TruAbutment DS

K152559 · Truabutment · NHA · May 20, 2016 · Dental

Device Facts

• Record ID: K152559
• Device Name: TruAbutment DS
• Applicant: Truabutment
• Product Code: NHA · Dental
• Decision Date: May 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes. 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.

Device Story

TruAbutment DS is a patient-specific CAD/CAM custom dental abutment; used for screw-retained prosthetic restorations. Device consists of titanium (Ti-6Al-4V ELI) abutment and screw; connects to Osstem TS Fixture System implants via internal hex interface. Clinicians use CAD/CAM systems to design abutments based on patient intra-oral anatomy; designs sent to TruAbutment-validated milling center for fabrication. Final abutment placed over implant shoulder and secured with screw. System provides support for crowns, bridges, or overdentures; ensures mechanical stability of implant-abutment connection. Benefits include customized fit for prosthetic rehabilitation.

Clinical Evidence

Bench testing only. Included fatigue testing (ISO 14801:2007) on worst-case assembled implant/abutment systems (smallest diameter, maximum angulation), dimensional analysis, reverse engineering of connection platforms, and biocompatibility testing (ISO 10993-1, -5, -10). Steam sterilization validated per ISO 17665 and ANSI/AAMI ST79.

Technological Characteristics

Material: Titanium grade Ti-6Al-4V ELI (ASTM F-136). Connection: Internal hex. Interface sizes: 2.08mm (Mini) and 2.48mm (Regular). Manufacturing: CAD/CAM machined. Sterilization: Non-sterile (end-user steam sterilization).

Indications for Use

Indicated for use as an aid in prosthetic rehabilitation for patients requiring screw-retained restorations on Osstem TS Fixture System endosseous dental implants (Mini 2.08mm or Regular 2.48mm interface sizes).

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

• ET SmartFit Abutment (K123627)

Reference Devices

• Osstem TS Fixture System (K121995)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2016

TruAbutment, Inc. % Ms. April Lee Consultant WithUS Group Inc 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K152559

Trade/Device Name: TruAbutment DS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 15, 2016 Received: April 20, 2016

Dear Ms. Lee:

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. 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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Page 2 - Ms. April Lee

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K152559

Device Name TruAbutment DS

Indications for Use (Describe)

The TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes.

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)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

#### Submitter

TruAbutment Inc. Brandon Kim 300 S. Harbord Blvd #520 Anaheim, CA 92805 USA Email: [e-mail] Phone: [phone]

# Official Correspondent

WithUS Group Inc April Lee 2531 Pepperdale Drive, Rowland Heights, CA 9174 USA Email: [e-mail] Phone: [phone] Fax: [phone]

## Device Information

- Trade Name: TruAbutment DS
- 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: 5/18/2016 ●

## General Description

The TruAbutment DS system includes custom abutments which are placed into the dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for screwretained restorations. The custom abutment and abutment screw are made of Titamium grade Ti-6A1-4V ELI (meets ASTM Standard F-I 36) for Osstem TS Fixture System (K121995) which consists of both Mini and Regular interface sizes. Each custom 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 custom abutments take into consideration the shape of 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 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 proposed custom abutments are available in internal hex connection, and are compatible with the Osstem TS Fixture System implant bodies. The Osstem TS Fixture System consists of two interface hex

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| Implant System | Implant Diameter (mm) | Platform Connection Size<br>(mm) | Type of Implant-<br>Abutment Connection |
|---------------------------------------------|-----------------------|----------------------------------|-----------------------------------------|
| Osstem TS<br>Fixture System | 3.5 | 2.08 (Mini) | Internal Hex |
| | 4.0 | | Internal Hex |
| | 4.5 | | Internal Hex |
| | 5.0 | 2.48 (Regular) | Internal Hex |
| Osstem TS<br>Fixture System<br>(Ultra Wide) | 6.0 | | Internal Hex |
| | 7.0 | | Internal Hex |

sizes which are 2.08mm (Mini) and 2.48mm (Regular). The available range of diameters is summarized below:

## Indication for Use

The TruAbutment DS is a patient-specific CAD/CAM custom abutment, directly connected to endosseous dental implants and is intended for use as an aid in prosthetic rehabilitation. It is compatible with all diameters of the Osstem TS Fixture System which consists of Mini (2.08mm) and Regular (2.48mm) interface sizes.

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.

## 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.

## Non-clinical Testing

- . End User Steam Sterilization Test according to ISO 17665-1:2006, 17665-2:2009 and ANSI/AAMI ST79:2010.
- . Biocompatibility tests according to ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010.
- . Fatigue Test according to ISO 14801:2007

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

Non-clinical testing was conducted in accordance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments'', and it consisted of testing finished assembled implant/abutment systems of the worst case scenario, (smallest diameter with maximum angulation) through fatigue testing.

Dimensional analysis and reverse engineering of the implant-to-abutment connection platform were performed, including an assessment of maximum and minimum dimensions of critical design aspects, tolerances, and cross-sectional images of the submission device and compatible implant body as well as the OEM implant abutment and implant body. The testing demonstrated implant to abutment compatibility and has established substantial equivalency of the proposed device with predicate devices. Clinical testing was not necessary to establish substantial equivalency of the device.

# Predicate Devices:

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

- . ET SmartFit Abutment K123627
## Comparison between Predicate and Proposed Device

| Attributes | Proposed Device | Predicate Device |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | TruAbutment DS | ET SmartFit Abutment (K123627) |
| Indications for Use | The TruAbutment DS is a patient-<br>specific CAD/CAM custom abutment,<br>directly connected to endosseous dental<br>implants and is intended for use as an<br>aid in prosthetic rehabilitation. It is<br>compatible with all diameters of the<br>Osstem TS Fixture System which<br>consists of Mini (2.08mm) and Regular<br>(2.48mm) interface sizes.<br>All digitally designed abutments and/or<br>coping for use with the TruAbutment<br>DS abutments are intended to be sent to<br>a TruAbutment-validated milling center<br>for manufacture. | ET SmartFit Abutment is intended for use<br>with a dental implant to provide support<br>for prosthetic restorations such as crowns,<br>bridges, or overdentures. |
| Dimensions | Interface Hex Size:<br>Mini (2.08 mm) and Regular (2.48<br>mm) | Interface Hex Size:<br>Mini (2.08 mm) and Regular (2.48 mm) |
| Connection | Internal Hex | Internal Hex |
| Sterility | Packaged Non-sterile | Packaged Non-sterile |
| Material | Ti-6AI-4V ELI | Ti-6AI-4V ELI |
| Picture of Abutment | (Milled from rods) | (Milled from puck) |
| | Mini | Mini |
| | Image: Regular abutment | Image: Regular abutment |
| | Image: Regular abutment | Image: Regular abutment |
| Picture of Screw | Image: Mini screw | Image: Mini screw |
| | Image: Regular screw | Image: Regular screw |
| | Image: Regular screw | Image: Regular screw |
| Abutment Angle ° | 0~25 | 0~30 |
| Abutment Seat | Sits on Taper | Sits on Taper |
| Screw Seat | Sits on Taper | Sits on Taper |
| Anatomical Site | Oral Cavity | Oral Cavity |
| Construction | Machined | Machined |
| Type of Retention | Screw-retained to the implant. The<br>prosthesis can be cement-retained to<br>the abutment. | Screw-retained to the implant. The<br>prosthesis can be cement-retained to the<br>abutment. |

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## Substantial Equivalence Discussion

TruAbutment DS incorporates the same material, similar indications for use, dimension, design, abutment seat, screw seat, anatomical site, connection, type of retention and technological characteristics as the predicate device.

The Indications for Use of the subject and predicate devices feature different language or wording. However, both the subject and predicate device share intended use, namely to serve as an aid in prosthetic reconstructions, such as crowns, bridges or overdentures. Also both the predicate and subject devices are intended to be milled into patient specific abutments using CAD/CAM technology under the manufacturing control of the sponsor.

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The only other difference between the subject device and primary predicate is the manufacturing process and the maximum angulation of the abutment design. While the industry standard for CAD/CAM abutment is usually 30°, TruAbutment placed limitation on the abutment design at 25°in order to limit instances of having to re-design extraordinarily long abutments where the head protrudes from of the 14 mm () titanium rods. Other than this difference, there aren't any further variations between the two devices which would anyway impede the substantially equivalent decision.

Any differences in technology characteristics are accompanied by information that demonstrated the device is substantially equivalent as the predicate and do not raise different questions of safety and effectiveness than the predicate.

#### Conclusion

The TruAbutment DS constitutes a substantially equivalent medical device, meeting all the declared requirements of its intended use. This system has the same intended use and fundamental scientific technology as its predicate device. Therefore, TruAbutment DS and its predicate are substantially equivalent.