ST Internal Fixture System

K152787 · T-Plus Implant Tech. Co., Ltd. · DZE · Jul 22, 2016 · Dental

Device Facts

• Record ID: K152787
• Device Name: ST Internal Fixture System
• Applicant: T-Plus Implant Tech. Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Jul 22, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ST Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. The ST Internal Fixture System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Device Story

ST Internal Fixture System consists of Grade 4 titanium root-form dental implants, abutments, and screws. Used by dentists in clinical settings to replace missing teeth; implants are surgically placed into the upper or lower jawbone. System supports prosthetic devices (artificial teeth) via screw or cement retention. Provides immediate loading capability when primary stability is sufficient. Benefits include restoration of chewing function and aesthetic support. Device is purely mechanical; no software or electronic components.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical bench testing, including fatigue testing (ISO 14801), biocompatibility (cytotoxicity, sensitization, systemic toxicity, 90-day bone implantation), and surface cleaning validation (SEM/EDX).

Technological Characteristics

Materials: Grade 4 titanium. Surface treatment: Resorbable Blast Media (RBM). Connection: Internal hex. Sterilization: Gamma irradiation. Dimensions: Diameters 3.5-5.0mm, lengths 7.0-15.0mm. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw to support prosthetic devices (e.g., artificial teeth) and restore chewing function. Suitable for single or two-stage surgical procedures and immediate loading when primary stability and appropriate occlusal loading are achieved.

Regulatory Classification

Identification

An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• Ti Star Implant System (K132992)
• ExFeel Dental Implant System (K052369)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and 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

July 22, 2016

T-Plus Implant Tech. Co., Ltd. Dana Cheng Ouality Assurance No. 41, Wuquan 6th Rd., Wugu Dist., New Taipei City, 24889 TAIWAN

Re: K152787

Trade/Device Name: ST Internal Fixture System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: June 17, 2016 Received: June 21, 2016

Dear Dana Cheng:

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.

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

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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 (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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T-Plus Implant Tech. Co., Ltd. 510(k) Notification

ST Internal Fixture System

#### Indications for Use

510(k) Number (if known): K152787 ST Internal Fixture System Device Name: Indications for Use:

The ST Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.

The ST Internal Fixture System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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ST Internal Fixture System

#### 510(k) Summary

| 5.1 | Type of Submission: | Traditional |
|-----|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.2 | Preparation Date: | 06/17/2016 |
| 5.3 | Submitter: | T-Plus Implant Tech. Co., Ltd.<br>No.41, Wuquan 6th Rd., Wugu Dist., New<br>Taipei City 24889, Taiwan (R.O.C)<br>Phone: [phone]<br>Fax: [phone]<br>Contact: Dana Cheng ([e-mail]) |

5.4 Identification of the Device: ST Internal Fixture System Proprietary/Trade name: Endosseous dental implant Classification Name: Device Classification: II Dental Panel: 872.3640 Regulation Number: DZE Primary Product code: Subsequent Product code: NHA

#### 5.5 Primary Predicate Device (K132992):

| Predicate Device Name: | Ti Star Implant System<br>T-Plus Implant Tech. Co., Ltd. |
|--------------------------|----------------------------------------------------------|
| Device Classification: | II |
| Review Panel: | Dental |
| Regulation Number: | 872.3640 |
| Primary Product code: | DZE |
| Subsequent Product code: | NHA |

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ST Internal Fixture System

| 5.6 | Reference Predicate Device (K052369): | |
|------------------------|---------------------------------------|--|
| Predicate Device Name: | ExFeel Dental Implant System | |
| Manufacturer: | MegaGen Co., Ltd. | |
| Device Classification: | II | |
| Review Panel: | Dental | |
| Regulation Number: | 872.3640 | |
| Product Code: | DZE | |

#### 5.7 Intended Use and Indications for Use of the subject device

The ST Internal Fixture System is intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.

The ST Internal Fixture System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

#### 5.8 Device Description

The ST Internal Fixtures are made with Grade 4 titanium. The systems consist of one-stage and two-stage root form dental implants, associated with abutment systems, which provide the dentist with screw and cement retained restoration options.

The devices covered by this submission are ST internal fixture, screw and abutment. The diameters of ST internal fixtures are 3.5 mm, 4.0 mm, 4.5 mm, and 5.0 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm.

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| Component | Specification (mm) | | | | Angulation<br>range |
|---------------------|----------------------------|-----------|----------------------------|----------------------------|---------------------|
| | D | L | cuff | Post H | |
| ST Cover Screw | 3.15, 3.35,<br>3.7, 3.9 | N/A | N/A | 0.4, 2.0 | N/A |
| ST Healing screw | 4.0, 4.5, 5.0,<br>6.0, 7.0 | N/A | N/A | 3.0, 4.0, 5.0,<br>6.0, 7.0 | N/A |
| ST Abutment screw | 2.3, 2.5 | 10.8, 8.6 | N/A | N/A | N/A |
| ST EZ Post Abutment | 4.5, 5.0, 6.0,<br>7.0 | N/A | 1.0, 2.0, 3.0,<br>4.0, 5.0 | 4.0, 5.5, 7.0 | N/A |
| ST Solid Abutment | 4.0, 4.5, 5.0,<br>6.0, 7.0 | N/A | 1.0, 2.0, 3.0,<br>4.0, 5.0 | 4.0, 5.5, 7.0 | N/A |
| ST Angled Abutment | 4.0, 5.0, 6.0 | N/A | 1.0, 2.0, 3.0,<br>4.0, 5.0 | N/A | 15°, 25° |

The range of diameters and angulations for each screw model and abutment model are provided as below:

## 5.9 Non-clinical Testing

A series of tests were performed to assess the proposed device is substantially equivalent to the predicate devices. All the test results demonstrate that ST Internal Fixture System meets the requirements of its pre-defined acceptance criteria and intended use.

- > Sterilization Test (leveraged from own K132992 predicate)
- A Shelf Life Test (leveraged from own K052369 predicate)
- A Biocompatibility testing (leveraged from own K052369 predicate):
- Cytotoxicity Test ●
- Intracutaneous Reactivity Test
- . Maximization Sensitization Test
- . Systemic Injection Test (Intravenous Injection)
- Pyrogen Test ●
- . 90-Day Bone Implantation Study

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- > Performance testing:
- Fatigue test

A fatigue test is required to evaluate the stability of implant system in oral cavity. The fatigue testing has been conducted on the proposed device in accordance with ISO 14801. Test results comply with ISO14801. It approves the proposed device is substantially equivalent to the predicate devices.

- . RBM surface coating
ST Internal Fixtures and the predicate devices undergo an implant surface treatment of Resorbable Blast Media (RBM). The cleaning validation test and SEM/EDX analysis have been conducted on the proposed device to verify that any particles or chemicals used to remove particles have been washed from the surface.

#### 5.10 Clinical Testing

No additional clinical testing was necessary for a determination of substantial equivalence. The results of non-clinical testing indicated the device was found to be substantially equivalent to the predicate devices.

#### 5.11 Substantial Equivalence Determination

The ST Internal Fixture System submitted in this 510(k) file is substantially equivalent in main materials, implant surface treatment, angulation range, safety and performance claims to the cleared Ti Star Implant System (K132992) and ExFeel Dental Implant system (K052369). Differences of proposed device and predicate devices do not raise new issues of substantial equivalence.

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#### ST Internal Fixture System

| | Proposed device | Predicate device | Predicate device |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | ST Internal Fixture<br>system | Ti Star Implant System | ExFeel Dental<br>Implant System |
| Manufacturer | T-Plus Implant Tech.<br>Co., Ltd. | T-Plus Implant Tech.<br>Co., Ltd. | MegaGen Co., Ltd. |
| 510(k) Number | K152787 | K132992 | K052369 |
| Classification | Class II | Class II | Class II |
| Indication for Use | The ST Internal Fixture<br>System is intended to be<br>placed in the upper or<br>lower jaw to support<br>prosthetic devices, such<br>as artificial teeth, and to<br>restore a patient's<br>chewing function. This<br>may be accomplished<br>using either a two stage<br>surgical procedure or a<br>single stage surgical<br>procedure. The ST<br>Internal Fixture System<br>is intended for use for<br>immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. | The Ti Star Implant<br>System is intended to be<br>placed in the upper or<br>lower jaw to support<br>prosthetic devices, such<br>as artificial teeth, and to<br>restore a patient's<br>chewing function. This<br>may be accomplished<br>using either a two stage<br>surgical procedure or a<br>single stage surgical<br>procedure. The Ti Star<br>Implant System is<br>intended for use for<br>immediate loading when<br>good primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. | The ExFeel Dental<br>Implant Systems are<br>intended to be placed in<br>the upper or lower jaw to<br>support prosthetic<br>devices, such as artificial<br>teeth, and to restore a<br>patient's chewing<br>function. This may be<br>accomplished using<br>either a two stage<br>surgical procedure or a<br>single stage surgical<br>procedure. |

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#### ST Internal Fixture System

#### Implant

| | Proposed device | Predicate device | | |
|-----------------------------------|------------------------------------|-------------------------------------|-------------------------------------|------------|
| Item | ST Internal Fixture system | Ti Star Implant System | ExFeel Dental Implant System | |
| Material | C.P Titanium<br>and Titanium Alloy | C.P Titanium<br>and Titanium Alloy | C.P Titanium<br>and Titanium Alloy | |
| Implant surface<br>treatment | RBM | RBM | RBM | |
| Implant to abutment<br>connection | Internal Hex Connection | Internal Octa Connection | Internal and External<br>Hex | |
| Implant Sterile | Yes | Yes | Yes | |
| Sterilization | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | |
| Implant<br>size (mm) | Diameters | 3.5, 4.0, 4.5, 5.0 | 3.5, 4.1, 4.8 | 3.75 - 5.5 |
| | Lengths | 7.0, 8.5, 10.0, 11.5,<br>13.0, 15.0 | 7.0, 8.5, 10.0, 11.5,<br>13.0, 15.0 | 7.0 - 18.0 |

#### Abutment model

| | Proposed device | Predicate device | |
|------------------|------------------------------------|------------------------------------|------------------------------------|
| Item | ST Internal Fixture<br>system | Ti Star Implant System | ExFeel Dental<br>Implant System |
| Material | C.P Titanium and<br>Titanium Alloy | C.P Titanium and<br>Titanium Alloy | C.P Titanium and<br>Titanium Alloy |
| EZ Post Abutment | | | |
| Diameters (mm) | 4.5, 5.0, 6.0, 7.0 | 5.5 | 4.0, 5.0, 6.0 |
| Cuff | 1.0, 2.0, 3.0, 4.0, 5.0 | 1.5, 2.5, 3.5, 4.5 | - |
| Post H | 4.0, 5.5, 7.0 | 5.5 | - |
| Solid Abutment | | | |
| Diameters (mm) | 4.0, 4.5, 5.0, 6.0, 7.0 | 3.5 | - |
| Cuff H | 1.0, 2.0, 3.0, 4.0, 5.0 | - | - |
| Post H | 4.0, 5.5, 7.0 | 4.0, 5.5, 7.0 | - |

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ST Internal Fixture System

| Angled Abutment | | | |
|------------------|-------------------------|------|-------------------------|
| Diameters (mm) | 4.0, 5.0, 6.0 | - | 4.0, 5.0, 6.0 |
| Cuff | 1.0, 2.0, 3.0, 4.0, 5.0 | - | 2.0, 4.0 |
| Angulation range | $15^\circ$ , $25^\circ$ | - | $15^\circ$ , $25^\circ$ |
| Sterilization | None | None | None |

#### 5.12 Similarity and differences

The differences between the proposed device and the predicate devices are the design of implant to abutment connection and accessory components. The proposed device was tested, and the results complied with the pre-defined success criteria. Therefore, the differences of proposed device and predicate devices did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate devices in intended use, design, safety and performance claims.

### 5.13 Conclusion

After analyzing bench tests, device description and intended use/indications for use, it can be concluded that ST Internal Fixture System is substantially equivalent to the predicate devices.