AOT & T-L Abutment

K231874 · Truabutment, Inc. · NHA · Oct 30, 2023 · Dental

Device Facts

• Record ID: K231874
• Device Name: AOT & T-L Abutment
• Applicant: Truabutment, Inc.
• Product Code: NHA · Dental
• Decision Date: Oct 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

AOT & T-L Abutment system consists of titanium (Ti-6Al-4V ELI) abutments and components (base, temporary, screws) designed to connect endosseous dental implants to prosthetic restorations (bridges/dentures). Used in dental clinics by authorized healthcare providers; the device is provided non-sterile and requires end-user steam sterilization. The abutments interface with various OEM implant systems via specific internal connections. By providing a stable mechanical connection between the implant fixture and the prosthetic, the device restores chewing function and supports esthetic rehabilitation for edentulous patients.

Clinical Evidence

Bench testing only. Evidence includes fatigue testing per ISO 14801:2016, dimensional analysis, and reverse engineering of implant-to-abutment connections. Sterilization validation performed per ISO 17665-1/2 and ANSI/AAMI ST79. Biocompatibility leveraged from predicate devices per ISO 10993 standards.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136). Design: Straight multi-unit abutments and components. Connection: Internal implant-abutment connections. Sterilization: Non-sterile, requires end-user steam sterilization. Mechanical testing: ISO 14801 fatigue testing.

Indications for Use

Indicated for partially or fully edentulous patients (maxilla/mandible) requiring multiple-unit dental restorations supported by endosseous dental implants.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• URIS OMNI Narrow Implant System (K200817)

Reference Devices

• 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)

Submission Summary (Full Text)

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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.

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

| <span style="text-decoration: underline;"></span> | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------------------------------------------|----------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"></span> | <input type="checkbox"/> 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: [e-mail] Phone: [phone]

Official Correspondent

TruAbutment Inc. Chris Kim 17666 Fitch, Irvine, CA 92614 USA Email: [e-mail] Phone: [phone]

### 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:

| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length (mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
|--------------------------------------------------------------|-------------------------------------|------------------------|------------|-----------------------------------------|-----------------------------------------|
| Astra<br>OsseoSpeed<br>EV<br>(K130999) | 3.0 | 8mm | 25212 | 3.0 | Image: Implant Abutment Connection |
| | | 9mm | 25213 | | |
| | | 11mm | 25214 | | |
| | | 13mm | 25215 | | |
| | | 15mm | 25216 | | |
| | 3.6 | 6mm | 25221 | 3.6 | |
| | | 8mm | 25222 | | |
| | | 9mm | 25223 | | |
| | | 11mm | 25224 | | |
| | | 13mm | 25225 | | |
| | | 15mm | 25226 | | |
| | | 17mm | 25227 | | |
| Astra<br>OsseoSpeed<br>EV<br>(K120414) | 4.2 | 6mm | 25231 | 4.2 | |
| | | 8mm | 25232 | | |
| | | 9mm | 25233 | | |
| | | 11mm | 25234 | | |
| | | 13mm | 25235 | | |
| | | 15mm | 25236 | | |
| | | 17mm | 25237 | | |
| | 4.8 | 6mm | 25241 | 4.8 | |
| | | 8mm | 25242 | | |
| | | 9mm | 25243 | | |
| | | 11mm | 25244 | | |
| | | 13mm | 25245 | | |
| | | 15mm | 25246 | | |
| | | 17mm | 25247 | | |
| | 5.4 | 6mm | 25251 | 5.4 | |
| | | 8mm | 25252 | | |
| | | 9mm | 25253 | | |
| | | 11mm | 25254 | | |
| | | 13mm | 25255 | | |
| | | 15mm | 25256 | | |
| Dentium<br>SuperLine<br>(K041368) | 3.6 | 8 | FX3608SWC | 3.6 | |
| | | 10 | FX3610SWC | | |
| | | 12 | FX3612SWC | | |
| | | 14 | FX3614SWC | | |
| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length (mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
| | 4.0 | 8 | FX4008SWC | 4.0 | Internal Hex |
| | | 10 | FX4010SWC | | |
| | | 12 | FX4012SWC | | |
| | | 14 | FX4014SWC | | |
| | 4.5 | 8 | FX4508SWC | 4.5 | |
| | | 10 | FX4510SWC | | |
| | | 12 | FX4512SWC | | |
| | | 14 | FX4514SWC | | |
| | 5.0 | 8 | FX5008SWC | 5.0 | |
| | | 10 | FX5010SWC | | |
| | | 12 | FX5012SWC | | |
| | | 14 | FX5014SWC | | |
| Implant<br>Direct<br>Legacy<br>(K192221) | 3.2 | 8 | 823208 | 3.0 | |
| | | 10 | 823210 | | |
| | | 11.5 | 823211 | | |
| | | 13 | 823213 | | |
| | | 16 | 823216 | | |
| | 3.5 | 8 | FANIHX3508 | 3.1 | |
| | | 10 | FANIHX3510 | | |
| | | 11.5 | FANIHX3511 | | |
| | | 13 | FANIHX3513 | | |
| | | 15 | FANIHX3515 | | |
| | | 18 | FANIHX3518 | | |
| Megagen<br>AnyRidge<br>(K140091) | 4.0 | 8 | FANIHX4008 | | |
| | | 10 | FANIHX4010 | | |
| | | 11.5 | FANIHX4011 | | |
| | | 13 | FANIHX4013 | | |
| | | 15 | FANIHX4015 | | |
| | | 18 | FANIHX4018 | | |
| | 4.4 | 7 | FANIHX4508 | | |
| | | 8 | FANIHX4508 | | |
| | 4.4 | 10 | FANIHX4510 | | |
| | | 11.5 | FANIHX4511 | | |
| | | 13 | FANIHX4513 | | |
| | | 15 | FANIHX4515 | | |
| | | 18 | FANIHX4518 | | |
| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length (mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
| | 4.9 | 7 | FANIHX5007 | 3.0 | Grand Morse connection |
| | | 8 | FANIHX5008 | | |
| | | 10 | FANIHX5010 | | |
| | | 11.5 | FANIHX5011 | | |
| | | 13 | FANIHX5013 | | |
| | | 15 | FANIHX5015 | | |
| | | 18 | FANIHX5018 | | |
| | 5.4 | 7 | FANIHX5507 | | |
| | | 8 | FANIHX5508 | | |
| | | 10 | FANIHX5510 | | |
| | | 11.5 | FANIHX5511 | | |
| | | 13 | FANIHX5513 | | |
| | | 15 | FANIHX5515 | | |
| | | 18 | FANIHX5518 | | |
| | 3.5 | 8 | 109.943 | | |
| | | 10 | 109.944 | | |
| | | 11.5 | 109.945 | | |
| | | 13 | 109.946 | | |
| | | 16 | 109.947 | | |
| | | 18 | 109.988 | | |
| Neodent GM<br>(K163194,<br>K180536) | 3.75 | 8 | 109.976 | | |
| | | 10 | 109.977 | | |
| | | 11.5 | 109.978 | | |
| | | 13 | 109.979 | | |
| | | 16 | 109.980 | | |
| | | 18 | 109.981 | | |
| | 4.0 | 8 | 109.982 | | |
| | | 10 | 109.983 | | |
| | | 11.5 | 109.984 | | |
| | | 13 | 109.985 | | |
| | | 16 | 109.986 | | |
| | | 18 | 109.987 | | |
| | 4.3 | 8 | 109.948 | | |
| | | 10 | 109.949 | | |
| | | 11.5 | 109.950 | | |
| | | 13 | 109.951 | | |
| | | 16 | 109.952 | | |
| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length (mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
| | 5.0 | 18 | 109.989 | | |
| | | 8 | 109.953 | | |
| | | 10 | 109.954 | | |
| | | 11.5 | 109.955 | | |
| | | 13 | 109.956 | | |
| | | 16 | 109.957 | | |
| | | 18 | 109.990 | | |
| | 6.0 | 8 | 109.1009 | | |
| | | 10 | 109.1010 | | |
| | | 11.5 | 109.1011 | | |
| | | 13 | 109.1012 | | |
| | | | | | |
| | 3.0 | 10 | 36769 | 3.0 | |
| | | 11.5 | 36770 | | |
| | | 13 | 36771 | | |
| | | 15 | 36772 | | |
| | 3.5 | 10 | 34125 | 3.5<br>(NP) | |
| | | 11.5 | 34126 | | |
| | | 13 | 34127 | | |
| | | 15 | 34128 | | |
| NobelActive<br>(K102436,<br>K071370,<br>K133731) | 4.3 | 10 | 34131 | 3.9<br>(RP) | Image: Internal Hex |
| | | 11.5 | 34132 | | |
| | | 13 | 34133 | | |
| | | 15 | 34134 | | |
| | 5.0 | 10 | 34137 | 3.9<br>(RP) | |
| | | 11.5 | 34138 | | |
| | | 13 | 34139 | | |
| | | 15 | 34140 | | |
| | 5.5 | 10 | 37808 | 5.1<br>(WP) | |
| | | 11.5 | 37809 | | |
| | | 13 | 37810 | | |
| | | 15 | 37811 | | |
| OSSTEM TS<br>(K121995) | 3.5 (3.75) | 8.5mm | TS3M3508S | 2.1<br>(Mini) | |
| | | 10mm | TS3M3510S | | |
| | | 11.5mm | TS3M3511S | | |
| | | 13mm | TS3M3015S | | |
| | 4.0 (4.2) | 7mm | TS3S4007S | 2.5<br>(Regular) | |
| | | 8.5mm | TS3S4008S | | |
| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length (mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
| Straumann BLX<br>(K173961,<br>K181703,<br>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 | | |
| 3.5 | | 8 | 061.3308 | Regular Base<br>(RB) | Image: TorcFit connection |
| | 10 | 061.3310 | | | |
| | 12 | 061.3312 | | | |
| | 14 | 061.3314 | | | |
| | 16 | 061.3316 | | | |
| | 18 | 061.3318 | | | |
| 3.75 | 6 | 061.4306 | | | |
| | 8 | 061.4308 | | | |
| | 10 | 061.4310 | | | |
| | 12 | 061.4312 | | | |
| | 14 | 061.4314 | | | |
| | 16 | 061.4316 | | | |
| | 18 | 061.4318 | | | |
| 4.0 | 6 | 061.5306 | | | |
| | 8 | 061.5308 | | | |
| | 10 | 061.5310 | | | |
| | 12 | 061.5312 | | | |
| | 14 | 061.5314 | | | |
| | 16 | 061.5316 | | | |
| | 18 | 061.5318 | | | |
| 4.5 | 6 | 061.6306 | | | |
| | 8 | 061.6308 | | | |
| | 10 | 061.6310 | | | |
| | 12 | 061.6312 | | | |
| | 14 | 061.6314 | | | |
| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length (mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
| | 5.0 | 16 | 061.6316 | Wide Base<br>(WB) | |
| | | 18 | 061.6318 | | |
| | | 6 | 061.7306 | | |
| | | 8 | 061.7308 | | |
| | | 10 | 061.7310 | | |
| | | 12 | 061.7312 | | |
| | | 14 | 061.7314 | | |
| | | 16 | 061.7316 | | |
| | | 18 | 061.7318 | | |
| | 5.5 | 6 | 061.8306 | | |
| | | 8 | 061.8308 | | |
| | | 10 | 061.8310 | | |
| | | 12 | 061.8312 | | |
| | 6.5 | 6 | 061.9306 | | |
| | | 8 | 061.9308 | | |
| | | 10 | 061.9310 | | |
| | | 12 | 061.9312 | | |
| Straumann<br>Bone Level<br>Implants<br>SC<br>(K162890) | 2.9 | 10 | 021.0010 | Small<br>Crossfit<br>(SC) | |
| | | 12 | 021.0112 | | |
| | | 14 | 021.0114 | | |
| | 3.3 | 8 | 021.3508 | Narrow<br>Crossfit<br>(NC) | |
| | | 10 | 021.3510 | | |
| | | 12 | 021.3512 | | |
| | | 14 | 021.3514 | | |
| | | 16 | 021.3516 | | |
| | | 18 | 021.3518 | | |
| Straumann<br>Bone Level<br>Implants<br>NC, RC<br>(K140878) | 4.1 | 8 | 021.5508 | Regular<br>Crossfit<br>(RC) | |
| | | 10 | 021.5510 | | |
| | | 12 | 021.5512 | | |
| | | 14 | 021.5514 | | |
| | | 16 | 021.5516 | | |
| | | 18 | 021.5518 | | |
| | 4.8 | 8 | 021.7508 | | |
| | | 10 | 021.7510 | | |
| | | 12 | 021.7512 | | |
| | | 14 | 021.7514 | | |
| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length (mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
| Zimmer<br>3.1mmD<br>Dental<br>Implant<br>System<br>(K142082) | | 16 | 021.7516 | | |
| | | 18 | 021.7518 | | |
| | | 8mm | CM318 | | |
| | | 10mm | CM3110 | | |
| | 3.1 | 11.5mm | CM3111 | 2.9 | |
| | | 13mm | CM3113 | | |
| | | 16mm | CM3116 | | |
| Screw Vent®<br>and Tapered<br>Screw Vent®<br>(K013227) | 3.7 | 8mm | TSVTB8 | 3.5 | Image: Internal Hex |
| | | 10mm | TSVTB10 | | |
| | | 11.5mm | TSVTB11 | | |
| | | 13mm | TSVTB13 | | |
| | 4.1 | 16mm | TSVTB16 | 3.5 | |
| | | 8mm | TSVT4B8 | | |
| | | 10mm | TSVT4B10 | | |
| | | 11.5mm | TSVT4B11 | | |
| | | 13mm | TSVT4B13 | | |
| | | 16mm | TSVT4B16 | | |
| | 4.7 | 8mm | TSVTWB8 | 4.5 | |
| | | 10mm | TSVTWB10 | | |
| | | 11.5mm | TSVTWB11 | | |
| | | 13mm | TSVTWB13 | | |
| | | 16mm | TSVTWB16 | | |
| | 6.0 | 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.…