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

Device Description

The ST Internal Implant System are made with Grade 4 titanium and surface treatment is done with SLA (Sand-blasted, Large grit, Acid-etched). 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 system are ST internal implant, screw and abutment. The implants in this system are provided in lengths from 7.0-15.0 and in diameters from 3.7-5.1. The 3.7 diameter implant is not provided in the 7.0 length. The ST implants have two types, one is mini and the other is regular. The mini type diameters of ST implants are 3.7 mm and the lengths are 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. The regular type diameters of ST implants are 4.2 mm, 4.6 mm, and 5.1 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. EZ Post abutments, solid abutments, Cylinder abutments, angled abutments, mount screws, cover screws, abutment screws and fixture mounts are included in the system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the "ST Internal Implant System." The approval is based on a determination of substantial equivalence to existing predicate devices, rather than a de novo clinical study with specific acceptance criteria based on human performance.

Therefore, many of the requested details about acceptance criteria, study design with human readers, and ground truth establishment (especially for AI or image analysis devices) are not applicable (N/A) to this 510(k) submission. The performance testing focuses on mechanical and biological properties of the dental implant itself, not on an algorithm's ability to interpret data.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, but does not provide a specific table of quantitative acceptance criteria for all performance parameters and their corresponding reported values in a standardized format. Instead, it states:

Sterilization Test: "leveraged from own K132992 predicate" - implies meeting standards leveraged from prior approval.
Shelf Life Test: "leveraged from own K132992 and K152787 predicate" - implies meeting standards leveraged from prior approval.
Biocompatibility testing:
- Cytotoxicity Test
- Intracutaneous Reactivity Test
- Maximization Sensitization Test
- Systemic Injection Test (Intravenous Injection)
- Pyrogen Test
- "All the test results demonstrate that ST Internal Implant System meets the requirements of its pre-defined acceptance criteria and intended use." (General statement, no specific values given).
90-Day Bone Implantation Study: Listed as performed.
Fatigue test:
- Acceptance Criteria Statement: "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."
- Reported Performance: "Test results comply with ISO14801." (No specific numerical values or pass/fail thresholds are explicitly provided in the document, only a statement of compliance).
SLA surface treatment (cleaning validation and SEM/EDX analysis):
- Acceptance Criteria Statement: "to verify that any particles or chemicals used to remove particles have been washed from the surface."
- Reported Performance: "The SEM/EDX analysis verifies that there were no elements besides titanium found on the surface of the implant."

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

Sample Size for Test Set: Not specified for any of the non-clinical tests (e.g., number of implants tested for fatigue). These are typically lab-based tests, not human data.
Data Provenance: The device manufacturer, T-Plus Implant Tech. Co., Ltd., is located in Taiwan. The tests are "non-clinical testing," implying laboratory or animal studies, not human data from a specific country.
Retrospective or Prospective: N/A for these non-clinical tests.

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

N/A. The testing described is for the physical and biological properties of a dental implant, not for an algorithm where expert radiologist ground truth would be established. The ground truth for mechanical and biocompatibility tests are defined industry standards (e.g., ISO 14801) and established laboratory protocols.

4. Adjudication Method for the Test Set

N/A. Not relevant for non-clinical, lab-based performance tests of a physical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, N/A. This type of study is relevant for diagnostic imaging AI systems and not for a dental implant's mechanical or biological performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

N/A. The device is a dental implant, not an algorithm.

7. The Type of Ground Truth Used

For mechanical testing (e.g., fatigue), the ground truth is compliance with international standards (ISO 14801).
For biocompatibility, the ground truth is compliance with established biological safety requirements (e.g., ISO 10993 series through tests like cytotoxicity, sensitization, implantation, etc.).
For surface analysis, the ground truth is the absence of foreign elements as determined by analytical techniques like SEM/EDX.

8. The Sample Size for the Training Set

N/A. This device does not involve machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set was Established

N/A. As there is no training set for an algorithm, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

February 27, 2020

T-Plus Implant Tech. Co., Ltd. % Yuhua Chen Official Correspondent PuHsu Consulting Ltd. 7F., No.272, Jiankang Rd., Zhonghe Dist. New Taipei County 23553 TAIWAN

Re: K190919

Trade/Device Name: ST Internal Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: January 20, 2020 Received: January 28, 2020

Dear Yuhua Chen:

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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K190919

Device Name ST Internal Implant System

Indications for Use (Describe)

The ST Internal Implant System is intended to be placed in the upper 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 Implant System is intended for use for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

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

Date prepared: February 27, 2020

Submission Submitter 1

Company Name	T-Plus Implant Tech. Co., Ltd.
Address	No.41, Wuquan 6th Rd., Wugu Dist.,
	New Taipei County 24889, Taiwan
Contact	Dana Cheng
Phone	886-2-22981950
Fax	886-2-22984353
Email	danacheng@tplus.com.tw

Submission Correspondent 2

Company Name	PuHsu Consulting Ltd.
Address	7F., No.272, Jiankang Rd., Zhonghe Dist.New Taipei County 23553, Taiwan
Contact	Yuhua Chen
Cell Phone	886-965650265
Email	yuhua@puhsuconsult.com

3 Device Name

Proprietary/Trade Name	ST Internal Implant System
Classification Name	Endosseous dental implant
Device Classification	II
Panel	Dental
Regulation Number	21 CFR 872.3640
Primary Product Code	DZE
Secondary Product Code	NHA

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T-Plus Implant Tech. Co., Ltd. 510(k) K190919

Predicate Device ব

Primary Predicate	K152787, ST Internal Fixture System
Reference Devices	K152786, A Plus Internal Fixture System
	K132992, Ti Star Implant System
	K122231, Xpeed AnyRidge Internal Implant System
	K123988, AnyOneTM Internal Implant System
	K083496, CAMLOG Abutments
	K182313, BoneTrust® Implant System

5 Device Description

The ST implants have two types, one is mini and the other is regular. The mini type diameters of ST implants are 3.7 mm and the lengths are 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. The regular type diameters of ST implants are 4.2 mm, 4.6 mm, and 5.1 mm, and the lengths are 7.0 mm, 8.5 mm, 10.0 mm, 11.5 mm, 13.0 mm, and 15.0 mm. EZ Post abutments, solid abutments, Cylinder abutments, angled abutments, mount screws, cover screws, abutment screws and fixture mounts are included in the system.

Implant
Specification		Description
Minitype	Diameter(mm)	3.7
	Length(mm)	8.5, 10.0, 11.5, 13.0, 15.0
Regular	Diameter(mm)	4.2, 4.6, 5.1

The characteristics of ST Internal Implant and Abutments are provided as below:

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	Implant
typeLength (mm)	7.0, 8.5, 10.0, 11.5, 13.0, 15.0
Design	Threaded, screw type, root-form, fixation, tapered, internal and morse taper, internal hexagonal connection
Material	CP Titanium Gr.4
Surface Treatment	SLA
Sterilization	Sterile. Sterilized by Gamma irradiation.

	Abutments
Item	Specification	Description
EZ Postabutments	Diameter (mm)	4.6, 5.0 (for Mini type)4.6, 5.0, 6.0, 7.0 (for Regular type)
	Cuff Height (mm)	0.8, 1.8, 2.8, 3.8, 4.8
	Lengths (mm)	8.5 – 14.6 (for Mini type)8.5 – 14.5 (for Regular type)
	Design	Hexagonal connection
	Material	CP Titanium Gr.4
	Surface Treatment	Anodized
	Sterilization	Non-sterile. Moist heat sterilization mustbe conducted by the user before use.
Solidabutments	Diameter (mm)	4.0, 4.6 (for Mini type)4.0, 4.6, 5.0, 6.0, 7.0 (for Regular type)
	Cuff Height (mm)	0.8, 1.8, 2.8, 3.8, 4.8
	Lengths (mm)	10 – 17.0 (for Mini type)10.4 – 15.9 (for Regular type)
	Design	Circular connection
	Material	Titanium Gr.5
	Surface Treatment	Anodized
	Sterilization	Non-sterile. Moist heat sterilization mustbe conducted by the user before use.
Cylinderabutments	Diameter (mm)	4.0, 5.0 (for Mini type)4.0, 5.0, 6.0 (for Regular type)
	Lengths (mm)	10.6 – 14.6 (for Mini type)10.5 - 14.5 (for Regular type)
	Design	Hexagonal connection

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		Abutments
Item	Specification	Description
	Surface Treatment	Anodized
	Sterilization	Non-sterile. Moist heat sterilization mustbe conducted by the user before use.
	Angulation range	0°
Angledabutments	Diameter (mm)	4.6, 5.0, 6.0
	Cuff Height (mm)	1.0, 2.0, 3.0, 4.0
	Angulation range	15°, 25°
	Design	Hexagonal connection
	Material	CP Titanium Gr.4
	Surface Treatment	Anodized
	Sterilization	Non-sterile. Moist heat sterilization mustbe conducted by the user before use.

6 Indications for Use

7 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 Implant System meets the requirements of its pre-defined acceptance criteria and intended use.

. Sterilization Test (leveraged from own K132992 predicate)
Shelf Life Test (leveraged from own K132992 and K152787 predicate) .
Biocompatibility testing
- Cytotoxicity Test ●
- Intracutaneous Reactivity Test
- Maximization Sensitization Test
- Systemic Injection Test (Intravenous Injection)
- Pyrogen Test

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90-Day Bone Implantation Study ●
Performance testing
- Fatique 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.

SLA surface treatment
ST Internal Implant System undergoes an implant surface treatment of Sand-blasted, Large grit, Acid-etched (SLA) which differs from the predicate devices. The cleaning validation tests 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. The SEM/EDX analysis verifies that there were no elements besides titanium found on the surface of the implant.

8 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.

9 Substantial Equivalence Determination

The ST Internal Implant System submitted in this 510(k) file is substantially equivalent in the design of implant to abutment connection, main materials, angulation range, safety and performance claims to the cleared ST Internal Fixture System (K152787), A Plus Internal Fixture System (K152786), Ti Star lmplant System (K132992), Xpeed AnyRidge Internal Implant System (K122231), AnyOne™ Internal Implant System (K123988), CAMLOG Abutments (K083496), and BoneTrust® Implant System (K182313). Differences between the proposed device system and the predicate device have been resolved through biocompatibility and performance testing which shows substantial equivalence of the subject device.

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9.1 Implant, Cylinder Abutment, Angled Abutment

		Proposed device	Primary Predicate -1T-Plus Implant Tech. Co.,Ltd.	Reference Device -2T-Plus Implant Tech. Co.,Ltd.	Reference Device -3T-Plus Implant Tech. Co.,Ltd.	Reference Device -4MegaGen Implant Co., Ltd.	Reference Device -5MegaGen Implant Co., Ltd.
Feature		ST Internal Implant System	ST Internal Fixture System(K152787)	A Plus Internal FixtureSystem(K152786)	Ti Star Implant System(K132992)	AnyOne™ Internal ImplantSystem(K123988)	Xpeed AnyRidge InternalImplant System(K122231)	Comments
Indication for Use		The ST Internal Implant Systemis intended to be placed in theupper or lower jaw to supportprosthetic devices, such asartificial teeth, and to restore apatient's chewing function. Thismay be accomplished usingeither a two stage surgicalprocedure or a single stagesurgical procedure. The STInternal Implant System isintended for use for immediateloading when good primarystability is achieved and withappropriate occlusal loading.	The ST Internal FixtureSystem is intended to beplaced in the upper or lowerjaw to support prostheticdevices, such as artificialteeth, and to restore apatient's chewing function.This may be accomplishedusing either a two stagesurgical procedure or asingle stage surgicalprocedure. The ST InternalFixture System is intendedfor use for immediateloading when good primarystability is achieved andwith appropriate occlusalloading.	The A Plus Internal FixtureSystem is intended to beplaced in the upper or lowerjaw to support prostheticdevices, such as artificialteeth, and to restore apatient's chewing function.This may be accomplishedusing either a two stagesurgical procedure or asingle stage surgicalprocedure. It is intended fordelayed loading.	The Ti Star Implant System isintended to be placed in theupper or lower jaw to supportprosthetic devices, such asartificial teeth, and to restorea patient's chewing function.This may be accomplishedusing either a two stagesurgical procedure or asingle stage surgicalprocedure. The Ti StarImplant System is intendedfor use for immediate loadingwhen good primary stabilityis achieved and withappropriate occlusal loading.	The AnyOne™ InternalImplant System is intendedto be surgically places inthe maxillary or mandibularmolar areas for the purposeproviding prosthetic supportfor dental restoration(Crown, bridges, andoverdentures) in partially orfully edentulous individuals.It is used to restore apatient's chewing function.Smaller implant (less thanØ6.0mm) are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for the molarregion and are indicated fordelayed loading.	The Xpeed AnyRidgeInternal Implant System isintended to be surgicallyplaces in the maxillary ormandibular molar areas forthe purpose providingprosthetic support fordental restoration (Crown,bridges, and overdentures)in partially or fullyedentulous individuals. It isused to restore a patient'schewing function. Smallerimplant (less than Ø6.0mm)are dedicated forimmediate loading whengood primary stability isachieved and withappropriate occlusalloading. Larger implantsare dedicated for the molarregion and are indicated fordelayed loading.	Identical to predicatedevice 1, 2, 3
Material		C.P Titanium	C.P Titanium	C.P Titanium and TitaniumAlloy	C.P Titanium and TitaniumAlloy	CP4 Titanium andTi-6Al-4V-ELI	CP Titanium, Gr.4 andTi-6Al-4V-ELI	Identical to predicatedevice 1
	Implant surface treatment	SLA	RBM	RBM	RBM	SLA	SLA	Equivalent topredicate device 4, 5
Implant to abutmentconnection		Internal Hex Connection	Internal Hex Connection	Internal Hex Connection	Internal Hex Connection	Internal Hex	Internal Hex	ldentical
Implant Sterile		Yes	Yes	Yes	Yes	Yes	Yes	ldentical
Sterilization		Gamma	Gamma	Gamma	Gamma	Gamma	Gamma	ldentical
	Implantsize	Diameter(mm) andLength (mm)	Ø 3.7 mm: 8.5, 10.0, 11.5, 13.0,15.0 mm	Ø 3.5 mm: 8.5, 10.0, 11.5,13.0, 15.0 mmØ 4.0 mm: 7.0, 8.5, 10.0,11.5, 13.0, 15.0 mmØ 4.5 mm: 7.0, 8.5, 10.0,11.5, 13.0, 15.0 mm	Ø 3.4 mm: 8.0, 10.0, 12.0,14.0 mmØ 3.8 mm: 8.0, 10.0, 12.0,14.0 mm	Ø 3.5 mm: 7.0, 8.5, 10.0,11.5, 13.0, 15.0 mm	Normal ThreadØ 3.9 mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mmØ 4.3mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mm	Normal RidgeØ 4.0 mm: 7.7, 9.2, 10.7,12.2, 14.2, 17.2 mm	Diameters and lengths are
			Ø 4.2 mm: 7.0, 8.5, 10.0, 11.5,13.0, 15.0 mm		Ø 4.3 mm: 8.0, 10.0, 12.0,14.0 mm	Ø 4.1 mm: 7.0, 8.5, 10.0,11.5, 13.0, 15.0 mm	Ø 4.8 mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mm	Ø 4.4 mm: 7.7, 9.2, 10.7,12.2, 14.2, 17.2 mm	within the range ofpredicate device 1 and 2.
			Ø 4.6 mm: 7.0, 8.5, 10.0, 11.5,13.0, 15.0 mm		Ø 4.8 mm: 8.0, 10.0, 12.0,14.0 mm	Ø 4.8 mm: 7.0, 8.5, 10.0,11.5, 13.0, 15.0 mm	Ø 5.3 mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mm	Ø 4.9 mm: 7.7, 9.2, 10.7,12.2, 14.2, 17.2 mm	However, the Ø5.1x7.0mm is within rangeof predicate device 4 and
			Ø 5.1 mm: 7.0, 8.5, 10.0, 11.5,13.0, 15.0 mm	Ø 5.0 mm: 7.0, 8.5, 10.0,11.5, 13.0, 15.0 mm	Ø 5.3 mm: 8.0, 10.0, 12.0,14.0 mm		Ø 6.3 mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mm	Ø 5.4 mm: 7.7, 9.2, 10.7,12.2, 14.2, 17.2 mm	the Ø 5.1x15.0mm iswithin range of predicatedevice 5.
								Ø 5.9 mm: 7.7, 9.2, 10.7,12.2, 14.2, 17.2 mm
Feature		Proposed device	Primary Predicate -1T-Plus Implant Tech. Co.,Ltd.	Reference Device -2T-Plus Implant Tech. Co.,Ltd.	Reference Device -3T-Plus Implant Tech. Co.,Ltd.	Reference Device -4MegaGen Implant Co., Ltd.	Reference Device -5MegaGen Implant Co., Ltd.
		ST Internal Implant System	ST Internal Fixture System(K152787)	A Plus Internal FixtureSystem(K152786)	Ti Star Implant System(K132992)	AnyOne™ Internal ImplantSystem(K123988)	Xpeed AnyRidge InternalImplant System(K122231)	Comments
						Ø 7.3 mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mmDeep Thread
						Ø 4.8 mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mm
						Ø 5.8 mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mm
						Ø 6.8 mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mm
						Ø 7.8 mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mm
						Ø 8.3 mm: 7.0, 8.5, 9.5,11.0, 12.5, 14.5 mm
CylinderAbutment	Diameter(mm)	4.0, 5.0, 6.0	-	-	-	3.8 – 10.0	-	Diameters are withinrange of predicate device4
size	Length (mm)	10.5 – 14.6	-	-	-	7.7 - 18.7	-	Length are within range ofpredicate device 4
AngledAbutmentsize	Diameter(mm)	4.6, 5.0, 6.0	4.0, 5.0, 6.0	4.0, 5.0, 6.0	-	3.8 – 10.0	-	Diameters are withinrange of predicate device1
	Cuff Height(mm)	1.0, 2.0, 3.0, 4.0	1.0, 2.0, 3.0, 4.0, 5.0	2.0, 3.0, 4.0, 5.0	-	-	-	Cuff heights are withinrange of predicate device1
	Angulationrange	15°, 25°	15°, 25°	15°, 25°	-	15°, 25°	-	Identical to predicatedevice 1, 2, 4

ST Internal Implant System

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

9.2 EZ Post Abutment

Feature	Proposed deviceST Internal Implant System	Primary Predicate -1T-Plus Implant Tech. Co., Ltd.ST Internal Fixture System(K152787)	Reference Device -2Altatec GmbHCAMLOG Abutments(K083496)	Reference Device -3Medical Instinct Deutschland GmbHBoneTrust® Implant System(K182313)
Material	CP Titanium Gr.4	CP Titanium Gr.4	Titanium alloy TiAl4V	Titanium alloy TiAl4V	Identic
Surface	Anodized surface	Anodized surface	Anodized surface	Anodized surface	Identic
Diameter (mm)	4.6, 5.0 (for Mini type)4.6, 5.0, 6.0, 7.0 (for Regular type)	4.0, 5.0, 6.0, 7.0	3.8, 4.3, 5.0, 6.0	3.4, 4.0, 5.0	Diameter
Cuff Height (mm)	0.8, 1.8, 2.8, 3.8, 4.8	1.0, 2.0, 3.0, 4.0, 5.0	0.8, 1.5	0.5, 0.7, 2.5, 4.5	The m
Connection	Hexagonal connection	Hexagonal connection	Conical fitting	Cylindrical external Hexagonor and conical torx	Identic
Angulation range	0°	0°	0°, 15°, 20°	0°, 15°, 20°	Identic

Comments

cal to predicate device 1

cal

eters are within range of predicate

e 1
minimum length is identical to
cate device 2 and bigger than device
cate device 2 and bigger than device
predicate device 1.

cal to predicate device 1

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

9.3 Solid Abutment

Feature	Proposed device	Primary Predicate -1T-Plus Implant Tech. Co., Ltd.	Reference Device -2Altatec GmbH	Reference Device -3Medical Instinct Deutschland GmbH
	ST Internal Implant System	ST Internal Fixture System(K152787)	CAMLOG Abutments(K083496)	BoneTrust® Implant System(K182313)
Material	Titanium Gr.5	Titanium Gr.5	Titanium alloy TiAl4V	Titanium alloy TiAl4V
Surface	Anodized surface	Anodized surface	Anodized surface	Anodized surface
Diameter (mm)	4.0, 4.6 (for Mini type)4.0, 4.6, 5.0, 6.0, 7.0 (for Regulartype)	4.0, 4.5, 5.0, 6.0, 7.0	3.8, 4.3, 5.0, 6.0	3.4, 4.0, 5.0
Cuff Height (mm)	0.8, 1.8, 2.8, 3.8, 4.8	1.0, 2.0, 3.0, 4.0, 5.0	0.8, 1.5	3.0
Connection	Circular connection	Circular connection	Conical fitting	Cylindrical external Hexagonor and conical torx
Angulation range	0°	0°	0°, 15°, 20°	0°

Comments

ical to predicate device 1 ical

leters are within range of predicate
ce 1

minimum length is identical to
cate device 2, and the maximum
h is smaller than predicate device 1.

ical to predicate device 1

ical to predicate device 1 and 3

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

10 Similarity and differences

The differences between the proposed device and the predicate devices are accessory components, and implant surface treatment. 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.

11 Conclusion

After analyzing bench tests, device description and intended use/indications for use, it can be concluded that ST Internal Implant 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.