TruAbutment DS, TruBase

K213961 · Truabutment, Inc. · NHA · Jul 14, 2022 · Dental

Device Facts

• Record ID: K213961
• Device Name: TruAbutment DS, TruBase
• Applicant: Truabutment, Inc.
• Product Code: NHA · Dental
• Decision Date: Jul 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 custom 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; they connect to endosseous dental implants to support prosthetic restorations (crowns/copings). TruAbutment DS is a single-piece CAD/CAM abutment; TruBase is a two-piece system consisting of a titanium base and a CAD/CAM-designed zirconia superstructure. Inputs include patient intra-oral data; CAD/CAM systems design the abutment/superstructure; manufacturing occurs at a validated milling center. The device is used in dental clinics; operated by dentists/prosthodontists. The healthcare provider secures the abutment to the implant using a titanium screw. The output provides a stable foundation for dental prosthetics, restoring chewing function and aesthetics. Benefits include patient-specific fit and functional rehabilitation.

Clinical Evidence

Bench testing only. Evidence includes ISO 14801 fatigue testing on worst-case constructs, dimensional analysis, and reverse engineering to confirm compatibility with OEM implant systems. Biocompatibility and sterilization validation were leveraged from the predicate device (K203649). MRI safety was evaluated via scientific rationale and literature review.

Technological Characteristics

Materials: Ti-6Al-4V ELI (ASTM F136). Design: Patient-specific CAD/CAM machined abutments. Connection: Internal hex/spline interfaces. Sterilization: Non-sterile, requires end-user moist steam sterilization (ISO 17665). Connectivity: Compatible with specific OEM implant systems (Osstem, Astra, BioHorizons, Straumann).

Indications for Use

Indicated for patients requiring prosthetic rehabilitation via endosseous dental implants. TruAbutment DS is for patient-specific CAD/CAM abutments. TruBase is for screw-retained or cement-retained single tooth and 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 (K203649)

Reference Devices

• Osstem TS Fixture System (K121995)
• Astra OsseoSpeed EV (K120414)
• Biohorizons Laser-Lok 3.0 Implant System (K093321)
• Biohorizons Tapered Internal Implants (K143022)
• Biohorizons Tapered Internal Implant System (K071638)
• Straumann Tissue Level Implant (K122855)
• Straumann 4mm Short Implants (K202942)
• InCoris Zi (K123664)
• RelyX Unicem 2Automix (K100756)

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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

TruAbutment Inc. Chris Choi Director 17666 Fitch Irvine, California 92614

Re: K213961

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: June 10, 2022 Received: June 17, 2022

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 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) K213961

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:

• Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm

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 (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Indications for Use

510(k) Number (if known) K213961

Device Name TruAbutment DS, TruBase

#### Indications for Use (Describe)

TruBase

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

- · Osstem TSIII SA (K121995) 3.5 (3.7) , 4.0 (4.2) , 4.5 (4.6) , 5.0 (5.1) , 6.0 (6.0) , 7.0 (6.8) mm (Mini, Regular)
- · Astra OsseoSpeed EV (K120414) 3.6, 4.2, 4.8, 5.4 mm
- · BioHorizon Tapered Internal(K093321, K143022, K071638) 3.0. 3.4, 3.8 mm
- · Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm

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) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CER 801 Subpart D) </span> </div> | <div> <span> □ Over-The-Counter Use (21 CER 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

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

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

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

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Image /page/4/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, with the "A" in uppercase and the rest of the word in lowercase. Below "Abutment", there is a stylized image of a screw or bolt, also in blue. The logo has a modern and professional look.

# 510(k) Summary K213961

Submitter TruAbutment Inc. Kiyoon Nam 17666 Fitch, Irvine, CA 92614 USA Email: [e-mail] Phone: [phone]

## Official Correspondent

TruAbutment Inc. Chris Choi 17666 Fitch, 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: 07/13/2022 ●

#### Predicate Devices/ Reference Devices:

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

#### Primary Predicate:

- TruAbutment DS (K203649) by TruAbutment Inc. ●
#### Reference Devices for OEM Compatibilities:

- Osstem TS Fixture System(K121995) by Osstem Implant Co., Ltd.
- Astra OsseoSpeed EV (K120414) by Astra. ●
- Biohorizons Laser-Lok 3.0 Implant System (K093321) by Biohorizons Implant Systems, Inc. ●
- Biohorizons Tapered Internal Implants (K143022) by Biohorizons Implant Systems, Inc.
- Biohorizons Tapered Internal Implant System (K071638) by Biohorizons Implant Systems, Inc.
- . Straumann Tissue Level Implant (K122855) by Straumann USA.
- Straumann 4mm Short Implants (K202942) by Straumann USA. ●

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Image /page/5/Picture/0 description: The image is a logo for a company called "Abutment ru". The logo is in blue and white. The word "Abutment" is in white letters on a blue background. The letters "ru" are in blue and are larger than the word "Abutment". The logo has a stylized image of a screw.

#### General Description

#### TruAbutment DS

TruAbutment DS system includes patient-specific abutments which are placed into the dental implant to provide support for the 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.

Design Limitation for TruAbutment DS

| Design Parameter | Design Limit |
|----------------------------------------------------------------------------------------------------------|--------------|
| Minimum and Maximum abutment angle(°) | 0~25 |
| Minimum and Maximum cuff height(mm) | 0.5 ~ 6.0 |
| Minimum and Maximum diameter at abutment/implant interface(Ø,mm) | 5.2 ~ 8.0 |
| Minimum thickness(mm) | 0.4 |
| Minimum and Maximum length of abutment post<br>(length above the abutment collar / gingival height) (mm) | 4.0~7.0 |

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Image /page/6/Picture/0 description: The image shows a logo for a company called "Abutment ru". The word "Abutment" is in white text with a blue outline, and the letters are capitalized. Below the word "Abutment" is the word "ru" in a large, stylized blue font. To the left of the word "ru" is a graphic of a tooth.

## TruBase

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. The system also includes a TruBase Screw for fixation to the implant body.

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 a various prosthetic platform diameters (OSSTEM TSIII SA 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular) and Astra EV 3.6, 4.2, 4.8, 5.4mm and BioHorizons Internal 3.0. 3.5. 4.5. 5.7mm and Straumann Tissue Level: 4.1(RN), 4.8(RN), 6.5(WN). The TruBase Screws are composed of titanium alloy per ASTM F136.

CAD/CAM customized superstructure that composes the final abutment intended to be sent to a TruAbutment-validated milling center to be designed and milled, according to the prosthetic planning and patient clinical situation. The superstructure is cemented to the TruBase 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.

## Raw material blanks

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

- RelyX Unicem 2Automix by 3M ESPE, cleared under K100756.
## Design Limitation for Zirconia superstructure

| Design parameter | Design Limit |
|------------------------------------------------------------------------------------------------------|----------------------|
| Minimum and Maximum abutment angle | 0~15° |
| Minimum and Maximum Cuff Height | 0.5~5 mm |
| Minimum and Maximum diameter at<br>abutment/implant interface | $Ø$ 6.5mm~ $Ø$ 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/7/Picture/0 description: The image shows a logo for a company called "Abutment". The logo is in blue and features the word "Abutment" in a stylized font. Below the word "Abutment" is a graphic that resembles a screw or bolt. The logo is simple and modern, and the blue color gives it a professional look.

#### Indication for Use

## TruAbutment DS

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

- Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm
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 custom prosthetic restorations, such as copings or crowns. It is indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. It is compatible with the following systems:

- Osstem TSIII SA (K121995): 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0 (6.0), 7.0 (6.8) (Mini, Regular)
- Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm
- BioHorizons Tapered Internal (K093321, K143022, K071638) 3.0, 3.4, 3.8, 4.6, 5.8 mm ●
- Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5(WN) mm ●

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

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Image /page/8/Picture/0 description: The image features a logo with the word "ABUTMENT" in white, set against a blue background. The "ru" is stylized in a cursive font and is also in blue. To the left of the text, there is a graphic of a screw, also in blue, which adds a visual element related to construction or engineering.

# TruAbutment DS and TruBase 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 |
|-------------------------------------------------------------------------|-------------------------------------|------------------------|-----------|-----------------------------------------|-----------------------------------------|
| OSSTEM<br>TSIII<br>SA (K121995) | 3.5 (3.7) | 8.5mm | TS3M3508S | 2.1<br>(Mini) | Image: Internal Hex |
| | | 10mm | TS3M3510S | | |
| | | 11.5mm | TS3M3511S | | |
| | | 13mm | TS3M3015S | | |
| | 4.0 (4.2) | 7mm | TS3S4007S | 2.5<br>(Regular) | |
| | | 8.5mm | TS3S4008S | | |
| | | 10mm | TS3S4010S | | |
| | | 11.5mm | TS3S4011S | | |
| | 4.5 (4.6) | 13mm | TS3S4013S | | |
| | | 7mm | TS3S4507S | | |
| | | 8.5mm | TS3S4508S | | |
| | | 10mm | TS3S4510S | | |
| | 5.0 (5.1) | 11.5mm | TS3S4511S | | |
| | | 13mm | TS3S4513S | | |
| | | 7 mm | TS3S5007S | | |
| | | 8.5 mm | TS3S5008S | | |
| | 10 mm | TS3S5010S | | | |
| | 11.5 mm | TS3S5011S | | | |
| 13 mm | TS3S5013S | | | | |
| 6.0 (6.0) | 7 mm | TS3S6007S | | Image: Internal Spline | |
| | 8.5 mm | TS3S6008S | | | |
| | 10 mm | TS3S6010S | | | |
| | 11.5 mm | TS3S6011S | | | |
| 13 mm | TS3S6013S | | | | |
| 7.0 (6.8) | 7 mm | TS3S7007S | | | |
| | 8.5 mm | TS3S7008S | | | |
| | 10 mm | TS3S7010S | | | |
| | 11.5 mm | TS3S7011S | | | |
| 13 mm | TS3S7013S | | | | |
| Astra<br>OsseoSpeed<br>EV<br>(K120414) | 3.6 | 6mm | 25221 | 3.6 | |
| | | 8mm | 25222 | | |
| | | 9mm | 25223 | | |
| | | 11mm | 25224 | | |
| | | 13mm | 25225 | | |
| | | 15mm | 25226 | | |
| | | 17mm | 25227 | | |
| 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 |
| | 4.2 | 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 | | |
| | 3.0 | 10.5mm | TLX3010 | 3.0 | |
| | | 12mm | TLX3012 | | |
| | | 15mm | TLX3015 | | |
| BioHorizons<br>Tapered<br>Internal<br>(K093321,<br>K143022,<br>K071638) | 3.4 | 9mm | TLX3409 | 3.0 | |
| | | 10.5mm | TLX3410 | | |
| | | 12mm | TLX3412 | | |
| | | 15mm | TLX3415 | | |
| | 3.8 | 18mm | TLX3418 | 3.5 | |
| | | 9mm | TLX3809 | | |
| | | 10.5mm | TLX3810 | | |
| | | 12mm | TLX3812 | | |
| | | 15mm | TLX3815 | | |
| | 4.6 | 18mm | TLX3818 | 4.5 | |
| | | 7.5mm | TLX4607 | | |
| | | 9mm | TLX4609 | | |
| | | 10.5mm | TLX4610 | | |
| | | 12mm | TLX4612 | | |
| 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 |
| | 5.8 | 15mm | TLX4615 | 5.7 | |
| | | 18mm | TLX4618 | | |
| | | 7.5mm | TLX5807 | | |
| | | 9mm | TLX5809 | | |
| | | 10.5mm | TLX5810 | | |
| | | 12mm | TLX5812 | | |
| | | 15mm | TLX5815 | | |
| | | 18mm | TLX5818 | | |
| | 4.1 | 6mm | 033.560S | Regular Neck<br>(RN) | Internal octagon |
| | | 8mm | 033.561S | | |
| | | 10mm | 033.562S | | |
| | | 12mm | 033.563S | | |
| | | 14mm | 033.564S | | |
| Straumann<br>Tissue Level<br>(K122855,<br>K202942) | 4.8 | 6mm | 033.590S | | |
| | | 8mm | 033.591S | | |
| | | 10mm | 033.592S | | |
| | | 12mm | 033.593S | | |
| | | 14mm | 033.594S | | |
| | 6.5 | 6mm | 033.610S | Wide Neck<br>(WN) | |
| | | 8mm | 033.611S | | |
| | | 10mm | 033.612S | | |
| | | 12mm | 033.613S | | |

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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 letters are stylized, with the "A" being larger than the other letters. Below the word "ABUTMENT" are the letters "ru" in a similar blue color and font. The "r" is designed to look like a screw.

## TruAbutment Inc. 17666 Fitch, Irvine, CA 92614

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Image /page/10/Picture/0 description: The image shows a logo for a company called "Abutment.ru". The word "Abutment" is in a sans-serif font and is placed above the letters "ru", which are larger and stylized. To the left of the "ru" is a graphic that resembles a screw or implant, possibly indicating the company's focus on dental implants or related products. The logo is in a bright blue color.

## 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 letters are in a bright blue color. The bottom of the logo has a design that resembles the threads of a screw, also in blue.

#### 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 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 (K203649) |
| Indications for Use | TruAbutment DS is a patient-specific CAD/CAM abutment, directly<br>connected to endosseous dental implants and is intended for use as an<br>aid in prosthetic rehabilitation. It is compatible with the following<br>systems:<br>Straumann Tissue Level Implant (K122855, K202942)<br>: 4.1(RN), 4.8(RN), 6.5(WN) mm<br>All digitally designed abutments and/or coping for use with the<br>TruAbutment DS abutments are intended to be sent to a<br>TruAbutment-validated milling center for manufacture. | TruAbutment DS is a patient-specific CAD/CAM abutment, directly<br>connected to endosseous dental implants and is intended for use as an aid in<br>prosthetic rehabilitation. It is compatible with the following systems:<br>MIS C1 Conical Connection Implant (K172505, K112162)<br>: 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP)<br>Neodent Implant System - GM Helix (K163194, K180536)<br>: 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0(3.0)<br>Nobel Biocare Groovy Implants (K050258)<br>: 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0)<br>Straumann BLX Implant (K173961, K181703, K191256)<br>: 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB)<br>Straumann Tissue Level Implant (K111357)<br>: 3.3(NNC)<br>All digitally designed abutments and/or coping for use with the<br>TruAbutment DS abutments are intended to be sent to a TruAbutment-<br>validated milling center for manufacture. |

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Image /page/12/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 connected to a graphic that resembles a screw. The letters "ru" are also larger than the other letters in the word and are connected to the screw graphic. The text and graphic are all in a light blue color.

| Attributes | Proposed Device | Primary Predicate Device |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | TruAbutment DS | TruAbutment DS (K203649) |
| CAD Design<br>Limits | Minimum and Maximum abutment angle(°): 0~25<br>Minimum and Maximum gingival (cuff) height(mm): 0.5~6.0<br>Minimum and Maximum diameter at abutment/implant<br>interface(Ø,mm): 5.2~8.0<br>Minimum wall thickness: 0.4<br>Minimum and Maximum length of abutment post (length above the<br>abutment collar/gingival height(mm): 4.0~7.0 | Minimum and Maximum abutment angle(°): 0~25<br>Minimum and Maximum gingival (cuff) height(mm): 0.5~6.0<br>Minimum and Maximum diameter at abutment/implant interface(Ø,mm):<br>3.3~8.0<br>Minimum and Maximum length of abutment(mm): 6.0~11.0<br>Minimum wall thickness at the abutment/implant interface(mm): 0.4~0.9<br>Minimum and Maximum length of abutment post (length above the<br>abutment collar/gingival height(mm): 4.0~7.0 |
| Connection | Internal Connections | Internal Connections |
| Sterility | Packaged Non-sterile | Packaged Non-sterile |
| Material | Ti-6AI-4V ELI | Ti-6AI-4V ELI |
| Abutment<br>Seat | Sits on Taper | Sits on Taper |
| Anatomical | Oral Cavity | Oral Cavity |
| Construction | Machined | Machined |
| Type of<br>Retention | Screw-retained to the implant. The prosthesis can be cement-retained<br>to the abutment. | Screw-retained to the implant. The prosthesis can be cement-retained to the<br>abutment. |
| Attributes | Proposed Device | Predicate Device |
| Trade Name | TruBase | TruBase (K203649) |
| Indications<br>for Use | TruBase is a titanium component that is directly connected to endosseous<br>dental implants to provide support for custom prosthetic restorations, such<br>as copings or crowns. It is indicated for screw-retained single tooth or<br>cement-retained single tooth and bridge restorations. It is compatible with<br>the following systems:<br>Osstem TSIII SA (K121995): 3.5 (3.7), 4.0 (4.2), 4.5 (4.6), 5.0 (5.1), 6.0<br>(6.0), 7.0 (6.8) (Mini, Regular) Astra OsseoSpeed EV(K120414) 3.6, 4.2, 4.8, 5.4 mm BioHorizons Tapered Internal (K093321, K143022, K071638)<br>3.0, 3.4, 3.8, 4.6, 5.8 mm Straumann Tissue Level Implant (K122855, K202942): 4.1(RN), 4.8(RN), 6.5<br>(WN) mm All digitally designed zirconia superstructure for use with TruBase are<br>intended to be sent to a TruAbutment-validated milling center for<br>manufacture. | TruBase is a titanium component that is directly connected to<br>endosseous dental implants to provide support for patient-specific<br>prosthetic restorations, such as copings or crowns. It is indicated for<br>a screw-retained single tooth or cement-retained single tooth and<br>bridge restorations. It is compatible with the following systems:<br>MIS C1 Conical Connection Implant (K172505, K112162)<br>: 3.3 (NP) 3.75, 4.2, 5.0 (SP, WP) Neodent Implant System - GM Helix (K163194, K180536)<br>: 3.5, 3.75, 4.0, 4.3, 5.0 (3.0) 6.0(3.0) Nobel Biocare Groovy Implants (K050258)<br>: 3.5. 4.3, 5.0, 6.0 (NP, RP, WP, 6.0) Straumann BLX Implant (K173961, K181703, K191256)<br>: 3.5, 3.75, 4.0, 4.5, 5.0, 5.5, 6.5 (RB, WB) Straumann Tissue Level Implant (K111357)<br>: 3.3(NNC) All digitally designed zirconia superstructure for use with the<br>TruBase are intended to be sent to a TruAbutment-validated<br>milling center for manufacture. |
| CAD Design<br>Limits | Maximum Angulation 0~15°<br>Maximum Cuff Height 0.5~5mm<br>Minimum Diameter Ø 5.0~ Ø 8.0mm<br>Minimum Thickness 0.4mm<br>Minimum Post Height 4~6mm | Maximum Angulation (°): 0~15<br>Maximum cuff height(mm) 0.5~5.0<br>Minimum and Maximum diameter at the<br>abutment/implant(Ø,mm): 5.0~ 8.0<br>Minimum thickness(mm): 0.4<br>Minimum Post Height 4~6mm |
| Attributes | Proposed Device | Predicate Device |
| Trade Name | TruBase…