Predicate Devices

Reference Devices

K120414, K130999, K041368, K192221, K140091, K163194, K102436, K071370, K133731, K121995, K173961, K181703, K191256, K162890, K140878, K142082, K013227

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use indicate a mechanical dental abutment and its components, with no mention of software, algorithms, or data processing that would suggest AI/ML. The performance studies are mechanical tests.

Therapeutic

Yes
The device, an abutment for dental implants, is intended to support multiple-unit restorations in partially or fully edentulous mandibles and maxillae, thereby treating or alleviating a condition (edentulism) by restoring function.

Diagnostic

No

This device is an abutment for dental implants, intended to support prosthetics. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states the abutments are made of Titanium and are physical components placed into dental implants. This indicates a hardware device, not software only.

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 to provide support for prosthetic restorations in the mouth, specifically in conjunction with dental implants. This is a mechanical function within the body.
Device Description: The device is described as abutments made of titanium, which are physical components used in dental procedures.
Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
Anatomical Site: The device is used within the body (mandibles and maxillae). IVDs typically analyze samples taken from the body.
Performance Studies: The performance studies focus on mechanical testing (fatigue testing), which is relevant to the structural integrity of a dental device, not a diagnostic test.

In vitro diagnostics are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device clearly falls outside of that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

AOT & T-L Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations.

It is compatible with the following systems:

Astra OsseoSpeed EV(K130999) 3.0
Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
Dentium Company Limited Implantium (K041368) 3.6, 4.0, 4.5, 5.0 (Regular)
Implant Direct Legacy2(K192221) 3.0
Megagen AnyRidge Internal Implant System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4 (3.1)
Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
Nobel Active 3.0 (K102436) 3.0
Nobel Active Internal Connection Implant (K071370) NP RP 3.5, 4.3, 5.0
Nobelactive Wide Platform (Wp) (K133731) WP 5.5
TS Fixture System (K121995) 3.5 (3.75) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) mm (Mini, Regular)
Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.1(3.5), 4.7(4.5), 6.0(5.7)

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

AOT & T-L Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). AOT abutment is a straight multi-unit abutment that connect implant fixtures to a restoration, such as a dental bridge or a denture. AOT products includes abutments and components (AOT Base, AOT Temporary, AOT Base Screw, AOT Plus Screw). T-L abutment is for partial and full arch restorations on endosseous dental implants. AOT & T-L abutments are provided in various gingival cuff height ranging from 1 to 3 mm for AOT , 1 to 6 mm for T-L.

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 AOT & T-L Abutment 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

mandibles and maxillae

Indicated Patient Age Range

Not Found

Intended User / Care Setting

authorized healthcare provider

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Testing:

Fatigue Test according to ISO 14801:2016
End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010. (Leveraged from predicate K152559, K200817)
Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010. (Leveraged from predicate K152559, K200817)

Key Results:

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.
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 be substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

URIS OMNI Narrow Implant System (K200817)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Astra OsseoSpeed EV (K120414, K130999), Dentium Company Limited Implantium (K041368), Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts (K192221), Xpeed AnyRidge Internal Implant System (K140091), Neodent Implant System - GM Helix (K163194), Nobelactive 3.0 (K102436), Nobelactive Internal Connection Implant (K071370), Nobelactive Wide Platform (Wp) (K133731), TS Fixture System (K121995), Straumann BLX Implant System (K173961), Straumann BLX Line Extension - Implants (K181703), Straumann BLX Ø 3.5 Mm Implants (K191256), Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890), Straumann® Bone Level Tapered Implants (K140878), Zimmer 3.1mmD Dental Implant System (K142082), Screw Vent® and Tapered Screw Vent® (K013227)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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

Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. 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 Kim Manager 17666 Fitch Irvine, California 92614

Re: K231874

Trade/Device Name: AOT & T-L Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: September 29, 2023 Received: October 2, 2023

Dear Chris Kim:

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.

1

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

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).

Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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.

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.

2

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

3

Indications for Use

510(k) Number (if known) K231874

Device Name AOT & T-L Abutment

Indications for Use (Describe)

AOT & T-L Abutment is intended for use in conjunction with the fixture in partially or fully edentulous and maxillae, in support of multiple-unit restorations.

It is compatible with the following systems:

· Astra OsseoSpeed EV(K130999) 3.0
· Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
· Dentium Company Limited Implantium (K041368) 3.6, 4.0, 4.5, 5.0 (Regular)
· Implant Direct Legacy2(K192221) 3.0
· Megagen AnyRidge Internal Implant System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4 (3.1)
· Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
· Nobel Active 3.0 (K102436) 3.0
· Nobel Active Internal Connection Implant (K071370) NP RP 3.5, 4.3, 5.0
· Nobelactive Wide Platform (Wp) (K133731) WP 5.5
· TS Fixture System (K121995) 3.5 (3.75) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) mm (Mini, Regular)
· Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
· Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
· Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
· Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.1(3.5), 4.7(4.5), 6.0(5.7)

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)

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Image /page/4/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The "A" is larger than the other letters, and the word is in all caps. Below the word "ABUTMENT" is the letters "ru" in a stylized font. The logo is a light blue color.

510(k) Summary K231874

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 Kim 17666 Fitch, Irvine, CA 92614 USA Email: chris.kim@truabutment.com Phone: 1-714-956-1488

Device Information

Trade Name: AOT & T-L Abutment ●
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: 10/30/23 ●

Predicate Devices/ Reference Devices:

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

Primary Predicate:

. URIS OMNI Narrow Implant System (K200817) by TruAbutment Inc.

Reference Devices for OEM Compatibilities:

Astra OsseoSpeed EV (K120414, K130999) by Astra. ●
Dentium Company Limited Implantium (K041368) by Dentium Co., LTD. .
Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, ● Legacy4 fixture-mounts (K192221) by Implant Direct LLC
Xpeed AnyRidge Internal Implant System (K140091) by Megagen Implant Co., LTD. ●
Neodent Implant System - GM Helix (K163194) by Straumann USA, LLC.
. Nobelactive 3.0 (K102436) By Nobel Biocare.
Nobelactive Internal Connection Implant (K071370) By Nobel Biocare.
Nobelactive Wide Platform (Wp) (K133731) By Nobel Biocare. ●
. TS Fixture System (K121995) by Osstem Implant Co., Ltd.

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Image /page/5/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 large blue letters below the word "Abutment."

Straumann BLX Implant System (K173961) by Straumann USA, LLC.
Straumann BLX Line Extension - Implants (K181703) by Straumann USA, LLC.
Straumann BLX Ø 3.5 Mm Implants (K191256) by Straumann USA, LLC
Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) by . Straumann USA, LLC.
. Straumann® Bone Level Tapered Implants (K140878) by Straumann USA, LLC.
Zimmer 3.1mmD Dental Implant System (K142082) by Zimmer Dental, Inc.
Screw Vent® and Tapered Screw Vent® (K013227) by Sulzer Dental Inc. ●

General Description

AOT & T-L Abutment

AOT & T-L Abutment which are placed into the dental implant to provide support for the prosthetic restoration. The abutments are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). AOT abutment is a straight multi-unit abutment that connect implant fixtures to a restoration, such as a dental bridge or a denture. AOT products includes abutments and components (AOT Base, AOT Temporary, AOT Base Screw, AOT Plus Screw). T-L abutment is for partial and full arch restorations on endosseous dental implants. AOT & T-L abutments are provided in various gingival cuff height ranging from 1 to 3 mm for AOT , 1 to 6 mm for T-L.

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 AOT & T-L Abutment 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.

6

Image /page/6/Picture/0 description: The image shows a logo for "Abutment ru". The logo is in a sans-serif font and is a light blue color. The "A" in "Abutment" is larger than the other letters, and the "ru" is in a cursive font and is connected to the "t" in "Abutment". The bottom of the logo has a jagged edge, resembling a screw.

Indication for Use

AOT & T-L Abutment

AOT & T-L Abutment is intended for use in conjunction with the fixture in partially or fully edentulous mandibles and maxillae, in support of multiple-unit restorations.

It is compatible with the following systems:

· Astra OsseoSpeed EV(K130999) 3.0
· Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
· Dentium Company Limited Implantium (K041368): 3.6, 4.0, 4.5, 5.0 (Regular)
· Implant Direct Legacy2(K192221) 3.0
· Megagen AnyRidge Internal Implant System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4 (3.1)
Neodent Implant System GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
· Nobel Active 3.0 (K102436) 3.0
· Nobel Active Internal Connection Implant (K071370) NP RP 3.5, 4.3, 5.0
· Nobelactive Wide Platform (Wp) (K133731) WP 5.5
· TS Fixture System (K121995) 3.5 (3.75), 4.0 (4.2), 4.5 (4.6) , 5.0 (5.1) mm (Mini, Regular)
Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
· Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
· Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
· Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
· Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.1(3.5), 4.7(4.5), 6.0(5.7)

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Image /page/7/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The bottom of the image has a jagged edge that resembles the teeth of a gear or saw blade.

AOT & T-L Abutment are compatible with the following devices:

| Implant
System | Implant
Body
Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
|--------------------------------------------------------------| | Astra
OsseoSpeed
EV
( OsseoSpeed
EV
( SuperLine
( System | Implant
Body
Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
| | 4.0 | | | | | | | | 4.5 | | | | | | | | 5.0 | | | | | | | Implant
Direct
Legacy
( AnyRidge
( System | Implant
Body
Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
| | 4.9 | | | | | | | | | | | | | | 5.4 | | | | | | | | | | | | | | 3.5 | | | | | | | | | | | Neodent GM
( System | Implant
Body
Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
| | 5.0 | | | | | | | | | | | | | | 6.0 | | | | | | | | | | 3.0 | | | | | | | | 3.5 (NP) | | | | | | | | NobelActive
( ( System | Implant
Body
Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
| Straumann BLX
( System | Implant
Body
Diameter
(mm) | Implant
Length (mm) | Model No. | Implant
Platform
Diameter
(mm) | Type of Implant-
Abutment Connection |
| | 5.0 (WB) | | | | | | | | | | | | | | | | | | | 5.5 | | | | | | | | 6.5 | | | | | | | Straumann
Bone Level
Implants
SC
( (SC) | | | | | | | 3.3 Crossfit
(NC) | | | | | | | | | | | | Straumann
Bone Level
Implants
NC, RC
( (RC) | | | | | | | | | | | | | 4.8 | | | | | | | Implant
System | Implant
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®
( rel="noopener noreferrer" class="text-primary hover:underline break-words">K130999) | 3.0 | 8mm | 25212 | 3.0 | Image: Implant Abutment Connection |
| 9mm | 25213 | | |
| 11mm | 25214 | | |
| 13mm | 25215 | | |
| 15mm | 25216 | | |
| 6mm | 25221 | 3.6 | |
| 8mm | 25222 | | |
| 9mm | 25223 | | |
| 11mm | 25224 | | |
| 13mm | 25225 | | |
| 15mm | 25226 | | |
| 17mm | 25227 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K120414) | 4.2 | 6mm | 25231 | 4.2 | |
| 8mm | 25232 | | |
| 9mm | 25233 | | |
| 11mm | 25234 | | |
| 13mm | 25235 | | |
| 15mm | 25236 | | |
| 17mm | 25237 | | |
| 6mm | 25241 | 4.8 | |
| 8mm | 25242 | | |
| 9mm | 25243 | | |
| 11mm | 25244 | | |
| 13mm | 25245 | | |
| 15mm | 25246 | | |
| 17mm | 25247 | | |
| 6mm | 25251 | 5.4 | |
| 8mm | 25252 | | |
| 9mm | 25253 | | |
| 11mm | 25254 | | |
| 13mm | 25255 | | |
| 15mm | 25256 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K041368) | 3.6 | 8 | FX3608SWC | 3.6 | |
| 10 | FX3610SWC | | |
| 12 | FX3612SWC | | |
| 14 | FX3614SWC | | |
| 8 | FX4008SWC | 4.0 | Internal Hex |
| 10 | FX4010SWC | | |
| 12 | FX4012SWC | | |
| 14 | FX4014SWC | | |
| 8 | FX4508SWC | 4.5 | |
| 10 | FX4510SWC | | |
| 12 | FX4512SWC | | |
| 14 | FX4514SWC | | |
| 8 | FX5008SWC | 5.0 | |
| 10 | FX5010SWC | | |
| 12 | FX5012SWC | | |
| 14 | FX5014SWC | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K192221) | 3.2 | 8 | 823208 | 3.0 | |
| 10 | 823210 | | |
| 11.5 | 823211 | | |
| 13 | 823213 | | |
| 16 | 823216 | | |
| 8 | FANIHX3508 | 3.1 | |
| 10 | FANIHX3510 | | |
| 11.5 | FANIHX3511 | | |
| 13 | FANIHX3513 | | |
| 15 | FANIHX3515 | | |
| 18 | FANIHX3518 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K140091) | 4.0 | 8 | FANIHX4008 | | |
| 10 | FANIHX4010 | | |
| 11.5 | FANIHX4011 | | |
| 13 | FANIHX4013 | | |
| 15 | FANIHX4015 | | |
| 18 | FANIHX4018 | | |
| 7 | FANIHX4508 | | |
| 8 | FANIHX4508 | | |
| 10 | FANIHX4510 | | |
| 11.5 | FANIHX4511 | | |
| 13 | FANIHX4513 | | |
| 15 | FANIHX4515 | | |
| 18 | FANIHX4518 | | |
| 7 | FANIHX5007 | 3.0 | Grand Morse connection |
| 8 | FANIHX5008 | | |
| 10 | FANIHX5010 | | |
| 11.5 | FANIHX5011 | | |
| 13 | FANIHX5013 | | |
| 15 | FANIHX5015 | | |
| 18 | FANIHX5018 | | |
| 7 | FANIHX5507 | | |
| 8 | FANIHX5508 | | |
| 10 | FANIHX5510 | | |
| 11.5 | FANIHX5511 | | |
| 13 | FANIHX5513 | | |
| 15 | FANIHX5515 | | |
| 18 | FANIHX5518 | | |
| 8 | 109.943 | | |
| 10 | 109.944 | | |
| 11.5 | 109.945 | | |
| 13 | 109.946 | | |
| 16 | 109.947 | | |
| 18 | 109.988 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K163194,
rel="noopener noreferrer" class="text-primary hover:underline break-words">K180536) | 3.75 | 8 | 109.976 | | |
| 10 | 109.977 | | |
| 11.5 | 109.978 | | |
| 13 | 109.979 | | |
| 16 | 109.980 | | |
| 18 | 109.981 | | |
| 8 | 109.982 | | |
| 10 | 109.983 | | |
| 11.5 | 109.984 | | |
| 13 | 109.985 | | |
| 16 | 109.986 | | |
| 18 | 109.987 | | |
| 8 | 109.948 | | |
| 10 | 109.949 | | |
| 11.5 | 109.950 | | |
| 13 | 109.951 | | |
| 16 | 109.952 | | |
| 18 | 109.989 | | |
| 8 | 109.953 | | |
| 10 | 109.954 | | |
| 11.5 | 109.955 | | |
| 13 | 109.956 | | |
| 16 | 109.957 | | |
| 18 | 109.990 | | |
| 8 | 109.1009 | | |
| 10 | 109.1010 | | |
| 11.5 | 109.1011 | | |
| 13 | 109.1012 | | |
| | | | |
| 10 | 36769 | 3.0 | |
| 11.5 | 36770 | | |
| 13 | 36771 | | |
| 15 | 36772 | | |
| 10 | 34125 | 3.5
|
| 11.5 | 34126 | | |
| 13 | 34127 | | |
| 15 | 34128 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K102436,
rel="noopener noreferrer" class="text-primary hover:underline break-words">K071370,
rel="noopener noreferrer" class="text-primary hover:underline break-words">K133731) | 4.3 | 10 | 34131 | 3.9
|
| 11.5 | 34132 | | |
| 13 | 34133 | | |
| 15 | 34134 | | |
| 10 | 34137 | 3.9
|
| 11.5 | 34138 | | |
| 13 | 34139 | | |
| 15 | 34140 | | |
| 10 | 37808 | 5.1
|
| 11.5 | 37809 | | |
| 13 | 37810 | | |
| 15 | 37811 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K121995) | 3.5 (3.75) | 8.5mm | TS3M3508S | 2.1
|
| 10mm | TS3M3510S | | |
| 11.5mm | TS3M3511S | | |
| 13mm | TS3M3015S | | |
| 4.0 (4.2) | 7mm | TS3S4007S | 2.5
|
| 8.5mm | TS3S4008S | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K173961,
rel="noopener noreferrer" class="text-primary hover:underline break-words">K181703,
rel="noopener noreferrer" class="text-primary hover:underline break-words">K191256) | 4.5 (4.6) | 10mm | TS3S4010S | | |
| 11.5mm | TS3S4011S | | |
| 13mm | TS3S4013S | | |
| 7mm | TS3S4507S | | |
| 8.5mm | TS3S4508S | | |
| 10mm | TS3S4510S | | |
| 11.5mm | TS3S4511S | | |
| 13mm | TS3S4513S | | Image: Internal Hex |
| 5.0 (5.1) | 7 mm | TS3S5007S | | |
| 8.5 mm | TS3S5008S | | |
| 10 mm | TS3S5010S | | |
| 11.5 mm | TS3S5011S | | |
| 13 mm | TS3S5013S | | |
| 8 | 061.3308 | Regular Base
|
| 061.3310 | | | |
| 061.3312 | | | |
| 061.3314 | | | |
| 061.3316 | | | |
| 061.3318 | | | |
| 061.4306 | | | |
| 061.4308 | | | |
| 061.4310 | | | |
| 061.4312 | | | |
| 061.4314 | | | |
| 061.4316 | | | |
| 061.4318 | | | |
| 061.5306 | | | |
| 061.5308 | | | |
| 061.5310 | | | |
| 061.5312 | | | |
| 061.5314 | | | |
| 061.5316 | | | |
| 061.5318 | | | |
| 061.6306 | | | |
| 061.6308 | | | |
| 061.6310 | | | |
| 061.6312 | | | |
| 061.6314 | | | |
| 16 | 061.6316 | Wide Base
|
| 18 | 061.6318 | | |
| 6 | 061.7306 | | |
| 8 | 061.7308 | | |
| 10 | 061.7310 | | |
| 12 | 061.7312 | | |
| 14 | 061.7314 | | |
| 16 | 061.7316 | | |
| 18 | 061.7318 | | |
| 6 | 061.8306 | | |
| 8 | 061.8308 | | |
| 10 | 061.8310 | | |
| 12 | 061.8312 | | |
| 6 | 061.9306 | | |
| 8 | 061.9308 | | |
| 10 | 061.9310 | | |
| 12 | 061.9312 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K162890) | 2.9 | 10 | 021.0010 | Small
|
| 12 | 021.0112 | | |
| 14 | 021.0114 | | |
| 8 | 021.3508 | Narrow
|
| 10 | 021.3510 | | |
| 12 | 021.3512 | | |
| 14 | 021.3514 | | |
| 16 | 021.3516 | | |
| 18 | 021.3518 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K140878) | 4.1 | 8 | 021.5508 | Regular
|
| 10 | 021.5510 | | |
| 12 | 021.5512 | | |
| 14 | 021.5514 | | |
| 16 | 021.5516 | | |
| 18 | 021.5518 | | |
| 8 | 021.7508 | | |
| 10 | 021.7510 | | |
| 12 | 021.7512 | | |
| 14 | 021.7514 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K142082) | | 16 | 021.7516 | | |
| 18 | 021.7518 | | |
| 8mm | CM318 | | |
| 10mm | CM3110 | | |
| 11.5mm | CM3111 | 2.9 | |
| 13mm | CM3113 | | |
| 16mm | CM3116 | | |
rel="noopener noreferrer" class="text-primary hover:underline break-words">K013227) | 3.7 | 8mm | TSVTB8 | 3.5 | Image: Internal Hex |
| 10mm | TSVTB10 | | |
| 11.5mm | TSVTB11 | | |
| 13mm | TSVTB13 | | |
| 16mm | TSVTB16 | 3.5 | |
| 8mm | TSVT4B8 | | |
| 10mm | TSVT4B10 | | |
| 11.5mm | TSVT4B11 | | |
| 13mm | TSVT4B13 | | |
| 16mm | TSVT4B16 | | |
| 8mm | TSVTWB8 | 4.5 | |
| 10mm | TSVTWB10 | | |
| 11.5mm | TSVTWB11 | | |
| 13mm | TSVTWB13 | | |
| 16mm | TSVTWB16 | | |
| 8mm | TSVT6B8 | 5.7 | |
| 10mm | TSVT6B10 | | |
| 11.5mm | TSVT6B11 | | |
| 13mm | TSVT6B13 | | |
| 16mm | TSVT6B16 | | |

8

Image /page/8/Picture/0 description: The image contains the word "ABUTMENT" in a stylized font. The "A" in "ABUTMENT" is larger than the other letters. The image also contains a graphic of a screw.

9

Image /page/9/Picture/0 description: The image contains the word "ABUTMENT" in a stylized font. The letters are in a sans-serif typeface and appear to be a light blue color. The bottom of the word is stylized to look like a screw.

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

10

Image /page/10/Picture/0 description: The image contains the word "ABUTMENT" in a stylized font. The letters are in a sans-serif typeface and appear to be a light blue color. The bottom of the word is stylized to look like a screw.

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

11

Image /page/11/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 word "ABUTMENT" is written in all caps, with the "A" slightly larger than the other letters.

12

Image /page/12/Picture/0 description: The image features a logo with the word "ABUTMENT" in bold, white letters at the top. Below the word, there is a stylized, blue graphic that resembles a screw or bolt. The graphic also incorporates the letters "ru" in a large, flowing font. The overall design is simple and modern, with a focus on the company name and a visual representation of its products or services.

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

13

Image /page/13/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 positioned above the rest of the word. The letters are in a blue color. The bottom of the image has a jagged edge, resembling the threads of a screw.

TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

14

Image /page/14/Picture/0 description: The image contains 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 in blue. To the left of the letters ".ru" is a graphic of a screw.

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.

AOT & T-L Abutment

1) AOT Abutment

	Subject Device	Predicate Devices
Part Name	AOT Abutment	Multi-unit Straight Abutment
Design	Image: AOT Abutment	Image: Multi-unit Straight Abutment
Applicant	TruAbutment Inc.	TruAbutment Korea Co., Ltd.
Trade Name	AOT & T-L Abutment	URIS OMNI Narrow System &
Prosthetic
510(K) No.	-	K200817
Classification
Name	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Indication
For Use/
Intended Use	AOT & T-L Abutment is intended for
use in conjunction with the fixture in
partially or fully edentulous mandibles
and maxillae, in support of multiple-unit
restorations.
It is compatible with the following
systems:
• Astra OsseoSpeed EV(K130999) 3.0
• Astra OsseoSpeed EV(K120414) 3.6,
4.2, 4.8, 5.4 mm
• Dentium Company Limited
Implantium (K041368): 3.6, 4.0, 4.5,
5.0 (Regular)
• Implant Direct Legacy2(K192221) 3.0
• Magagon AnuRidge Internal Implant	Multi-Unit Straight Abutment is
intended for use in conjunction with the
fixture in partially or fully edentulous
mandibles and maxillae, in support of
multiple-unit cement retained
restorations.
	System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4 (3.1)
	• Neodent Implant System - GM Helix (K163194, K180536) 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0 (3.0)
	• Nobel Active 3.0 (K102436) 3.0
	• Nobel Active Internal Connection Implant (K071370) NP RP 3.5, 4.3, 5.0
	• Nobelactive Wide Platform (Wp) (K133731) WP 5.0
	• TS Fixture System (K121995) 3.5 (3.75) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) mm (Mini, Regular)
	• Straumann BLX Implant (K173961, K181703, K191256) 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)
	• Straumann 02.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890) 2.9 (SC)
	• Straumann® Bone Level Tapered Implants (K140878) 3.3, 4.1, 4.8 (NC, RC)
	• Zimmer 3.1mmD Dental Implant System (K142082) 3.1 (2.9)
	• Screw Vent® and Tapered Screw Vent® (K013227) 3.7(3.5), 4.1(3.5), 4.7(4.5), 6.0(5.7)
Diameters	4.8mm	5.0mm
Lengths	G/H :1.0/2.0/3.0mm	G/H :1.0/2.0/3.0/4.0/5.0/6.0mm
Surface
Treatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device (AOT & T-L Abutment) is substantially equivalent to the predicate device (URIS OMNI Narrow System & Prosthetic, K200817). The subject device and the predicate device K182091 have internal connections, are made of Ti-6Al-4V ELI, and are conducted End User Steam Sterilization. The minor differences between the subject device and the primary predicate device are related to the compatible OEM implant lines and the implant platform diameter. The diameter of the primary predicate device is Ø5.0mm, while the subject device is Ø 4.8mm. The cuff height of the primary predicate device is 1.0mm~ 6.0mm, while the subject device can be designed from 1.0mm up to 3.0mm.
	Subject Device	Predicate Devices
Part Name	T-L Abutment	T LOC Straight Abutment
Design	Image: T-L Abutment	Image: T LOC Straight Abutment
Applicant	TruAbutment Inc.	TruAbutment Korea Co., Ltd.
Trade Name	AOT & T-L Abutment	URIS OMNI Narrow System &
Prosthetic
510(K) No.	-	K200817
Classification
Name	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Indication
For Use/
Intended Use	AOT & T-L Abutment is intended for
use in conjunction with the fixture in
partially or fully edentulous mandibles
and maxillae, in support of multiple-unit
restorations.
It is compatible with the following
systems:
• Astra OsseoSpeed EV(K130999) 3.0
• Astra OsseoSpeed EV(K120414) 3.6,
4.2, 4.8, 5.4 mm
• Dentium Company Limited
Implantium (K041368): 3.6, 4.0, 4.5,
5.0 (Regular)
• Implant Direct Legacy2(K192221) 3.0
• Megagen AnyRidge Internal Implant
System (K140091) 3.5, 4.0, 4.4, 4.9, 5.4
(3.1)
• Neodent Implant System - GM Helix
(K163194, K180536) 3.5, 3.75, 4.0, 4.3,
5.0 (3.0) 6.0 (3.0)
• Nobel Active 3.0 (K102436) 3.0	T LOC Straight Abutment is intended for
use in conjunction with the fixture in
partially or fully edentulous mandibles
and maxillae, in support of multiple-unit
cement retained restorations.
	Subject Device	Predicate Devices
Part Name	T-L Abutment	T LOC Straight Abutment
	Implant (K071370) NP RP 3.5, 4.3, 5.0
• Nobelactive Wide Platform (Wp)
(K133731) WP 5.0
• TS Fixture System (K121995) 3.5
(3.75) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1)
mm (Mini, Regular)
• Straumann BLX Implant (K173961,
K181703, K191256) 3.5, 3.75, 4.0, 4.5,
5.0, 5.5, 6.5 (RB, WB)
• Straumann 02.9 mm Bone Level
Tapered Implants, SC CARES
Abutments (K162890) 2.9 (SC)
• Straumann® Bone Level Tapered
Implants (K140878) 3.3, 4.1, 4.8 (NC,
RC)
• Zimmer 3.1mmD Dental Implant
System (K142082) 3.1 (2.9)
• Screw Vent® and Tapered Screw
Vent® (K013227) 3.7(3.5), 4.1(3.5),
4.7(4.5), 6.0(5.7)
Diameters	3.89mm	3.8mm
Lengths	G/H : 1.0/2.0/3.0/4.0/5.0/6.0 mm	G/H : 1.0/2.0/3.0/4.0/5.0/6.0 mm
Surface
Treatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device (AOT & T-L Abutment) is substantially equivalent to the
predicate device (URIS OMNI Narrow System & Prosthetic, K200817). The
subject device and the predicate device K200817 have internal connections, are
made of Ti-6Al-4V ELI, and are conducted End User Steam Sterilization. The
minor differences between the subject device and the primary predicate device
are related to the compatible OEM implant lines and the implant platform
diameter. The diameter of the primary predicate device is Ø3.8mm, while the
subject device is Ø 3.89mm.
	Subject Device	Predicate Devices
Part Name	AOT Temporary	Multi-unit Temporary Cylinder
Design	Image: AOT Temporary	Image: Multi-unit Temporary Cylinder
Applicant	TruAbutment Inc.	TruAbutment Korea Co., Ltd
Trade Name	AOT & T-L Abutment	URIS OMNI Narrow System &
Prosthetic
510(K) No.	-	K200817
Classification
Name	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)
Product
Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Indication
For Use/
Intended Use	AOT Temporary is intended to be
surgically placed in the maxillary or
mandibular molar areas for the purpose
providing prosthetic support for dental
restorations in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function.	Multi-unit Temporary Cylinder is
intended to be surgically placed in the
maxillary or mandibular molar areas
for the purpose providing prosthetic
support for dental restorations in
partially or fully edentulous
individuals. It is used to restore a
patient's chewing function.
Diameters	4.8mm	5.0mm
Lengths	12mm	12mm
Surface
Treatment	None	None
Maximum
Duration	Less than 6 months	Less than 6 months
Sterile	Non-sterile	Non-sterile
SE	The subject temporary abutment and Predicate devices are substantially
equivalent in intended use, material, surface treatment, design, dimension and
maximum duration of 6 months. K200817 is selected as a predicate device as it is
indicated for temporary restorations of crowns and bridges for up to six months.
The diameters of the subject device are slightly different from the predicate
devices. However, this dimensional difference doesn't affect substantial
equivalence.
	Subject Device	Predicate Devices
Part Name	AOT Base	Multi-unit Base
Design	Image: AOT Base design	Image: Multi-unit Base design
Applicant	TruAbutment Inc.	TruAbutment Korea Co., Ltd
Trade Name	AOT & T-L Abutment	URIS OMNI Narrow System & Prosthetic
510(K) No.	-	K200817
Classification
Name	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)
Product
Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Indication
For Use/
Intended Use	AOT Base is intended to be
surgically placed in the maxillary or
mandibular molar areas for the
purpose providing prosthetic
support for dental restorations in
partially or fully edentulous
individuals. It is used to restore a
patient's chewing function.	Multi-unit Base is intended to be
surgically placed in the maxillary or
mandibular molar areas for the purpose
providing prosthetic support for dental
restorations in partially or fully
edentulous individuals. It is used to
restore a patient's chewing function.
Diameters	5.3mm	5.0mm
Lengths	4.35/7.35mm	4.35/7.35mm
Surface
Treatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device and predicate devices (K200817) have the same intended use,
have similar technological characteristic, and are made of similar materials. The
subject device and predicate devices have similar physical dimensions, including
diameter. The diameters of the subject device are slightly different from the
predicate devices. However, this dimensional difference doesn't affect substantial
equivalence.
	Subject Device	Predicate Device
Part Name	AOT Base Screw/AOT Plus Screw
/Multi Unit Direct Screw	Multi-unit Cylinder Screw
Design	Image: AOT Base Screw/AOT Plus Screw/Multi Unit Direct Screw	Image: Multi-unit Cylinder Screw
Applicant	TruAbutment Inc.	TruAbutment Korea Co., Ltd
Trade Name	AOT & T-L Abutment	URIS OMNI Narrow System &
Prosthetic
510(K) No.	-	K200817
Classification
Name	Endosseous Dental Implant
Abutments(872.3630)	Endosseous Dental Implant
Abutments(872.3630)
Product Code	NHA	NHA
Material	Ti-6Al-4V ELI (ASTM F136)	Ti-6Al-4V ELI (ASTM F136)
Indication
For Use/
Intended Use	AOT Base Screw/AOT Plus
Screw/Multi Unit Direct Screw is a
pre-manufactured prosthetic
component directly connected to the
endosseous dental implant and is
intended for use as an aid in prosthetic
rehabilitation.	Multi-unit Cylinder Screw is a pre-
manufactured prosthetic component
directly connected to the endosseous
dental implant and is intended for use
as an aid in prosthetic rehabilitation.
Diameters	2.2mm / 2.25mm	1.6mm
Lengths	3.6mm / 4.4mm	3.3mm
Surface
Treatment	None	None
Sterile	Non-sterile	Non-sterile
SE	The subject device and reference devices (K200817) have the same intended use,
have similar technological characteristic, and are made of similar materials. The
subject device and predicate devices have similar physical dimensions, including
diameter and lengths. The diameters of the subject device are slightly different
from the predicate devices. However, this dimensional difference doesn't affect
substantial equivalence. The length of the primary predicate device is 3.3mm,
while the subject device is 3.6mm, 4.4mm.

15

Image /page/15/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is blue and features the word "Abutment" in a stylized font. The letters "ru" are larger than the rest of the word and are connected to a graphic of a screw.

16

Image /page/16/Picture/0 description: The image shows a logo for a company called "Abutment". The word "Abutment" is written in white letters with a blue background. Below the word "Abutment" are blue lines that resemble a screw. The letters "ru" are written in blue and are located to the right of the screw.

2) T-L Abutment

17

Image /page/17/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is primarily blue and white. The word "Abutment" is written in white, with the "A" being larger than the rest of the letters. Below the word "Abutment" is the letters "ru" in a larger, stylized font, also in blue. To the left of the letters "ru" is a graphic of a screw.

18

Image /page/18/Picture/0 description: The image shows a logo for a company called "Abutment". The word "Abutment" is written in white letters on a blue background. The first letter "A" is larger than the other letters. To the left of the word "Abutment" is a graphic of a screw.

3) AOT Component

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Image /page/19/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The "A" in "ABUTMENT" is larger than the other letters. Below the word "ABUTMENT" is a graphic that resembles a screw or bolt. The letters "ru" are written in a large, bold font that overlaps the screw graphic. The entire logo is in a light blue color.

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Image /page/20/Picture/0 description: The image features the word "ABUTMENT" in a stylized, sans-serif font. The letter "A" is larger than the rest of the word and is positioned slightly above the other letters. Below the word "ABUTMENT" is the letter "ru" in a similar font, with a design element resembling a screw thread to the left of the letters.

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Image /page/21/Picture/0 description: The image shows a logo for a company called "Abutment ru". The logo is primarily blue and features the word "ABUTMENT" in a stylized font, with the "A" being larger than the other letters. Below "ABUTMENT" is the text "ru" in a larger, more stylized font, with a design element resembling a screw or gear incorporated into the letter "r".

Substantial Equivalence Discussion

The subject device (AOT & T-L Abutment) 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 (AOT & T-L Abutment) is substantially equivalent in intended use to the primary predicate device (K200817). 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 (AOT & T-L Abutment) and primary predicate (K200817) 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 (AOT & T-L Abutment) and the primary predicate device (K200817) are related to the compatible OEM implant lines and the implant platform diameter.

The subject devices (AOT & T-L Abutment) are to be sterilized by the end-user, the same as primary predicate devices (K200817). Sterilization validation for the subject devices (AOT & T-L Abutment) was performed according to ISO 17665-1 and ISO 17665-2. This sterilization validation method is the same as the primary predicate devices (K200817).

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 be substantially equivalent to the predicate device..

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Image /page/22/Picture/0 description: The image shows a logo with the word "Abutment" in white, with the "A" slightly larger than the rest of the letters. Below the word "Abutment" is a stylized image of a tooth in blue. The tooth is angled slightly to the right, and the word "ru" is written in blue over the tooth.

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 (K152559, K200817) and leveraged for the subject device:
· End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-● 10:2010.

Non-clinical test data was used to evaluate the proposed device's substantial equivalence compared to the predicate device. The results of the above tests have met the criteria of the standard, and demonstrated the substantial equivalence with the predicate device.

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

Comparative fatigue testing of the subject and predicate devices was conducted in accordance with ISO 14801 and FDA Guidance "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments", and it consisted of testing finished assembled implant/abutment systems.

Conclusion

The AOT & T-L Abutment 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, AOT & T-L Abutment and its predicate are substantially equivalent.