This Product is to be used in mandible or maxilla-arch by dental surgery, and to support artificial teeth and maxilla to restore patient's chewing function.

This may be accomplished by either a two-stage surgical procedure or a single surgical procedure. If a single surgical procedure is used, single or multiple implants may be inserted (type I, II or III bone) provided good initial stability (> 40 Ncm) is achieved. Intended for delayed loading.

Device Description

(1) This Product is designed to be used in dental surgery in mandible or maxilla-arch, where has missing teeth, to have dental crown, fixation-bridge, over-denture installed afterwards, and to support and restore patient's chewing function.
(2) This implant (Ti-one 101 TS dental implants (Fixture)) is made of grade 4 pure titanium, featuring sandblasting + acid etching surface treatment (SLAffinity).
(3) Healing screw is one-piece abutment made of grade 4 titanium.
(4) Abutment is two-piece abutment made of grade 4 titanium. Its surface was anodized.
(5) Label attached to the surface of outer packaging indicates specification and model number.

The range of diameter for implant (fixture) is provided as below:
Ø Diameter: 3.5, 4.0, 4.5, 5.0 mm
Length: 7.0, 8.0, 9.5, 11.0, 12.5, 14.0 mm

All diameters are available in all lengths, other than the 3.5mm diameter which is not available in the 7.0mm length.

The range of diameters and angulations for each screw model and abutment model are provided as below:
Healing Screw: Ø 4.3 mm, G/H 1.0, 3.0, 4.0 mm, Height (H) 3.5, 5.0, 7.0 mm
Angled Abutment: Ø 4.5, 5.5 mm, G/H 3.5 mm, V/H 11.0 mm, Length (L) 14.13, 14.15, 14.20 mm, Angulation range 12.5°, 20.0°, 27.5°

AI/ML Overview

The provided document is a 510(k) summary for the "Ti-one 101 TS Dental Implant System." It does not describe an AI or software as a medical device (SaMD). Instead, it details a traditional medical device (dental implant system) and its non-clinical testing for substantial equivalence to predicate devices. Therefore, many of the requested categories related to AI/SaMD studies are not applicable.

Here's an analysis of the provided information, focusing on what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria (General)	Reported Device Performance
Sterilization	Compliance with ISO11737-1:2006, ISO11737-2:2009, ISO 11137-2:2013	Proposed device complies with all listed ISO standards.
Shelf Life	Compliance with ASTM F1980:2016, ASTM F1929:2012, ISO 11607-1:2006, ASTM F-88 / F88M:2015, ISO 11737-2:2009	Proposed device complies with all listed ASTM and ISO standards.
Biocompatibility	Compliance with ISO 10993 series (various parts), USP, and OECD guidelines for predicate device; USP and AAMI for non-pyrogenic test.	Predicate Device (K110425): Complies with all listed ISO, USP, and OECD requirements for cytotoxicity, intracutaneous reactivity, skin sensitization, acute systemic toxicity, pyrogenicity, in vitro mutation/aberration tests, and 14-day/90-day toxicity tests.
		Proposed Device (Non-pyrogenic): Complies with USP 40:2017 <85>, USP 40:2017 <161>, AAMI ST72:2011.
Performance Testing	Compliance with ISO 14801:2007 and ASTM F543-13:2013	Reported as meeting "pre-defined acceptance criteria." (Specific details of torque, fatigue, or SEM/EDS results are not provided beyond this statement).

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not specified in the document. The document refers to "test reports" for each test category but does not include the number of units tested.
Data Provenance: The biocompatibility tests for the predicate device (K110425) are leveraged from the same manufacturer, Hung Chun Bio-S Co., Ltd. The document does not specify the country of origin of the data or whether the tests were retrospective or prospective, though performance and biocompatibility testing of medical devices are typically prospective bench or in-vitro tests conducted in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device is a physical dental implant, not an AI or SaMD requiring expert interpretation for ground truth establishment. Its performance is evaluated through standardized mechanical, biological, and sterilization tests.

4. Adjudication method for the test set

Not Applicable. As above, the device is evaluated through objective, standardized tests, not through expert adjudication of data.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This study is for a physical medical device (dental implant system), not an AI or SaMD. No human readers or AI assistance are involved in its evaluation as described.

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

Not Applicable. This is not an algorithm or SaMD.

7. The type of ground truth used

For the non-clinical tests (sterilization, shelf life, biocompatibility, performance), the "ground truth" is defined by the specific requirements and passing criteria of the referenced international/national standards (e.g., ISO, ASTM, USP, AAMI, OECD guidelines). The device's performance is measured against these objective criteria.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/SaMD. There is no concept of a "training set" in the context of this 510(k) summary.

9. How the ground truth for the training set was established

Not Applicable. As above, there is no training set for this device.

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and white and includes the words "U.S. Food & Drug Administration."

Hung Chun Bio-S Company, Limited Allison Liu Quality Assurance Supervisor No.12, Luke 1st Road, Luzhu District Kaohsiung City, 821 TAIWAN (R.O.C.)

Re: K172821

Trade/Device Name: Ti-one 101 TS Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: May 4, 2018 Received: May 11, 2018

Dear Allison Liu:

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.

June 11, 2018

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K172821

Device Name

Ti-one 101 TS Dental Implant System

This Product is to be used in mandible or maxilla-arch by dental surgery, and to support artificial teeth and maxilla to restore patient's chewing function.

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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Ti-one 101 TS Dental Implant System 510(k) Summary

510(k) Summary

5.1	Type of Submission:	Traditional
5.2	Preparation Date:	06/11/2018
5.3	Submitter:	Hung Chun Bio-S Co., Ltd.
	Address:	No.12, Luke 1st Rd., Luzhu Dist.,Kaohsiung City, 821, Taiwan (R.O.C.)
	Phone:	+886-7-6955369
	Fax:	+886-7-6955379
	Contact:	Allison Liu (allison@hc-bios.com)

5.4 Identification of the Device:

Proprietary/Trade name:	Ti-one 101 TS Dental Implant System
Classification Name:	Endosseous dental implant
Device Classification:	II
Panel:	Dental
Regulation Number:	872.3640
Primary Product Code:	DZE
Subsequent Product Code:	NHA

5.5 Primary Predicate Device (K110425):

Proprietary/Trade name:	HC-Bios Dental Implant System
Manufacturer:	Hung Chun Bio-S Co., Ltd.
Device Classification:	II
Review Panel:	Dental
Regulation Number:	872.3640
Product Code:	DZE

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Ti-one 101 TS Dental Implant System 510(k) Summary

5.6	Reference Device (K120414):
	Proprietary/Trade name:	OsseoSpeedTM Plus
	Manufacturer:	Astra Tech AB
	Device Classification:	II
	Review Panel:	Dental
	Regulation Number:	872.3640
	Product Code:	DZE, NHA
5.7	Reference Device (K051636):
	Proprietary/Trade name:	CAMLOG Dental Implant AbutmentHealingCaps, and Accessories
	Manufacturer:	Altatec GmbH
	Device Classification:	II
	Review Panel:	Dental
	Regulation Number:	872.3630
	Product Code:	NHA

5.8 Indications for use of the subject device

This Product is to be used in mandible or maxilla-arch by dental surgery, and to support artificial teeth and maxilla to restore patient's chewing function.

5.9 Device Description

(1) This Product is designed to be used in dental surgery in mandible or maxilla-arch, where has missing teeth, to have dental crown, fixation-bridge, over-denture installed afterwards, and to support and restore patient's chewing function.
(2) This implant (Ti-one 101 TS dental implants (Fixture)) is made of grade 4 pure titanium, featuring sandblasting + acid etching surface treatment (SLAffinity).
(3) Healing screw is one-piece abutment made of grade 4 titanium.
(4) Abutment is two-piece abutment made of grade 4 titanium. Its surface was

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

anodized.

(5) Label attached to the surface of outer packaging indicates specification and model number.
The range of diameter for implant (fixture) is provided as below:

Component	Specification (mm)
	Ø Diameter	Length
Implant (Fixture)	3.5, 4.0, 4.5, 5.0	7.0, 8.0, 9.5, 11.0, 12.5, 14.0

All diameters are available in all lengths, other than the 3.5mm diameter which is not available in the 7.0mm length.

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

Component	Specification (mm)			Angulationrange
	Ø	G/H	V/H	Height (H) orLength (L)
HealingScrew	4.3	1.0, 3.0, 4.0	-	H: 3.5, 5.0, 7.0	-
AngledAbutment	4.5, 5.5	3.5	11.0	L: 14.13, 14.15,14.20	12.5°, 20.0°,27.5°

5.10 Non-clinical Testing

A series tests were performed to assess the proposed device is substantially equivalent to the predicate device. All the test results demonstrate that Ti-one 101 TS Dental Implant System meets the requirements of its pre-defined acceptance criteria and indications for use.

· Sterilization Test

Test results performed in test reports of sterilization test demonstrated that proposed device complies with ISO11737-1:2006, ISO11737-2:2009 and ISO 11137-2:2013 requirements.

· Shelf Life Test

Test results performed in test reports of shelf life test demonstrated that proposed device complies with ASTM F1980:2016, ASTM F1929:2012, ISO 11607-1:2006, ASTM F-88 / F88M:2015 and ISO 11737-2:2009 requirements.

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Ti-one 101 TS Dental Implant System 510(k) Summary

• Biocompatibility testing

Non-pyrogenic test report (LAL testing)

(Following reports are leveraged from own K110425 predicate)

Cytotoxicity test i
Intracutaneous reactivity test ।
Skin sensitization test -
Acute systemic toxicity test (Systemic injection)
। Pyrogenicity test
In vitro bacterial reverse mutation (AMES) test ।
In vitro chromosome aberration test i
In vitro mammalian cell gene mutation test -
14-Day Repeated exposure systemic toxicity test
। 90-Day Bone implantation test

Both proposed device and predicate device, "HC Bio-S" Dental implant system (K110425) are manufactured by Hung Chun Bio-S Co., Ltd. The materials of proposed device and predicate device (K110425) are exactly the same. Therefore, the information of biocompatibility testing for predicate device (K110425) is sufficient to describe the safety of the proposed device and demonstrate the substantial equivalence of the proposed device to the predicate device. Test results performed in biocompatibility test reports demonstrated that predicate device (K110425) complies with ISO 10993-1, ISO 10993-3:2003, ISO 10993-5:2009, ISO10993-6:2007, ISO 10993-10:2010, ISO10993-11:2006, ISO 10993-12:2012, USP 31:2008 <87> , US P31:2008 <151>, OECD 471:1997, OECD 473:1997 and OECD476:1997 requirements. Test results performed in "Non-pyrogenic test report (LAL testing)" demonstrated that proposed device complies with USP 40:2017 <85>, USP 40:2017 <161>, AAMI ST72:2011 requirements.

• Performance testing:

Insertion, Removal Torque and Broken Test
Fatigue test -
SEM/EDS surface structure chart report ।

Tests were conducted in accordance with ISO 14801:2007 and ASTM F543-13:2013 requirements.

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5.11 Clinical Testing

No 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 device.

5.12 Substantial Equivalence Determination

The Ti-one 101 TS Dental Implant System submitted in this 510(k) file is substantially equivalent in main materials, implant surface treatment and similar design, angulation range, indication for use, components and performance claims to the cleared HC-Bios Dental Implant System (K110425), CAMLOG Dental Implant Abutments, HealingCaps, and Accessories (K051636) and OsseoSpeed TM Plus (K120414). Differences of proposed device and predicate device do not raise new issues of substantial equivalence.

	Proposed Device	Primary Predicate Device(K110425)	Substantiallyequivalent
Item	Ti-one 101 TS DentalImplant System	HC-Bios Dental ImplantSystem	-
Manufacturer	Hung Chun Rio-S Co., Ltd.	Hung Chun Rio-S Co., Ltd.	Same
510(k) Number	K172821	K110425	-
Classification	Class II	Class II	Same
Product code	DZE, NHA	DZE	SimilarThe primaryproduct code isthe same.
Indication for Use	The product is to be used inmandible or maxilla-arch bydental surgery, and to supportartificial teeth and maxilla torestore patient's chewingfunction.This may be accomplished by	The HC-Bios Dental ImplantSystem is intended to besurgically placed in the bone ofthe upper or lower jaw arches toprovide support for prostheticdevices, such as artificial teeth,and to restore the patient's	Similar1

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Ti-one 101 TS Dental Implant System 510(k) Summary

	Proposed Device	Primary Predicate Device(K110425)	Substantiallyequivalent
Item	Ti-one 101 TS DentalImplant System	HC-Bios Dental ImplantSystem	-
	either a two-stage surgicalprocedure or a single surgicalprocedure. If a single surgicalprocedure is used, single ormultiple implants may beinserted (type I, II or III bone)provided good initial stability (>40 Ncm) is achieved`. Intendedfor delayed loading.	chewing function.This may be accomplished byeither a two-stage surgicalprocedure or a single surgicalprocedure. If a single surgicalprocedure is used, single ormultiple implants may beinserted (type I, II or III bone)provided good initial stability (>40 Ncm) is achieved. Notintended for immediate loading.
Components	Dental implant (Fixture)	Dental implantCover/Healing screwStandard abutmentAbutment impression partImplant impression part	Only comparethe implant(fixture) and theproposedimplant is SE tothe implant ofpredicate.
	Healing screw
	Angled abutment
Surgery type	It may be accomplished bytwo-stage procedure	It may be accomplished bytwo-stage procedure	Same

� Similar1 :

Both proposed device and primary predicate device are used in mandible or maxilla-arch by dental surgery, and to support artificial teeth and maxilla to restore patient's chewing function. Both devices could be used for two-stage surgery procedure. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.

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Ti-one 101 TS Dental Implant System 510(k) Summary

Implant

	Proposed Device	Primary Predicate Device(K110425)	Substantiallyequivalent
Item	Ti-one 101 TS Dental ImplantSystem	HC-Bios Dental ImplantSystem	-
Material	Grade 4 Pure Titanium	Grade 4 Pure Titanium	Same
Surface treatment	SLA	SLA	Same
Implant to abutmentconnection	Internal 11° morse taper	Internal 11° morse taper	Same
Design	Thread with micro thread	Thread	Similar
Diameters	3.5, 4.0, 4.5, 5.0 mm	3.5, 4.0, 4.5, 5.0, 6.0, 7.0 mm	Similar
Lengths	7.0, 8.0, 9.5, 11.0,12.5, 14.0 mm	7.0, 8.0, 9.5, 11.0,12.5, 14.0 mm	Similar
Sterile	Yes, Gamma irradiation	Yes, Gamma irradiation	Same

The design is similar, and the diameter of the proposed device is within the scope of that of predicate. The Ø3.5mm implant is not available in the 7.0mm length for either the subject or primary predicate. The primary predicate is also not available in the Ø4.0mm/7.0mm length, which is an option for the subject device. Additionally, the primary predicate is available in all other combinations of diameter and length, except for Ø6.0mm and Ø7.0mm which are both not available in the 14mm length. Differences between the devices cited in this section do not raise any new issues of substantial equivalence.

Healing screw

や

	Proposed Device	Primary PredicateDevice (K110425)	Reference Device(K051636)	Substantiallyequivalent
Item	Ti-one 101 TSDental ImplantSystem	HC-Bios DentalImplant System	CAMLOG DentalImplant Abutments,HealingCaps, andAccessories	-
Diameters	4.3 mm	4.5, 5.5, 6.5 mm	3.3, 3.8, 4.3,5.0, 6.0 mm	Similar
G/H	1.0, 3.0, 4.0 mm	2.0, 3.0, 4.0 mm	2.0, 4.0, 6.0 mm	Similar
Height	3.5, 5.0, 7.0 mm	3.5, 5.0, 7.0 mm	4.0, 6.0 mm	Similar

ゃ Although the proposed healing screw has a smaller diameter than the primary predicate, it is same as FDA-cleared reference device. Therefore, differences between the devices cited in this

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

Ti-one 101 TS Dental Implant System 510(k) Summary

section do not raise any new issues of substantial equivalence.

	Proposed Device	Reference Device (K120414)	Substantiallyequivalent
Item	Ti-one 101 TS Dental ImplantSystem	OsseoSpeedTM Plus	-
Material	Grade 4 Pure Titanium	Titanium	Similar
Surface treatment	Anodization	None	Different
Abutment size	Angled abutment	Angled abutment (TiDesign)	SomeDifferences
Diameters	4.5, 5.5 mm	4.0, 4.5, 5.5 mm
G/H (mm)	3.5	1.5
V/H (mm)	11.0	for Ø4.0, 7; for Ø4.5 and Ø5.5, 9
Angulation range	12.5°, 20.0°,27.5°	15° for Ø4.0mm,20° for Ø4.5 and Ø5.5
Sterile	Yes, Gamma irradiation	Yes	Similar

Angled abutment

Although the proposed Angled abutment has a smaller G/H, larger anglulation, and ゃ different surface coating than the reference device, according to the testing result of fatigue report, differences between the devices cited in this section do not raise any new issues of substantial equivalence.

5.13 Similarity and differences

The difference between the implant of the proposed device and the predicate device is the design. The surface designed of proposed device and predicate device are thread with micro thread or thread only respectively. The Healing screw and Angled abutment were compared with the appropriate FDA-cleared reference devices to demonstrate substantial equivalence. The proposed device was tested, and the results complied with the pre-defined acceptance criteria. Therefore, the differences of proposed device and predicate device did not raise any problems of substantial equivalence. The proposed device is substantially equivalent to the predicate device in indications for use, design and performance claims.

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5.14 Conclusion

After analyzing bench tests, device description and indications for use, it can be concluded that Ti-one 101 TS Dental Implant System is substantially equivalent to the predicate device.

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.