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K Number
K231874
Device Name
AOT & T-L Abutment
Manufacturer
TruAbutment Inc.
Date Cleared
2023-10-30

(126 days)

Product Code
NHA
Regulation Number
872.3630
Type
Traditional
Panel
Dental
Reference & Predicate Devices
K120414,K130999,K041368,K192221,K140091,K163194,K102436,K071370,K133731,K121995,K173961,K181703,K191256,K162890,K140878,K142082,K013227,K200817
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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
  • · 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)
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.

AI/ML Overview

The provided document describes the TruAbutment Inc. AOT & T-L Abutment and its substantial equivalence to a predicate device. This document focuses on the non-clinical testing for dental implant abutments, primarily mechanical and sterilization performance, rather than clinical efficacy involving human readers or AI.

Therefore, many of the requested categories related to human-in-the-loop performance, statistical measures like effect size, and large-scale clinical study methodologies are not applicable to this 510(k) submission.

Here's a breakdown of the available information based on your request:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by compliance with specified ISO standards and FDA guidance documents. The reported device performance is that it met these criteria.

Acceptance Criteria (Standard / Guidance)Reported Device Performance
Fatigue Test: ISO 14801:2016Met the criteria of the standard.
End User Steam Sterilization: ISO 17665-1:2006, 17665-2:2009, ANSI/AAMI ST79:2010Met the criteria of the standard.
Biocompatibility: ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2010Met the criteria of the standard.
FDA Guidance: "Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments"Complied with the guidance for comparative fatigue testing.
Substantial Equivalence (Mechanical Strength): For all compatible OEM implant linesFatigue limit data demonstrated the construct strengths to be substantially equivalent to the predicate device.
Material: Ti-6Al-4V ELI (ASTM F136)Confirmed to be made of this material.
Sterile State: Non-sterile (end-user sterilization)Confirmed by sterilization validation.
Intended Use: Functionally equivalent to predicateVerified to be substantially equivalent in intended use.
Design/Dimensions: Similar to predicate (with minor differences considered acceptable)Dimensional analysis and reverse engineering indicated compatibility and substantial equivalence despite minor differences.

Study Details

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

    • Sample Size: Not explicitly stated for specific tests. For mechanical fatigue testing (ISO 14801), it mentions "worst-case constructs" were subjected to testing, implying a representative selection rather than a large clinical sample. Industry standards typically specify minimum sample sizes for such tests (e.g., 5-10 samples per test group for fatigue).
    • Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted third-party lab. It's a non-clinical, bench-top study.
    • Retrospective or Prospective: Non-clinical laboratory testing is neither retrospective nor prospective in the clinical sense. It's a controlled experimental study.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

    • Not applicable. This is a non-clinical, bench-top engineering and materials performance study, not a diagnostic or clinical efficacy study requiring expert human interpretation of data for ground truth. Compliance with engineering standards and material specifications forms the basis of "ground truth."

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

    • Not applicable. Adjudication methods are typically used in clinical trials or studies involving subjective human interpretation (e.g., image reading) to resolve discrepancies. This study involves objective measurements from laboratory tests.

  4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • Not applicable. This is a non-clinical technical performance study for dental implant abutments, not a study evaluating human reader performance or AI assistance.

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

    • Not applicable. This device is a physical dental abutment, not a software algorithm. The "standalone" performance here refers to the device's inherent mechanical properties and material characteristics as tested against engineering standards.

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

    • Ground Truth: Engineering standards (ISO 14801, ISO 17665, ISO 10993), material specifications (ASTM F136), and dimensional compatibility with OEM implant systems. Performance is measured objectively against these established criteria.

  7. The sample size for the training set:

    • Not applicable. There is no "training set" in the context of this non-clinical performance evaluation. This is not a machine learning or AI device.

  8. How the ground truth for the training set was established:

    • Not applicable for the same reason as above.

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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.

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

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

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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.

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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:

ImplantSystemImplantBodyDiameter(mm)ImplantLength (mm)Model No.ImplantPlatformDiameter(mm)Type of Implant-Abutment Connection
AstraOsseoSpeedEV(K130999)3.08mm252123.0Image: Implant Abutment Connection
9mm25213
11mm25214
13mm25215
15mm25216
3.66mm252213.6
8mm25222
9mm25223
11mm25224
13mm25225
15mm25226
17mm25227
AstraOsseoSpeedEV(K120414)4.26mm252314.2
8mm25232
9mm25233
11mm25234
13mm25235
15mm25236
17mm25237
4.86mm252414.8
8mm25242
9mm25243
11mm25244
13mm25245
15mm25246
17mm25247
5.46mm252515.4
8mm25252
9mm25253
11mm25254
13mm25255
15mm25256
DentiumSuperLine(K041368)3.68FX3608SWC3.6
10FX3610SWC
12FX3612SWC
14FX3614SWC
ImplantSystemImplantBodyDiameter(mm)ImplantLength (mm)Model No.ImplantPlatformDiameter(mm)Type of Implant-Abutment Connection
4.08FX4008SWC4.0Internal Hex
10FX4010SWC
12FX4012SWC
14FX4014SWC
4.58FX4508SWC4.5
10FX4510SWC
12FX4512SWC
14FX4514SWC
5.08FX5008SWC5.0
10FX5010SWC
12FX5012SWC
14FX5014SWC
ImplantDirectLegacy(K192221)3.288232083.0
10823210
11.5823211
13823213
16823216
3.58FANIHX35083.1
10FANIHX3510
11.5FANIHX3511
13FANIHX3513
15FANIHX3515
18FANIHX3518
MegagenAnyRidge(K140091)4.08FANIHX4008
10FANIHX4010
11.5FANIHX4011
13FANIHX4013
15FANIHX4015
18FANIHX4018
4.47FANIHX4508
8FANIHX4508
4.410FANIHX4510
11.5FANIHX4511
13FANIHX4513
15FANIHX4515
18FANIHX4518
ImplantSystemImplantBodyDiameter(mm)ImplantLength (mm)Model No.ImplantPlatformDiameter(mm)Type of Implant-Abutment Connection
4.97FANIHX50073.0Grand Morse connection
8FANIHX5008
10FANIHX5010
11.5FANIHX5011
13FANIHX5013
15FANIHX5015
18FANIHX5018
5.47FANIHX5507
8FANIHX5508
10FANIHX5510
11.5FANIHX5511
13FANIHX5513
15FANIHX5515
18FANIHX5518
3.58109.943
10109.944
11.5109.945
13109.946
16109.947
18109.988
Neodent GM(K163194,K180536)3.758109.976
10109.977
11.5109.978
13109.979
16109.980
18109.981
4.08109.982
10109.983
11.5109.984
13109.985
16109.986
18109.987
4.38109.948
10109.949
11.5109.950
13109.951
16109.952
ImplantSystemImplantBodyDiameter(mm)ImplantLength (mm)Model No.ImplantPlatformDiameter(mm)Type of Implant-Abutment Connection
5.018109.989
8109.953
10109.954
11.5109.955
13109.956
16109.957
18109.990
6.08109.1009
10109.1010
11.5109.1011
13109.1012
3.010367693.0
11.536770
1336771
1536772
3.510341253.5(NP)
11.534126
1334127
1534128
NobelActive(K102436,K071370,K133731)4.310341313.9(RP)Image: Internal Hex
11.534132
1334133
1534134
5.010341373.9(RP)
11.534138
1334139
1534140
5.510378085.1(WP)
11.537809
1337810
1537811
OSSTEM TS(K121995)3.5 (3.75)8.5mmTS3M3508S2.1(Mini)
10mmTS3M3510S
11.5mmTS3M3511S
13mmTS3M3015S
4.0 (4.2)7mmTS3S4007S2.5(Regular)
8.5mmTS3S4008S
ImplantSystemImplantBodyDiameter(mm)ImplantLength (mm)Model No.ImplantPlatformDiameter(mm)Type of Implant-Abutment Connection
Straumann BLX(K173961,K181703,K191256)4.5 (4.6)10mmTS3S4010S
11.5mmTS3S4011S
13mmTS3S4013S
7mmTS3S4507S
8.5mmTS3S4508S
10mmTS3S4510S
11.5mmTS3S4511S
13mmTS3S4513SImage: Internal Hex
5.0 (5.1)7 mmTS3S5007S
8.5 mmTS3S5008S
10 mmTS3S5010S
11.5 mmTS3S5011S
13 mmTS3S5013S
3.58061.3308Regular Base(RB)Image: TorcFit connection
10061.3310
12061.3312
14061.3314
16061.3316
18061.3318
3.756061.4306
8061.4308
10061.4310
12061.4312
14061.4314
16061.4316
18061.4318
4.06061.5306
8061.5308
10061.5310
12061.5312
14061.5314
16061.5316
18061.5318
4.56061.6306
8061.6308
10061.6310
12061.6312
14061.6314
ImplantSystemImplantBodyDiameter(mm)ImplantLength (mm)Model No.ImplantPlatformDiameter(mm)Type of Implant-Abutment Connection
5.016061.6316Wide Base(WB)
18061.6318
6061.7306
8061.7308
10061.7310
12061.7312
14061.7314
16061.7316
18061.7318
5.56061.8306
8061.8308
10061.8310
12061.8312
6.56061.9306
8061.9308
10061.9310
12061.9312
StraumannBone LevelImplantsSC(K162890)2.910021.0010SmallCrossfit(SC)
12021.0112
14021.0114
3.38021.3508NarrowCrossfit(NC)
10021.3510
12021.3512
14021.3514
16021.3516
18021.3518
StraumannBone LevelImplantsNC, RC(K140878)4.18021.5508RegularCrossfit(RC)
10021.5510
12021.5512
14021.5514
16021.5516
18021.5518
4.88021.7508
10021.7510
12021.7512
14021.7514
ImplantSystemImplantBodyDiameter(mm)ImplantLength (mm)Model No.ImplantPlatformDiameter(mm)Type of Implant-Abutment Connection
Zimmer3.1mmDDentalImplantSystem(K142082)16021.7516
18021.7518
8mmCM318
10mmCM3110
3.111.5mmCM31112.9
13mmCM3113
16mmCM3116
Screw Vent®and TaperedScrew Vent®(K013227)3.78mmTSVTB83.5Image: Internal Hex
10mmTSVTB10
11.5mmTSVTB11
13mmTSVTB13
4.116mmTSVTB163.5
8mmTSVT4B8
10mmTSVT4B10
11.5mmTSVT4B11
13mmTSVT4B13
16mmTSVT4B16
4.78mmTSVTWB84.5
10mmTSVTWB10
11.5mmTSVTWB11
13mmTSVTWB13
16mmTSVTWB16
6.08mmTSVT6B85.7
10mmTSVT6B10
11.5mmTSVT6B11
13mmTSVT6B13
16mmTSVT6B16

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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.

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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

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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

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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.

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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

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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

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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 DevicePredicate Devices
Part NameAOT AbutmentMulti-unit Straight Abutment
DesignImage: AOT AbutmentImage: Multi-unit Straight Abutment
ApplicantTruAbutment Inc.TruAbutment Korea Co., Ltd.
Trade NameAOT & T-L AbutmentURIS OMNI Narrow System &Prosthetic
510(K) No.-K200817
ClassificationNameEndosseous Dental ImplantAbutments(872.3630)Endosseous Dental ImplantAbutments(872.3630)
Product CodeNHANHA
MaterialTi-6Al-4V ELI (ASTM F136)Ti-6Al-4V ELI (ASTM F136)
IndicationFor Use/Intended UseAOT & T-L Abutment is intended foruse in conjunction with the fixture inpartially or fully edentulous mandiblesand maxillae, in support of multiple-unitrestorations.It is compatible with the followingsystems:• Astra OsseoSpeed EV(K130999) 3.0• Astra OsseoSpeed EV(K120414) 3.6,4.2, 4.8, 5.4 mm• Dentium Company LimitedImplantium (K041368): 3.6, 4.0, 4.5,5.0 (Regular)• Implant Direct Legacy2(K192221) 3.0• Magagon AnuRidge Internal ImplantMulti-Unit Straight Abutment isintended for use in conjunction with thefixture in partially or fully edentulousmandibles and maxillae, in support ofmultiple-unit cement retainedrestorations.
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)
Diameters4.8mm5.0mm
LengthsG/H :1.0/2.0/3.0mmG/H :1.0/2.0/3.0/4.0/5.0/6.0mm
SurfaceTreatmentNoneNone
SterileNon-sterileNon-sterile
SEThe 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 DevicePredicate Devices
Part NameT-L AbutmentT LOC Straight Abutment
DesignImage: T-L AbutmentImage: T LOC Straight Abutment
ApplicantTruAbutment Inc.TruAbutment Korea Co., Ltd.
Trade NameAOT & T-L AbutmentURIS OMNI Narrow System &Prosthetic
510(K) No.-K200817
ClassificationNameEndosseous Dental ImplantAbutments(872.3630)Endosseous Dental ImplantAbutments(872.3630)
Product CodeNHANHA
MaterialTi-6Al-4V ELI (ASTM F136)Ti-6Al-4V ELI (ASTM F136)
IndicationFor Use/Intended UseAOT & T-L Abutment is intended foruse in conjunction with the fixture inpartially or fully edentulous mandiblesand maxillae, in support of multiple-unitrestorations.It is compatible with the followingsystems:• Astra OsseoSpeed EV(K130999) 3.0• Astra OsseoSpeed EV(K120414) 3.6,4.2, 4.8, 5.4 mm• Dentium Company LimitedImplantium (K041368): 3.6, 4.0, 4.5,5.0 (Regular)• Implant Direct Legacy2(K192221) 3.0• Megagen AnyRidge Internal ImplantSystem (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) 3.0T LOC Straight Abutment is intended foruse in conjunction with the fixture inpartially or fully edentulous mandiblesand maxillae, in support of multiple-unitcement retained restorations.
Subject DevicePredicate Devices
Part NameT-L AbutmentT 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 LevelTapered Implants, SC CARESAbutments (K162890) 2.9 (SC)• Straumann® Bone Level TaperedImplants (K140878) 3.3, 4.1, 4.8 (NC,RC)• Zimmer 3.1mmD Dental ImplantSystem (K142082) 3.1 (2.9)• Screw Vent® and Tapered ScrewVent® (K013227) 3.7(3.5), 4.1(3.5),4.7(4.5), 6.0(5.7)
Diameters3.89mm3.8mm
LengthsG/H : 1.0/2.0/3.0/4.0/5.0/6.0 mmG/H : 1.0/2.0/3.0/4.0/5.0/6.0 mm
SurfaceTreatmentNoneNone
SterileNon-sterileNon-sterile
SEThe subject device (AOT & T-L Abutment) is substantially equivalent to thepredicate device (URIS OMNI Narrow System & Prosthetic, K200817). Thesubject device and the predicate device K200817 have internal connections, aremade of Ti-6Al-4V ELI, and are conducted End User Steam Sterilization. Theminor differences between the subject device and the primary predicate deviceare related to the compatible OEM implant lines and the implant platformdiameter. The diameter of the primary predicate device is Ø3.8mm, while thesubject device is Ø 3.89mm.
Subject DevicePredicate Devices
Part NameAOT TemporaryMulti-unit Temporary Cylinder
DesignImage: AOT TemporaryImage: Multi-unit Temporary Cylinder
ApplicantTruAbutment Inc.TruAbutment Korea Co., Ltd
Trade NameAOT & T-L AbutmentURIS OMNI Narrow System &Prosthetic
510(K) No.-K200817
ClassificationNameEndosseous Dental ImplantAbutments(872.3630)Endosseous Dental ImplantAbutments(872.3630)
ProductCodeNHANHA
MaterialTi-6Al-4V ELI (ASTM F136)Ti-6Al-4V ELI (ASTM F136)
IndicationFor Use/Intended UseAOT Temporary is intended to besurgically placed in the maxillary ormandibular molar areas for the purposeproviding prosthetic support for dentalrestorations in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.Multi-unit Temporary Cylinder isintended to be surgically placed in themaxillary or mandibular molar areasfor the purpose providing prostheticsupport for dental restorations inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function.
Diameters4.8mm5.0mm
Lengths12mm12mm
SurfaceTreatmentNoneNone
MaximumDurationLess than 6 monthsLess than 6 months
SterileNon-sterileNon-sterile
SEThe subject temporary abutment and Predicate devices are substantiallyequivalent in intended use, material, surface treatment, design, dimension andmaximum duration of 6 months. K200817 is selected as a predicate device as it isindicated for temporary restorations of crowns and bridges for up to six months.The diameters of the subject device are slightly different from the predicatedevices. However, this dimensional difference doesn't affect substantialequivalence.
Subject DevicePredicate Devices
Part NameAOT BaseMulti-unit Base
DesignImage: AOT Base designImage: Multi-unit Base design
ApplicantTruAbutment Inc.TruAbutment Korea Co., Ltd
Trade NameAOT & T-L AbutmentURIS OMNI Narrow System & Prosthetic
510(K) No.-K200817
ClassificationNameEndosseous Dental ImplantAbutments(872.3630)Endosseous Dental ImplantAbutments(872.3630)
ProductCodeNHANHA
MaterialTi-6Al-4V ELI (ASTM F136)Ti-6Al-4V ELI (ASTM F136)
IndicationFor Use/Intended UseAOT Base is intended to besurgically placed in the maxillary ormandibular molar areas for thepurpose providing prostheticsupport for dental restorations inpartially or fully edentulousindividuals. It is used to restore apatient's chewing function.Multi-unit Base is intended to besurgically placed in the maxillary ormandibular molar areas for the purposeproviding prosthetic support for dentalrestorations in partially or fullyedentulous individuals. It is used torestore a patient's chewing function.
Diameters5.3mm5.0mm
Lengths4.35/7.35mm4.35/7.35mm
SurfaceTreatmentNoneNone
SterileNon-sterileNon-sterile
SEThe subject device and predicate devices (K200817) have the same intended use,have similar technological characteristic, and are made of similar materials. Thesubject device and predicate devices have similar physical dimensions, includingdiameter. The diameters of the subject device are slightly different from thepredicate devices. However, this dimensional difference doesn't affect substantialequivalence.
Subject DevicePredicate Device
Part NameAOT Base Screw/AOT Plus Screw/Multi Unit Direct ScrewMulti-unit Cylinder Screw
DesignImage: AOT Base Screw/AOT Plus Screw/Multi Unit Direct ScrewImage: Multi-unit Cylinder Screw
ApplicantTruAbutment Inc.TruAbutment Korea Co., Ltd
Trade NameAOT & T-L AbutmentURIS OMNI Narrow System &Prosthetic
510(K) No.-K200817
ClassificationNameEndosseous Dental ImplantAbutments(872.3630)Endosseous Dental ImplantAbutments(872.3630)
Product CodeNHANHA
MaterialTi-6Al-4V ELI (ASTM F136)Ti-6Al-4V ELI (ASTM F136)
IndicationFor Use/Intended UseAOT Base Screw/AOT PlusScrew/Multi Unit Direct Screw is apre-manufactured prostheticcomponent directly connected to theendosseous dental implant and isintended for use as an aid in prostheticrehabilitation.Multi-unit Cylinder Screw is a pre-manufactured prosthetic componentdirectly connected to the endosseousdental implant and is intended for useas an aid in prosthetic rehabilitation.
Diameters2.2mm / 2.25mm1.6mm
Lengths3.6mm / 4.4mm3.3mm
SurfaceTreatmentNoneNone
SterileNon-sterileNon-sterile
SEThe subject device and reference devices (K200817) have the same intended use,have similar technological characteristic, and are made of similar materials. Thesubject device and predicate devices have similar physical dimensions, includingdiameter and lengths. The diameters of the subject device are slightly differentfrom the predicate devices. However, this dimensional difference doesn't affectsubstantial equivalence. The length of the primary predicate device is 3.3mm,while the subject device is 3.6mm, 4.4mm.

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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.

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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

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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.

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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.

§ 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.)