mm | 35220 | | |
| 7mm | 37806 | WP | |
| 8.5mm | 37807 | | |
| 10mm | 37808 | | |
| 11.5mm | 37809 | | |
| 13mm | 37810 | | |
| 15mm | 37811 | | |

12

Image /page/12/Picture/0 description: The image shows a logo for a company called "Abutment". The word "Abutment" is written in a stylized font, with the letters "ru" in a larger font size and a different color. The logo is primarily blue and white.

TruAbutment Inc. 17742 Cowan, Irvine, CA 92614

13

Image /page/13/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The logo is blue and has a design that resembles a screw or bolt. The letter "A" in "ABUTMENT" is larger than the other letters. The logo appears to be for a company or product related to dental implants or other medical devices.

Summary of Technological Characteristics

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

TruAbutment DS

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Image /page/14/Picture/0 description: The image shows a logo for "Abutment.ru". The logo is in blue and features the word "Abutment" in a sans-serif font, with the "A" slightly larger than the other letters. Below "Abutment" is the text ".ru" in a larger, stylized font. To the left of the text is a graphic that resembles a screw.

| to be sent to a
TruAbutment-validated
milling center for
manufacture.

TruAbutment DS is
compatible with the
following devices:

Zimmer 3.1mmD Dental
Implant System(K142082)
Implant Body Diameter
3.1/ Implant Platform
Diameter 2.9 / Internal Hex

Screw Vent® and Tapered
Screw Vent® (K013227)
Implant Body Diameter
3.7/ Implant Platform
Diameter 3.5 / Internal Hex
Implant Body Diameter
4.1/ Implant Platform
Diameter 3.5 / Internal Hex
Implant Body Diameter
4.7/ Implant Platform
Diameter 4.5 / Internal Hex
Implant Body Diameter
6.0/ Implant Platform
Diameter 5.7 / Internal Hex

Nobel Active 3.0
(K102436)
Implant Body Diameter
3.0/ Implant Platform | Contour Abutment and the
2.9mm Contour Abutment,
Straight Hex are used as a
terminal or intermediate
abutment for a cemented
prosthesis. Abutment can be
used for a single- or multiple-
unit restoration. The 2.9mm
Angled Contour Abutment
and the 2.9mm Angled
Contour Abutment, Straight
Hex are designed to be used
as a terminal or intermediate
abutment for a cemented
prosthesis where the angle
needs to be offset by 17°.
Abutment can be used for a
single- or multiple-unit
restoration. | |

---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	--

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Image /page/15/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The first letter "A" is larger than the other letters, and the word is slightly slanted to the right.

| | Diameter 3.0 / Internal Hex

Nobel Active Internal
Connection Implant
(K071370)
Implant Body Diameter
3.5/ Implant Platform
Diameter NP / Internal Hex
Implant Body Diameter
4.3/ Implant Platform
Diameter RP / Internal Hex
Implant Body Diameter
5.0/ Implant Platform
Diameter RP / Internal Hex
Implant Body Diameter
5.5/ Implant Platform
Diameter WP / Internal
Hex | | | |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Connection | Internal Hex | Internal Hex | Internal Hex | same |
| Sterility | Packaged Non-sterile | Packaged Non-sterile | Packaged Non-sterile | same |
| Material | Ti-6Al-4V ELI | Ti-6Al-4V ELI | Titanium 6Al-4V ELI | same |
| Abutment
Angle ° | 025 ° | 025° | 20 ° | Similar, the angulation (0~25°
is broader than the reference
device. |
| Abutment Seat | Sits on Taper | Sits on Taper | Sits on Taper | same |
| Anatomical | Oral Cavity | Oral Cavity | Oral Cavity | same |
| Construction | Machined | Machined | Machined | same |
| Type of
Retention | Screw-retained to the implant.
The prosthesis can be cement-
retained to the abutment. | Screw-retained to the implant.
The prosthesis can be cement-
retained to the abutment. | Screw-retained to the implant.
The prosthesis can be cement-
retained to the abutment. | same |

16

Image /page/16/Picture/0 description: The image contains the word "ABUTMENT" in a stylized font. The word is in all caps, with the "A" slightly raised above the rest of the letters. The letters are a light blue color. The bottom of the image has a jagged edge, resembling the teeth of a gear.

TruBase S

Attributes	Proposed Device	Predicate Device	Reference Device
Trade Name	TruBase S (K201197)	TruBase S (K171532)	Dess Dental Smart
Solution (K170588)
Indications for Use	TruBase S is a titanium
component that is
directly connected to
endosseous dental
implants to provide
support for custom
prosthetic restorations,
such as copings or
crowns. It is indicated
for screw-retained single
tooth or cement-retained
single tooth and bridge
restorations. It is
compatible with the
following systems:
Zimmer 3.1mmD Dental
Implant System
(K142082)
Screw Vent® and
Tapered Screw Vent®
(K013227)
TruBase S is intended to
be sent to a	TruBase S is a titanium
component that is
directly connected to
endosseous dental
implants to provide
support for custom
prosthetic restorations,
such as copings or
crowns. It is indicated
for screw-retained single
tooth or cement-retained
single tooth and bridge
restorations. It is
compatible with the
following systems:
Zimmer TSV - 3.7, 4.1,
4.7, 6.0 mm
All digitally designed
abutments and/or coping
for use with the TruBase
S are to be designed
using Sirona inLab
software or Sirona
CEREC Software and
manufactured using a
Sirona CEREC or inLab
MCX or MC XL milling
unit.	Dess Dental Smart
Solutions abutments
are intended to be used
in conjunction with
endosseous dental
implants in the
maxillary or
mandibular arch to
provide support for
prosthetic restorations.
All digitally designed
custom abutments for
use with TiBase or Pre-
milled Blank are to be
sent to Terrats Medical
validated milling center
for manufacture.
Compatible Implant
System
3i Certain 3.25,4.0,5.0
(3.4,4.1,5.0 Platform
Diameter)
3i OSSEOTITE
3.25,3.75,4.0,5.0
(3.4,4.1,5.0)
Osseo Speed 3.5,4.0,5.0
(3.5/4.0, 4.5/5.0)
FRIADENT Xive
3.4,3.8,4.5
(3.4, 3.8, 4.5)
Nobel Active 3.5,4.3,5.0	Equivalent
Similar to a predicate
device and reference
device, both are
indicated for single or
multiple prosthesis of
partially or completely
edentulous jaws. Both
are intended for
surgical placement in
the upper or lower jaw.
The subject devices are
compatible with the
same CAD/CAM
System as the predicate
device.

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Image /page/17/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The "A" is larger than the other letters, and the "T" is stylized to look like a screw. The text is in a light blue color.

| TruAbutment-validated
milling center for
manufacture.

TruBase S is compatible
with the following
devices:

Zimmer 3.1mmD
Dental Implant
System(K142082)
Implant Body
Diameter 3.1/ Implant
Platform Diameter 2.9 /
Internal Hex

Screw Vent® and
Tapered Screw Vent®
(K013227)
Implant Body
Diameter 3.7/ Implant
Platform Diameter 3.5/
Internal Hex

Implant Body
Diameter 4.1/ Implant
Platform Diameter 3.5/
Internal Hex

Implant Body
Diameter 4.7/ Implant | (NP,RP)
Nobel Replace Conical
3.5,4.3,5 (NP,RP)
Nobel Replace Trilobe
3.5,4.3,5.0
(NP,RP,WP)
BraneMark
3.5,3.75/4.0,5.0(NP,RP,WP)
Straumann Bone Level
3.3,4.1,4.8
(NC,RC)
Straumann Tissue Level
3.3,4.1,4.8 (RN, WN)
Zimmer Tapered Screw
Vent 3.7,4.1,4.7,6.0
(3.5,4.5,5.7) |

--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

18

Image /page/18/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The "A" in "ABUTMENT" is larger than the other letters and is positioned slightly above the rest of the word. The logo is blue and has a design that resembles a screw or bolt on the left side of the word.

| Platform Diameter 4.5 /

Internal Hex
Implant Body
Diameter 6.0/ Implant
Platform Diameter 5.7 /
Internal Hex
Abutment Diameter(s)	Engaging: 3.5, 3.8, 4.5,
5.7mm
Non-Engaging: 3.5, 4.3,
4.5, 5.3, 5.7, 6.5mm	Engaging: 4.3, 5.3, 6.5mm	3.4~6.5mm	Similar, Angulation is
within the
range of the reference
device.
Abutment Height(s)	4.7mm	4.7mm	Not stated in 510(k)
summary	same
Material of Abutment	Ti-6Al-4V ELI	Ti-6Al-4V ELI	Ti-6Al-4V alloy	same
Implant-to-Abutment
Connection(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.	Screw-retained to the
implant. The prosthesis can
be cement-retained to the
abutment.	same
Type of Retention	Screw-retained.	Screw-retained	Screw-retained	same
Restorative Range
of Angulation	Up to 15°	Up to 20°	Straight (0°)	Similar, Angulation is
within the
range of the predicate
device.
Material of
Superstructure	InCoris Zi (K123664)	InCoris ZI (K123664)	Not stated in 510(k)
summary	same
Patient-Specific Design	CAD/CAM manufactured
superstructures	CAD/CAM manufactured
superstructures	CAD/CAM manufactured
superstructures	same
End-User Sterilization	Moist steam sterilization	Moist steam sterilization	Moist steam sterilization	same

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Image /page/19/Picture/0 description: The image is a logo for Abutment.ru. The logo is 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."

Substantial Equivalence Discussion

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

The Indications for Use Statement (IFUS) for subject device (TruAbutment DS) is substantially equivalent in intended use to the predicate device (K170259), and the reference devices (K142082). All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible.

The minor differences between the IFUS for the subject device (TruAbutment DS) and the predicate(K170259) include:

Although the predicate device (K170259) is compatible with Screw Vent® and Tapered Screw Vent® K013227, the subject device (TruAbutment DS) is compatible with, not only Screw Vent® and Tapered Screw Vent® K013227 but also Zimmer 3.1mmD Dental Implant System K142082, Nobel Active 3.0 K102436 and Nobel Active Internal Connection Implant K071370.

The difference between the two products in the design parameters are the same except for the minimum diameter. The minimum diameter of the product compatible with the subject device Zimmer 3.1mmD Dental Implant System K142082 is smaller than K170259.

| Design parameter | Subject Device
Design Limit | Predicate Device
(K170259)
Design Limit |
|------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------------------|
| Minimum and Maximum abutment
angle | 0~~25° | 0~~25° |
| Minimum and Maximum Cuff
Height | 0.5~ 6.0mm | 0.5~ 6.0mm |
| Minimum and Maximum diameter
at abutment/implant interface | Ø3.5mm~~Ø8.0mm | Ø4.0mm~~Ø8.0mm |
| Minimum Thickness | 0.4 mm | 0.4 mm |
| Minimum and Maximum length of
abutment post (length above the
abutment collar/gingival height) | 4 ~7 mm | 4 ~7 mm |

20

Image /page/20/Picture/0 description: The image shows a logo for "Abutmentru". The logo is in blue and features a stylized letter "A" with the word "BUTMENT" in smaller letters above it. The letter "A" is designed to resemble a dental implant. The rest of the logo is a stylized "ru".

This submission includes Screw Vent® and Tapered Screw Vent® K013227, Nobel Active 3.0 K102436 and Nobel Active Internal Connection Implant K071370 compatible Non-Engaging products. These products are all identical except for the connection type in the previously cleared K170259 and K172304.

TruAbutment DS compatible with Screw Vent® and Tapered Screw Vent®
Engaging	Non-Engaging
K170259	Subject device
has cleared with K170259 (in prior 510k submission)

No other Modification (e.g. Coating Change, Manufacturing Process, Material, etc)

TruAbutment DS compatible with Nobel Active Internal Connection Implant
Engaging	Non-Engaging
K172304	Subject device
has cleared with K172304 (in prior 510k submission)

| No other Modification (e.g. Coating Change, Manufacturing Process, Material, etc)

(K172304: TruAbutment DS compatible with Astra Tech OsseoSpeed™ EV, Nobel Active™ Internal Connection Implant, Straumann® Bone Level Implants)

The Indications for Use Statement (IFUS) for subject device (TruBase S) is substantially equivalent in intended use to the predicate device (K171532), and the reference devices (K170588). All are intended for use with endosseous dental implants in the maxilla and mandible to provide functional and esthetic rehabilitation of the edentulous maxilla and mandible. The subject device and the predicate device have same material (Ti-6A1-4V ELI). compatible OEM Implant line, validated milling center.

The minor differences between the IFUS for the subject device and the predicate device is angulation and software.

The difference between the two products in the design parameters are the same except for the minimum diameter. The minimum diameter of the product compatible with the subject device Zimmer 3.1mmD Dental Implant System K142082 is smaller than K171532. The angle of predicate device K171532 is 20°, while the subject device (TruBase S) can be designed up to 15°

| Design parameter | Subject Device
Design Limit | Predicate Device
(K171532)
Design Limit |
|---------------------------------------|--------------------------------|-----------------------------------------------|
| Minimum and Maximum abutment
angle | 0~~15° | 0~~20° |
| Minimum and Maximum Cuff
Height | 0.5~~5 mm | 0.5~~5 mm |

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Image /page/21/Picture/0 description: The image is a logo for Abutment. The logo is blue and white. The word "Abutment" is written in white letters on a blue background. The rest of the logo is blue and looks like a screw.

| Design parameter | Subject Device
Design Limit | Predicate Device
(K171532)
Design Limit |
|------------------------------------------------------------------------------------------------------|--------------------------------|-----------------------------------------------|
| Minimum and Maximum diameter
at abutment/implant interface | Ø5.0mm~~Ø8.0mm | Ø6.0mm~~Ø8.0mm |
| Minimum Thickness | 0.4 mm | 0.4 mm |
| Minimum and Maximum length of
abutment post (length above the
abutment collar/gingival height) | 4 ~6 mm | 4 ~6 mm |

This submission includes Screw Vent® and Tapered Screw Vent® K013227 compatible Non-Engaging products. These products are all identical except for the connection type in the previously cleared K171532.

TruBase S compatible with Tapered Screw Vent®
Engaging	Non-Engaging
K171532	Subject device
has cleared with K171532 (in prior 510k submission)
No other Modification (e.g. Coating Change, Manufacturing Process, Material, etc)

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

Non-clinical Testing

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

. Fatigue Test according to ISO 14801:2016
Below tests is leveraged from previous 510k (K152559):
· End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
· Biocompatibility testing for cytotoxicity, Intracutaneous Reactivity and Sensitization according to ISO 10993-5:2009 "Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity", ISO 10993-10:2010 "Part 10: Tests for irritation and skin sensitization" and ISO 10993-10:2010 "Chapter 9 Murine Local Lymph Node Assay".

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.

Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous

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Image /page/22/Picture/0 description: The image is a logo for Abutment. The logo is blue and white. The word "Abutment" is in white letters with a blue outline. The letters "ru" are in large blue font below the word "Abutment."

Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, (smallest diameter with maximum angulation) through fatigue testing.

Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible implant body as well as the OEM implant abutment and implant body. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.

Conclusion

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