TruAbutment DS, TruBase

K202579 · Truabutment, Inc. · NHA · Jul 8, 2021 · Dental

Device Facts

• Record ID: K202579
• Device Name: TruAbutment DS, TruBase
• Applicant: Truabutment, Inc.
• Product Code: NHA · Dental
• Decision Date: Jul 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

TruAbutment DS is a patient-specific CAD/CAM abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. TruBase is a titanium component that is directly connected to endosseous dental implants to provide support for patient-specific prosthetic restorations, such as copings or crowns. It is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

Device Story

TruAbutment DS and TruBase are patient-specific dental abutments used for prosthetic rehabilitation. TruAbutment DS is a CAD/CAM abutment; TruBase is a two-piece system consisting of a titanium base supporting a CAD/CAM zirconia superstructure. Inputs include patient intra-oral data processed via CAD/CAM systems to design custom abutments. Devices are manufactured at a validated milling center. The abutments are connected to endosseous dental implants using titanium screws (Ti-6Al-4V ELI). Used in dental clinics by authorized healthcare providers. The output is a custom abutment/superstructure that supports crowns or bridges, restoring chewing function and aesthetics. Benefits include patient-specific fit and functional restoration. Devices are provided non-sterile and require end-user sterilization.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including static compression and compression fatigue testing per ISO 14801:2016, dimensional analysis, and reverse engineering of implant-to-abutment connections. Biocompatibility and sterilization validation (ISO 17665-1/2, ISO 10993) were leveraged from previous predicate submissions (K152559, K170259).

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136) for abutments/screws; Zirconia (InCoris Zi) for superstructures. Design: Patient-specific CAD/CAM machined. Connection: Internal implant-abutment interface. Sterilization: Moist steam (end-user). Connectivity: Compatible with various OEM implant platforms. Software: 3Shape Abutment Designer (K151455).

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants. Compatible with specific Astra Tech, Dentium, PrimaConnex, Straumann, and Xpeed AnyRidge implant systems for single tooth or bridge restorations.

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

• TruAbutment DS, TruBase S (K201197)

Reference Devices

• Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (K024111)
• Astra Tech Implant System (K101732)
• Dentium Company Limited Implantium (K041368)
• Lifecore PrimaConnex Internal Connection Implant System (K051614)
• Xpeed AnyRidge Internal Implant System (K140091)
• Straumann Ø2.9 mm Bone Level Tapered Implants, SC CARES Abutments (K162890)
• Straumann Bone Level Tapered Implants (K140878)

Submission Summary (Full Text)

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

July 08, 2021

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

Re: K202579

Trade/Device Name: TruAbutment DS, TruBase Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: April 26, 2021 Received: June 7, 2021

Dear Chris Choi:

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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

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

Sincerely.

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

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# Indications for Use

Device Name TruAbutment DS, TruBase

Indications for Use (Describe)

TruAbutment DS

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

· Astra Tech Implant System (K101732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)

· Dentium Company Limited Implantium (K041368): 3.4. 3.8. 4.3. 4.8 (Regular)

· PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)

· Straumann Ø2.9 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)

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <table style="border:none"><tr><td><div style="display:inline-block; margin-right: 10px;"> <span style="font-size: 1.2em;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> <div style="display:inline-block;"> <span style="font-size: 1.2em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div style="display:inline-block; margin-right: 10px;"> <span style="font-size: 1.2em;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> <div style="display:inline-block;"> <span style="font-size: 1.2em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
| <div style="display:inline-block; margin-right: 10px;"> <span style="font-size: 1.2em;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> <div style="display:inline-block;"> <span style="font-size: 1.2em;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | |

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## Indications for Use

510(k) Number (if known) K202579

Device Name TruAbutment DS, TruBase

Indications for Use (Describe) TruBase

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

• Astra Tech Implant System (K101732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)

- · Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular)
- · PrimaConnexTM Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)

· Straumann Ø2.9 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)

• Xpeed AnyRidge Internal Implant System (K140091): 4.0, 4.4, 4.9, 5.4, 5.9 (3.5)

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

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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

of this information collection, including suggestions for reducing this burden, to:

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Image /page/4/Picture/0 description: The image is a logo for Abutment. The logo is blue and features the word "Abutment" in a stylized font. The "A" is larger than the other letters and is placed above the rest of the word. Below the word "Abutment" is a graphic that resembles a screw or bolt. The logo is simple and eye-catching, and it effectively communicates the company's name and brand.

# 510(k) Summary K202579

#### Submitter

TruAbutment Inc. Eunjin Jang 17742 Cowan, Irvine, CA 92614 USA Email: [e-mail] Phone: [phone]

#### Official Correspondent

TruAbutment Inc. Chris Choi 17742 Cowan, Irvine, CA 92614 USA Email: [e-mail] Phone: [phone]

## Device Information

- . Trade Name: TruAbutment DS, TruBase
- Common Name: Endosseous dental implant abutment ●
- Classification Name: Abutment, Implant, Dental, Endosseous ●
- Product Code: NHA ●
- . Panel: Dental
- Regulation Number: 21 CFR 872.3630 .
- Device Class: Class II ●
- Date prepared: 07/07/2021 ●

#### Primary Predicate:

- TruAbutment DS, TruBase S (K201197) by TruAbutment Inc.
#### Reference Devices:

- Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111) by Astra Tech, Inc.
- Astra Tech Implant System (K101732) by Astra Tech AB.
- Dentium Company Limited Implantium (K041368) by Dentium Co., Ltd.
- Lifecore PrimaConnexTM Internal Connection Implant System(K051614) by Lifecore Biomedical, Inc.
- Xpeed AnyRidge Internal Implant System (K140091) by MegaGen Implant Co., Ltd.
- 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.

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Image /page/5/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is primarily blue and features the word "Abutment" in a stylized font. Below the word "Abutment" is a design that resembles a screw or bolt, also in blue. The logo is simple and modern, with a focus on the company name and a visual element related to engineering or construction.

#### General Description

#### TruAbutment DS

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for prosthetic restoration. The subject abutments are indicated for cemented or screw-retained restorations. The patient-specific abutment screw are made of Titanium grade Ti-6A1-4V ELI (meets ASTM Standard F-136). Each patient-specific abutment is supplied with two identical screws which are used for:

- (1) For fixing into the endosseous implant
- (2) For dental laboratory use during construction of related restoration.

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

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

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

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

| TruAbutment Platform Diameter /<br>Compatible Implant System | TruAbutment DS<br>Engaging | TruAbutment DS<br>Non-Engaging |
|--------------------------------------------------------------|----------------------------|--------------------------------|
| Astra Tech OsseoSpeed (K101732, K024111) | | |
| X-small | o | o |
| Small | o | o |
| Large | o | o |
| Dentium SuperLine (K041368) | | |
| Regular | o | o |
| Keystone PrimaConnex (K051614) | | |
| 3.5 (SD) | o | o |
| 4.1 (RD) | o | o |
| 5.0 (WD) | o | o |
| Straumann Bone Level (K162890) (K140878) | | |
| SC | o | o |
| NC | o | o |
| RC | o | o |

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Image /page/6/Picture/0 description: The image is a logo for Abutment. The logo is blue and white. The word "Abutment" is written in white letters on a blue background. Below the word "Abutment" is a blue image that looks like a screw.

## Design Limitation for TruAbutment DS

| Design parameter | Design Limit |
|------------------------------------------------------------------------------------------------------|---------------|
| Minimum and Maximum abutment angle | 0~25° |
| Minimum and Maximum Cuff Height | 0.5~6.0mm |
| Minimum and Maximum diameter at the<br>abutment/implant interface | Ø3.8mm~Ø8.0mm |
| Minimum Thickness | 0.4 mm |
| Minimum and Maximum length of<br>abutment post (length above the abutment<br>collar/gingival height) | 4~7 mm |

## TruBase S

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

TruBase abutments are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications and are provided in various prosthetic platform diameters (Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro: X-small, Large and Dentium Company Limited Implantium: Regular and PrimaConnex™ Internal Connection Implant System: 3.5, 4.1, 5.0 and Straumann Ø2.9 mm Bone Level Tapered Implants: Small Crossfit (SC) and Straumann® Bone Level Tapered Implants: Narrow Crossfit (NC), Regular Crossfit (RC) and Xpeed AnyRidge Internal Implant System: 4.0, 4.4, 4.9, 5.4, 5.9 (3.5).

CAD/CAM customized superstructure that composes the final abutment must be designed and milled through the 3Shape Abutment Designer Software, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase in the lab. Use "RelyX Unicem 2Automix" as an adhesive extra orally to connect.

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

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

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

| TruAbutment Platform Diameter /<br>Compatible Implant System | TruBase<br>Engaging | TruBase<br>Non-Engaging |
|--------------------------------------------------------------|---------------------|-------------------------|
| Astra Tech OsseoSpeed (K101732, K024111) | | |
| X-small | o | o |
| Small | o | o |
| Large | o | o |
| Dentium SuperLine (K041368) | | |
| Regular | o | o |

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Image /page/7/Picture/0 description: The image shows a logo for "Abutment.ru". The logo is in blue and features the word "Abutment" in a stylized font. Below the word "Abutment" is the ".ru" domain name, also in blue. The logo has a screw-like design on the left side of the ".ru" domain name.

| TruAbutment Platform Diameter /<br>Compatible Implant System | TruBase<br>Engaging | TruBase<br>Non-Engaging |
|--------------------------------------------------------------|---------------------|-------------------------|
| Keystone PrimaConnex (K051614) | | |
| 3.5 (SD) | o | o |
| 4.1 (RD) | o | o |
| 5.0 (WD) | o | o |
| Straumann Bone Level (K162890) (K140878) | | |
| SC | o | o |
| NC | o | o |
| RC | o | o |
| Megagen AnyRidge (K140091) | | |
| 3.5 | o | o |

#### Raw material blanks

- InCoris Zi (ZrO2) by Sirona Dental Systems GmbH, L size blanks, cleared under K123664. .
## Cement

- . RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.
## Software

- 3Shape Abutment Designer Software by 3Shape A/S, cleared under K151455. ●
## Instruments

- Screwdrivers (class I exempt devices) ●
- . Scanbodies (class I – exempt devices)

## Design Limitation for Zirconia superstructure

| Design parameter | Design Limit |
|------------------------------------------------------------------------------------------------------|------------------------------------------|
| Minimum and Maximum abutment angle | 0~15° |
| Minimum and Maximum Cuff Height | 0.5~5 mm |
| Minimum and Maximum diameter at the<br>abutment/implant interface | $\varnothing$ 5.0mm~ $\varnothing$ 8.0mm |
| Minimum Thickness | 0.4 mm |
| Minimum and Maximum length of<br>abutment post (length above the abutment<br>collar/gingival height) | 4~6 mm |

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Image /page/8/Picture/0 description: The image shows a logo for "Abutment.ru". The logo is in blue and features the word "Abutment" in a sans-serif font, with the "A" slightly larger than the other letters. Below the word "Abutment" is the text ".ru" in a larger, stylized font. To the left of the text is a graphic that resembles a screw or bolt.

#### Indication for Use

## TruAbutment DS

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

- · Astra Tech Implant System (K101732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)
- · Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular)
- · PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)
- · Straumann Ø2.9 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)

All digitally designed abutments and/or coping for use with the TruAbutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

## TruBase

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

- · Astra Tech Implant System (K101732), Astra Tech OsseoSpeed, Astra Tech Fixture MicroMacro (New Indication) (K024111): 3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large)
- · Dentium Company Limited Implantium (K041368): 3.4, 3.8, 4.3, 4.8 (Regular)
- · PrimaConnex™ Internal Connection Implant System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD)
- · Straumann Ø2.9 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)
- · Xpeed AnyRidge Internal Implant System (K140091): 4.0, 4.4, 4.9, 5.4, 5.9 (3.5)

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

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Image /page/9/Picture/0 description: The image shows a logo with the word "ABUTMENT" in white letters on a blue background. The "A" in "ABUTMENT" is larger than the other letters. Below the word "ABUTMENT" are the letters "ru" in a stylized font, also in blue. The left side of the logo has a jagged edge, resembling the threads of a screw.

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

| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length<br>(mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
|-----------------------------------------------------------------------|-------------------------------------|---------------------------|--------------------|-----------------------------------------|-----------------------------------------|
| Astra Tech<br>OsseoSpeed<br>TX<br>(K101732)<br>(K024111) | 3.0 S | 11 | 24982 | 3.0<br>(X-small) | Image: Internal double hexagon. |
| | | 13 | 24983 | | |
| | | 15 | 24984 | | |
| | 3.5 S | 8 | 24930 | 3.5/4.0<br>(Small) | |
| | | 9 | 24931 | | |
| | | 11 | 24932 | | |
| | | 13 | 24933 | | |
| | | 15 | 24934 | | |
| | 4.0 S | 17 | 24935 | 4.5/5.0<br>(Large) | |
| | | 8 | 24930 | | |
| | | 9 | 24931 | | |
| | | 11 | 24932 | | |
| | | 13 | 24933 | | |
| | 4.5 | 15 | 24934 | | |
| | | 17 | 24935 | | |
| | | 9 | 24951 | | |
| | | 11 | 24952 | | |
| | 13 | 24953 | | | |
| | 15 | 24954 | | | |
| | 17 | 24955 | | | |
| 5.0 | 9 | 24961 | 4.5/5.0<br>(Large) | | |
| | 11 | 24962 | | | |
| | 13 | 24963 | | | |
| | 15 | 24964 | | | |
| | 17 | 24965 | | | |
| 5.0 S | 2 | 24971 | | | |
| | 11 | 24972 | | | |
| | 13 | 24973 | | | |
| | 15 | 24974 | | | |
| | 17 | 24975 | | | |
| Dentium<br>SuperLine<br>(K041368) | 3.4 | 8 | FX3608SWC | Regular | |
| | | 10 | FX3610SWC | | |
| | | 12 | FX3612SWC | | |
| | | 14 | FX3614SWC | | |
| | 3.8 | 8 | FX4008SWC | | |
| | | 10 | FX4010SWC | | |
| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length<br>(mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
| | 4.3 | 12 | FX4012SWC | | Internal Hex |
| | | 14 | FX4014SWC | | |
| | | 8 | FX4508SWC | | |
| | | 10 | FX4510SWC | | |
| | | 12 | FX4512SWC | | |
| | | 14 | FX4514SWC | | |
| | 4.8 | 8 | FX5008SWC | | |
| | | 10 | FX5010SWC | | |
| | | 12 | FX5012SWC | | |
| | | 14 | FX5014SWC | | |
| | | 8 | FX6008SWC | | |
| | | 10 | FX6010SWC | | |
| | 4.8 | 12 | FX6012SWC | | |
| | 3.5 | 10 | 15413K | 3.5<br>(SD) | Internal TiLobe |
| | | 11.5 | 15414K | | |
| | | 13 | 15415K | | |
| | | 15 | 15416K | | |
| Keystone<br>PrimaConnex<br>(K051614) | 4.1 | 10 | 15417K | 4.1<br>(RD) | |
| | | 11.5 | 15418K | | |
| | | 13 | 15419K | | |
| | | 15 | 15415K | | |
| | 5.0 | 10 | 15421K | 5.0<br>(WD) | |
| | | 11.5 | 15422K | | |
| | | 13 | 15423K | | |
| | | 15 | 15424K | | |
| Straumann<br>Bone Level<br>Tapered<br>Implants<br>SC<br>(K162890) | 2.9 | 10 | 021.0010 | Small<br>Crossfit<br>(SC) | Internal Cross Fit® |
| | | 12 | 021.0112 | | |
| | | 14 | 021.0114 | | |
| Straumann<br>Bone Level<br>Tapered<br>Implants<br>NC, RC<br>(K140878) | 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 | | |
| | 4.1 | 8 | 021.5508 | | |
| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length<br>(mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
| Megagen<br>AnyRidge®<br>(K140091) | 4.8 | 10 | 021.5510 | Regular<br>Crossfit<br>(RC) | |
| | | 12 | 021.5512 | | |
| | | 14 | 021.5514 | | |
| | | 16 | 021.5516 | | |
| | | 18 | 021.5518 | | |
| | | 8 | 021.7508 | | |
| | | 10 | 021.7510 | | |
| | | 12 | 021.7512 | | |
| | | 14 | 021.7514 | | |
| | | 16 | 021.7516 | | |
| | | 18 | 021.7518 | | |
| | | 7 | FANIHX3507C | | |
| 4.0 | 8 | FANIHX3508C | 3.5 | Image: Internal Hex | |
| | 10 | FANIHX3510C | | | |
| | 11.5 | FANIHX3511C | | | |
| | 13 | FANIHX3513C | | | |
| | 15 | FANIHX3515C | | | |
| | 7 | FANIHX4007C | | | |
| 4.4 | 8 | FANIHX4008C | | | |
| | 10 | FANIHX4010C | | | |
| | 11.5 | FANIHX4011C | | | |
| | 13 | FANIHX4013C | | | |
| | 15 | FANIHX4015C | | | |
| | 7 | FANIHX4508C | | | |
| 4.9 | 8 | FANIHX4508C | | | |
| | 10 | FANIHX4510C | | | |
| | 11.5 | FANIHX4511C | | | |
| | 13 | FANIHX4513C | | | |
| | 15 | FANIHX4515C | | | |
| | 7 | FANIHX5007C | | | |
| 5.4 | 8 | FANIHX5008C | | | |
| | 10 | FANIHX5010C | | | |
| | 11.5 | FANIHX5011C | | | |
| | 13 | FANIHX5013C | | | |
| | 15 | FANIHX5015C | | | |
| | 7 | FANIHX5507C | | | |
| 5.9 | 8 | FANIHX5508C | | | |
| Implant<br>System | Implant<br>Body<br>Diameter<br>(mm) | Implant<br>Length<br>(mm) | Model No. | Implant<br>Platform<br>Diameter<br>(mm) | Type of Implant-<br>Abutment Connection |
| | | 10 | FANIHX5510C | | |
| | | 11.5 | FANIHX5511C | | |
| | | 13 | FANIHX5513C | | |
| | | 15 | FANIHX5515C | | |

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The letter "A" is larger than the other letters, and the letters "ru" are connected and larger than the rest of the word.

## TruAbutment Inc. 17742 Cowan, Irvine, CA 92614

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The letter "A" is larger than the other letters, and the letters "ru" are connected and stylized to look like a single shape.

## TruAbutment Inc. 17742 Cowan, Irvine, CA 92614

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows a logo for a company called "ABUTMENT". The logo is blue and white, with the word "ABUTMENT" in a stylized font. The letter "A" is larger than the other letters, and the letters "ru" are connected and stylized to look like a screw. The logo is simple and modern, and it is likely used to represent a company that specializes in dental implants or other dental products.

## TruAbutment Inc. 17742 Cowan, Irvine, CA 92614

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows a logo with the word "ABUTMENT" in a stylized font. The letters are in a bright blue color. The logo also includes a graphic element that resembles a screw or bolt head, also in blue. The overall design is simple and modern.

## Summary of Technological Characteristics

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

#### TruAbutment DS

| Attributes | Proposed Device | Primary Predicate Device |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | TruAbutment DS | TruAbutment DS (K201197) |
| Indications for Use | TruAbutment DS is a patient-specific CAD/CAM<br>abutment, directly connected to endosseous dental<br>implants and is intended for use as an aid in prosthetic<br>rehabilitation. It is compatible with the following<br>systems: | TruAbutment DS is a patient-specific CAD/CAM<br>abutment, directly connected to endosseous dental<br>implants and is intended for use as an aid in prosthetic<br>rehabilitation. It is compatible with the following systems: |
| | Astra Tech Implant System (K101732), Astra Tech OsseoSpeed,<br>Astra Tech Fixture MicroMacro (New Indication) (K024111):<br>3.0S, 3.5S, 4.0S, 4.5, 5.0, 5.0S (X-Small, Small, Large) | Zimmer 3.1mmD Dental Implant System (K142082)<br>Screw Vent® and Tapered Screw Vent® (K013227)<br>Nobel Active 3.0 (K102436)<br>Nobel Active Internal Connection Implant (K071370) |
| | Dentium Company Limited Implantium (K041368): 3.4, 3.8,<br>4.3, 4.8 (Regular) | All digitally designed abutments and/or coping for use<br>with the TruAbutment DS abutments are intended to be<br>sent to a TruAbutment-validated milling center for<br>manufacture. |
| | PrimaConnex™ Internal Connection Implant<br>System(K051614): 3.5, 4.1, 5.0 (SD, RD, WD) | TruAbutment DS is compatible with the following<br>devices:<br>Zimmer 3.1mmD Dental Implant System(K142082)<br>Implant Body Diameter 3.1/ Implant Platform Diameter<br>2.9 / Internal Hex<br><br>Screw Vent® and Tapered Screw Vent® (K013227) |
| | Straumann Ø2.9 mm Bone Level Tapered Implants, SC<br>CARES Abutments (K162890): 2.9 (SC) | |
| | Straumann® Bone Level Tapered Implants (K140878): 3.3,<br>4.1, 4.8 (NC, RC) | |
| | All digitally designed abutments and/or coping for use<br>with the TruAbutment DS abutments are intended to be<br>sent to a TruAbutment-validated milling center for | |
| | manufacture. | |
| Attributes | Proposed Device | Primary Predicate Device |
| Trade Name | TruAbutment DS | TruAbutment DS (K201197) |
| | | Implant Body Diameter 3.7/ Implant Platform Diameter 3.5 / Internal Hex |
| | | Implant Body Diameter 4.1/ Implant Platform Diameter 3.5 / Internal Hex |
| | | Implant Body Diameter 4.7/ Implant Platform Diameter 4.5 / Internal Hex |
| | | Implant Body Diameter 6.0/ Implant Platform Diameter 5.7 / Internal Hex |
| | | Nobel Active 3.0 (K102436)<br>Implant Body Diameter 3.0/ Implant Platform Diameter 3.0/ Internal Hex |
| | | Nobel Active Internal Connection Implant (K071370)<br>Implant Body Diameter 3.5/ Implant Platform Diameter NP / Internal Hex |
| | | Implant Body Diameter 4.3/ Implant Platform Diameter RP / Internal Hex |
| | | Implant Body Diameter 5.0/ Implant Platform Diameter RP / Internal Hex |
| | | Implant Body Diameter 5.5/ Implant Platform Diameter WP / Internal Hex |
| CAD Design Limits | Minimum and Maximum abutment angle: 0~25°<br>Minimum and Maximum Gingival (Cuff) Height: 0.5~6.0mm<br>Minimum and Maximum diameter at abutment/implant interface:<br>$Ø3.8~Ø8.0$<br>Minimum and Maximum length of abutment: 6~11mm<br>Minimum wall thickness at the abutment/implant interface: 0.4mm<br>Minimum and Maximum length of abutment post (length above the abutment collar/gingival height): 4~8mm | Minimum and Maximum abutment angle: 0~25°<br>Minimum and Maximum Gingival (Cuff) Height: 0.5~4.0mm<br>Minimum and Maximum diameter at abutment/implant interface:<br>$Ø3.8~Ø5.5$<br>Minimum and Maximum length of abutment: 6~11mm<br>Minimum wall thickness at the abutment/implant interface: 0.4mm<br>Minimum and Maximum length of abutment post (length above the abutment collar/gingival height): 4~7mm |
| Attributes | Proposed Device | Primary Predicate Device |
| Trade Name | TruAbutment DS | TruAbutment DS (K201197) |
| Connection | Internal Connections | Internal Connections…