ST Internal Fixture System by T-PLUS IMPLANT TECH. CO., LTD.

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 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.

AI/ML Overview

The applicant, T-Plus Implant Tech. Co., Ltd., is seeking 510(k) clearance for their ST Internal Fixture System. The device is a dental implant system intended for placement in the upper or lower jaw to support prosthetic devices and restore chewing function, for both two-stage and single-stage surgical procedures. It is also intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The submission aims to demonstrate substantial equivalence to two predicate devices: the Ti Star Implant System (K132992), also from T-Plus Implant Tech. Co., Ltd., and the ExFeel Dental Implant System (K052369) from MegaGen Co., Ltd.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria (Implied)	Reported Device Performance
Sterilization	Device must be sterile.	Leveraged from predicate device (K132992).
Shelf Life	Device must maintain integrity and function over its shelf life.	Leveraged from predicate device (K052369).
Biocompatibility	Device must be biocompatible (non-toxic, non-sensitizing, etc.).	Leveraged from predicate device (K052369). (Cytotoxicity, Intracutaneous Reactivity, Maximization Sensitization, Systemic Injection, Pyrogen, 90-Day Bone Implantation Study)
Fatigue Testing	Device must withstand fatigue according to ISO 14801.	Test results comply with ISO 14801.
RBM Surface Coating Validation	Surface must be free of particles/chemicals from RBM process.	Cleaning validation test and SEM/EDX analysis conducted; results verify removal of particles/chemicals.

2. Sample Size Used for the Test Set and Data Provenance:

The document provides details on non-clinical testing. For the performance tests conducted, such as "Fatigue test" and "RBM surface coating," specific sample sizes are not explicitly stated in the provided text. The data provenance is derived from these non-clinical tests performed on the "proposed device." There is no indication of clinical data, so discussions of country of origin or retrospective/prospective studies are not applicable to the testing mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

This information is not applicable as the provided document details non-clinical laboratory testing, not studies involving human subjects or expert assessment for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable as the provided document details non-clinical laboratory testing, not studies involving human subjects or expert assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No additional clinical testing was necessary for a determination of substantial equivalence."

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the device is a physical medical implant, not an algorithm or software. The "performance testing" described refers to the physical properties of the implant.

7. Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is established by adherence to recognized international standards (e.g., ISO 14801) and scientific methods (e.g., cleaning validation, SEM/EDX analysis). For biocompatibility and sterilization, it is implied that the predicate devices had established ground truth based on their respective testing protocols and regulatory approvals.

8. Sample Size for the Training Set:

This information is not applicable as the document describes a medical device seeking substantial equivalence based on non-clinical testing, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as there is no training set for the described device.

Summary

{0}------------------------------------------------

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

{1}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{2}------------------------------------------------

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 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

{3}------------------------------------------------

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.No.41, Wuquan 6th Rd., Wugu Dist., NewTaipei City 24889, Taiwan (R.O.C)Phone: 886-2-22981950Fax: 886-2-22984353Contact: Dana Cheng (tplus.dana@gmail.com)

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 SystemT-Plus Implant Tech. Co., Ltd.
Device Classification:	II
Review Panel:	Dental
Regulation Number:	872.3640
Primary Product code:	DZE
Subsequent Product code:	NHA

{4}------------------------------------------------

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 for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

5.8 Device Description

{5}------------------------------------------------

Component	Specification (mm)				Angulationrange
	D	L	cuff	Post H
ST Cover Screw	3.15, 3.35,3.7, 3.9	N/A	N/A	0.4, 2.0	N/A
ST Healing screw	4.0, 4.5, 5.0,6.0, 7.0	N/A	N/A	3.0, 4.0, 5.0,6.0, 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, 6.0,7.0	N/A	1.0, 2.0, 3.0,4.0, 5.0	4.0, 5.5, 7.0	N/A
ST Solid Abutment	4.0, 4.5, 5.0,6.0, 7.0	N/A	1.0, 2.0, 3.0,4.0, 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, 3.0,4.0, 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

{6}------------------------------------------------

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.

{7}------------------------------------------------

ST Internal Fixture System

	Proposed device	Predicate device	Predicate device
Item	ST Internal Fixturesystem	Ti Star Implant System	ExFeel DentalImplant System
Manufacturer	T-Plus Implant Tech.Co., Ltd.	T-Plus Implant Tech.Co., Ltd.	MegaGen Co., Ltd.
510(k) Number	K152787	K132992	K052369
Classification	Class II	Class II	Class II
Indication for Use	The ST Internal FixtureSystem is intended to beplaced in the upper orlower jaw to supportprosthetic devices, suchas artificial teeth, and torestore a patient'schewing function. Thismay be accomplishedusing either a two stagesurgical procedure or asingle stage surgicalprocedure. The STInternal Fixture Systemis intended for use forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading.	The Ti Star ImplantSystem is intended to beplaced in the upper orlower jaw to supportprosthetic devices, suchas artificial teeth, and torestore a patient'schewing function. Thismay be accomplishedusing either a two stagesurgical procedure or asingle stage surgicalprocedure. The Ti StarImplant System isintended for use forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading.	The ExFeel DentalImplant Systems areintended to be placed inthe upper or lower jaw tosupport prostheticdevices, such as artificialteeth, and to restore apatient's chewingfunction. This may beaccomplished usingeither a two stagesurgical procedure or asingle stage surgicalprocedure.

{8}------------------------------------------------

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 Titaniumand Titanium Alloy	C.P Titaniumand Titanium Alloy	C.P Titaniumand Titanium Alloy
Implant surfacetreatment	RBM	RBM	RBM
Implant to abutmentconnection	Internal Hex Connection	Internal Octa Connection	Internal and ExternalHex
Implant Sterile	Yes	Yes	Yes
Sterilization	Gamma Irradiation	Gamma Irradiation	Gamma Irradiation
Implantsize (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, 11.5,13.0, 15.0	7.0, 8.5, 10.0, 11.5,13.0, 15.0	7.0 - 18.0

Abutment model

	Proposed device	Predicate device
Item	ST Internal Fixturesystem	Ti Star Implant System	ExFeel DentalImplant System
Material	C.P Titanium andTitanium Alloy	C.P Titanium andTitanium Alloy	C.P Titanium andTitanium 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	-

{9}------------------------------------------------

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.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
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.(b)
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.