The JTK one-piece integrated dental implant system is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

JTK Two-Piece Implant System:

The JTK two-piece dental implant system is comprised of dental implant fixtures and prosthetic devices a two-piece implant system. The implants are intended for use in the mandla, in support of single unit or multiple unit cement or screw-receiving restorations and support of overdentures. The implants are intended for immediate placement and function for the support of single tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

Device Description

The JTK Dental Implant System is offered in two different models consist of a one-piece integrated implant system where the implant and abutment are machined from the same piece of titanium, and a traditional two-piece implant system that consists of an implant and abutment that are made from different pieces titanium and held together by way of a supplied titanium healing cap is also supplied with the two-piece implants and abutments are supplied individually packaged and sterile to the end user via gamma radiation. The healing cap is packaged with the implant and the attachment screw is packaged with the abutment. All implant System are made by traditional CNC manufacturing methods. For both models of the implant body, the threaded portion receives a surface modification using sandblasting and acid etching (SLA).

For the one-piece implant system, the implants are offered in two thread diameters (3.0 and 3.3 mm) and in three thread lengths (10, 13 and 15 mm). The integral abutment portion of the implant is contoured and machined, is without a surface modification, and is offered in two platform heights (4 and 6 mm).

For the two-piece implant system, the implants are offered in five thread diameters (3.8, 4.0, 4.5, 5.0 and 5.5 mm) and in four thread lengths (8, 10, 13 and 15 mm). The neck of the implant is conical in shape, 2.5 mm in height and has been machined and is without a surface modification. The two-piece implant bodies are considered a tissue level implant. The abutments that are used with the two-piece system are offered in two different models (straight and angled (15° and 25°). The straight abutments are offered in a diameter of 4.4 mm and in lengths of 4.2, 5.2, 6.2 and 8.2 mm. The 15° angled abutments are offered in a diameter of 4.4 mm and in lengths of 6.0 and 8.0 mm, while the 25° the angled abutments are offered in a diameter of 4.4 mm and in lengths of 6.0 and 10.5 mm.

The titanium used to manufacture the one-piece implants conform with ASTM F67, Standard Specification for Unalloyed Titanium, for Surgical Implant Applications while the titanium used to manufacture the abutments conform with ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

AI/ML Overview

The provided text is an FDA 510(k) Premarket Notification summary for the JTK Dental Implant System. It focuses on demonstrating substantial equivalence to predicate devices through comparisons of device characteristics and non-clinical performance data.

Crucially, this document describes a dental implant system, a physical medical device, not a software or AI/ML-based device. Therefore, the concepts of acceptance criteria for algorithm performance (like sensitivity, specificity, AUC), ground truth experts, adjudication methods, MRMC studies, or training/test sets in the context of an AI/ML algorithm are not applicable to this submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical performance testing required for medical devices to demonstrate safety and effectiveness and substantial equivalence to existing predicate devices.

Here's an interpretation based on the provided text, aligning with the type of device being discussed:

1. A table of acceptance criteria and the reported device performance:

The "acceptance criteria" here are generally international standards and FDA guidance documents that the device must conform to for safety and performance. The "reported device performance" indicates whether the device passed these tests.

Acceptance Criterion (Standard/Guidance)	Reported Device Performance
Biocompatibility Testing per ISO 10993-1 (cytotoxicity, rabbit pyrogen test)	Passed all testing
Dynamic Fatigue Testing per ISO 14801	Demonstrated 5x10^6 cycles without failure
Sterilization Validation per ISO 11137-1, -2, -3	Demonstrated a SAL of 10^-6 via gamma radiation
Shelf-life Validation per ASTM F1980-07	Stated shelf-life of 2 years
Packaging Validation per ISO 11607	Stated (implicit in shelf-life validation)
Risk Analysis per ISO 14971	Conforms to the ISO standard
LAL testing for pyrogenicity (FDA Guidance)	Addressed all recommendations

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

For this type of physical device, "sample size" refers to the number of physical units tested. The document does not specify exact numbers for each test (e.g., how many implants were tested for fatigue). The provenance is "Jiangyin Jintech Biotech Co., Ltd." in "Jiangyin City, Jiangsu Province, China," as they conducted the performance testing. These are non-clinical (laboratory) studies.

Sample Size: Not explicitly stated for each test (e.g., number of implants for fatigue testing), but implied to be sufficient to meet the requirements of the standards.
Data Provenance: Non-clinical (laboratory) testing conducted by Jiangyin Jintech Biotech Co., Ltd. in China.
Retrospective or Prospective: These are laboratory tests specifically conducted for the submission, so they are prospective in nature to generate data to support the 510(k).

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

This concept is not applicable here. Ground truth is typically established for diagnostic or AI/ML performance. For a dental implant, "ground truth" relates to its physical and biological performance as measured by objective tests (e.g., fatigue strength, biocompatibility, sterilization efficacy) against established international standards. The "experts" are the engineers, scientists, and technicians who design, conduct, and analyze these standardized tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This concept is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (e.g., radiologists interpreting images) to resolve disagreement. For physical device performance testing, the results are typically quantitative measurements against objective criteria, not subjective interpretations requiring adjudication.

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:

This concept is not applicable. An MRMC study is relevant for AI/ML-assisted diagnostic devices. This submission concerns a physical dental implant. There are no "human readers" or "AI assistance" in the context of this device.

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

This concept is not applicable as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this medical device is the adherence to established international consensus standards (e.g., ISO, ASTM) and FDA guidance for the physical, chemical, and biological properties of dental implants. For instance, the "ground truth" for fatigue is whether the implant can withstand 5x10^6 cycles without failure as per ISO 14801. The "ground truth" for biocompatibility is whether it passes cytotoxicity and pyrogen tests per ISO 10993. These are objective, quantifiable standards, not subjective interpretations.

8. The sample size for the training set:

This concept is not applicable. There is no "training set" for a physical dental implant system in the AI/ML sense. The "training" for such a device occurs during its design and manufacturing processes, where iterations and refinements are made to meet engineering specifications and regulatory requirements.

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

This concept is not applicable. Since there is no "training set" in the AI/ML context, there's no ground truth established for it. The "ground truth" for the device's design and manufacturing quality relies on engineering principles, material science, and adherence to quality management systems (e.g., 21 CFR Part 820 Quality System Regulation).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

November 10, 2020

Jiangyin Jintech Biotech Co., Ltd. % Stuart Goldman Senior Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K183044

Trade/Device Name: JTK Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 9, 2020 Received: October 14, 2020

Dear Stuart Goldman:

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183044

Device Name JTK Dental Implant System

Indications for Use (Describe) JTK One-Piece Integrated Implant System:

JTK Two-Piece Implant System:

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

JTK Dental Implant System

1. Submission Sponsor

Jiangyin Jintech Biotech Co., Ltd. Building D1 No.6 Dongshengxi Road 214437 Jiangyin City Jiangsu Province China Contact: Dr. Jie Zhang Title: Founder, Chairman, CEO, General Manager

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Contact: Stuart R. Goldman Title: Senior Consultant RA/QA

3. Date Prepared

November 10, 2020

4. Device Identification

Trade Name:	JTK Dental Implant System
Common Name:	Dental implant
Classification Name:	Endosseous dental implant
Regulation Number:	21 CFR 872.3640
Product Code:	DZE
Secondary Product Code:	NHA
Class:	Class II
Classification Panel:	Dental

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5. Legally Marketed Predicate and Reference Devices for the JTK Dental Implant System:

Primary Predicate Device:

Primary Predicate: T.A.G. Dental Implant System – Crestone (K143326)

Reference Devices:

. Reference Device 1: ANKYLOS C/X Dental Implant System (K083805)
Reference Device 2: Spectra-System Dental Implants 2008 – ScrewPlus (K090234)
. Reference Device 3: Premium Implant Systems-SHELTA Implant Systems - Premium TG (K142242)

6. Indications for Use

JTK One-Piece Integrated Implant System:

JTK Two-Piece Implant System:

The JTK two-piece dental implant system is comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of single tooth or multiple-tooth restorations, recognizing bone stability and appropriate occlusal load requirements.

7. Device Description

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in two different models (straight and angled (15° and 25°). The straight abutments are offered in a diameter of 4.4 mm and in lengths of 4.2, 5.2, 6.2 and 8.2 mm. The 15° angled abutments are offered in a diameter of 4.4 mm and in lengths of 6.0 and 8.0 mm, while the 25° the angled abutments are offered in a diameter of 4.4 mm and in lengths of 6.0 and 10.5 mm.

8. Substantial Equivalence Discussion

The following tables compares the JTK Dental Implant System (one-piece and two-piece designs) to the primary predicate device with respect to its indications for use, materials, surface finish, dimensions, usage, packaging, sterility, biocompatibility, shelf-life and performance testing (fatigue), and provides detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the primary predicate device.

The following additional reference devices were used in this 510(k).

. Reference Device 1 (K083805) – The ANKYLOS C/X Dental Implant System was included as a reference device to show identical raw material (unalloyed grade 2) to the subject one-piece implant system and two-piece implant system. In addition, the abutments used in Reference Device 1 are made from Titanium alloy conforming to ASTM F136, which is the same alloy used to make the abutments in the subject two-piece implant system.
Reference Device 2 (K090234) – The Spectra-System Dental Implants 2008 – ScrewPlus was included as a reference device to show the same implant diameters and lengths to the subject two-piece implant system.
Reference Device 3 (K142242) – The Premium Implant Systems-SHELTA Implant Systems – Premium TG was included as a reference device to show similar SLA surface finish and the same implant diameters and lengths to the to the subject two-piece implant system.

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Attributes	Subject Device	Primary Predicate	Reference Device 1	Similarities / Differences
Device Name	JTK Dental Implant System (One-piece implant)	T.A.G. Dental Implant System – Crestone	ANKYLOS C/X Dental Implant System	-
Manufacturer	Jiangyin Jintech	T.A.G Medical Products	Dentsply Intl., Inc.	-
510(k) #	K183044	K143326	K083805	-
Device Image	Image: JTK Dental Implant	Image: T.A.G. Dental Implant	Image: ANKYLOS C/X Dental Implant	-
Indications for Use	The JTK one-piece dental implant system is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.	The T.A.G. Dental Implant System is intended to replace single or multiple teeth in the fully or partially edentulous mandibular or maxillary alveolar process. The implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.	The ANKYLOS® C/X Dental Implant System is for single- stage or two-stage surgical procedures and cemented or screw retained restorations. The ANKYLOS® C/X Dental Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.	The subject and primary predicate device are indicated for the replacement of single or multiple teeth in the mandible and maxilla bone, and where appropriate, for immediate loading.
Materials	Titanium (unalloyed grade 2)	Titanium (alloy grade 23)	Titanium (unalloyed grade 2)	The subject and primary predicate device are made from different types of titanium. The difference in titanium is addressed by
				introducing ReferenceDevice 1 (K083805),which is also made ofunalloyed grade 2titanium.
Surface Finish	SLA	SLA	SLA	The subject andprimary predicatedevice use similar SLAsurface finishtechnology.
Diameter(mm)	3.0, 3.3	3.0, 3.5	3.5 - 5.5, 7.0	The subject devicediameters fall withinthose of the primarypredicate device.
ThreadedLength (mm)	10.0, 13.0, 15.0	10.0, 11.5, 13.0, 16.0	8 – 17, 8 – 14	The subject devicelengths fall withinthose of the primarypredicate device.
Abutmentdesign	Contoured and polished	Contoured and polished	NA	Similar
Threaddesign	Straight	Tapered	Straight	This difference inthread designsbetween the subjectdevice and theprimary predicatedevice is addressed byintroducing ReferenceDevice 1 (K083805),which also has atapered thread design.
Packaging	Single use; individual vial/PETblister package/cardboard box	Single use; individual vial/PETblister package/cardboard box	Not identified	Similar
Shelf-life	2 years	Not identified	Not identified	-
Attributes	Subject Device	Reference Device 1	Reference Device 2	Reference Device 3	Similarities /Differences
Device Name	JTK Dental ImplantSystem (Two-pieceimplant)	ANKYLOS C/XDental ImplantSystem	Spectra-System DentalImplants 2008 –ScrewPlus	Premium ImplantSystems-SHELTA ImplantSystems – Premium TG
Manufacturer	Jiangyin Jintech	Dentsply Intl., Inc.	Implant Direct SybronInternational, LLC	Sweden & Martina S.p. A
510(k) #	K183044	K083805	K090234	K142242
Device Image	Image: JTK Dental Implant	Image: ANKYLOS C/X Dental Implant	Image: Spectra-System Dental Implant	Image: Premium Implant Systems-SHELTA Implant
Indications forUse	The JTK two-piecedental implant systemis comprised of dentalimplant fixtures andprosthetic devices thatcompose a two-pieceimplant system. Theimplants are intendedfor use in the mandibleand maxilla, in supportof single unit ormultiple unit cementor screw-receivingrestorations and forthe retention andsupport ofoverdentures. Theimplants are intendedfor immediateplacement andfunction for thesupport of single tooth	The ANKYLOS® C/XDental ImplantSystem is for single-stage or two-stagesurgical proceduresand cemented orscrew retainedrestorations. TheANKYLOS® C/XDental ImplantSystem is intendedfor immediateplacement andfunction on singletooth and/ormultiple toothapplications whengood primarystability is achieved,with appropriateocclusal loading, torestore chewing	Spectra-System DentalImplants 2008 arecomprised of dentalimplant fixtures andprosthetic devices thatcompose a two-pieceimplant system. Theimplants are intendedfor use in the mandibleand maxilla, in supportof single unit ormultiple unit cement orscrew-receivingrestorations and for theretention and supportof overdentures. Theimplants are intendedfor immediateplacement and functionfor the support ofsingle tooth ormultiple-tooth	PREMIUM ImplantSystems-SHELTA ImplantSystems (PremiumStraight, Premium TG,Premium SP, Shelta andShelta SL) are intendedfor both one-and two-stage surgicalprocedures.PREMIUM ImplantSystems-SHELTA ImplantSystems are intended forimmediate placementand function on singletooth and/or multipletooth applications whengood primary stability isachieved, withappropriate occlusalloading, in order torestore chewingfunction. Multiple tooth	The subject andprimary predicatedevice (K143326)are indicated forthe replacement ofsingle or multipleteeth in themandible andmaxilla bone, andwhere appropriate,for immediateloading. However,although theprimary predicatedevice haveindications forimmediate loading,the specificwording has beenchosen fromReference Device 2(K090234) due to
or multiple-toothrestorations,recognizing bonestability andappropriate occlusalload requirements.	function. Multipletooth applicationsmay be splintedwith a bar.	restorations,recognizing bonestability andappropriate occlusalload requirements.	applications may besplinted with a bar.Abutments:PREMIUM-SHELTAAbutments are intendedto be used inconjunction with aPREMIUM-SHELTAImplants Systems in fullyedentulous or partiallyedentulous maxillaryand/or mandibulararches.The PREMIUM-SHELTAAbutment is intendedfor use with anendosseous implant tosupport a prostheticdevice in a partially orcompletely edentulouspatient. It is intended foruse to support singleand multiple toothprostheses, inthe mandible or maxilla.The prosthesis can becemented, screwretained, or friction fit tothe abutment. Theabutment screw isintended to secure theabutment to theendosseous implant.PREMIUM-SHELTAAbutments arecompatible withPREMIUM-SHELTAImplants Systems	the substantialequivalencerelated to the two-piece technologicaldifference ascompared to theprimary predicatedevice.

Materials	Titanium (unalloyedgrade 2)	Titanium (unalloyedgrade 2)	Titanium (alloy grade 5)	Commercially puregrade 4 (ASTM F67)	The subject andprimary predicatedevice are madefrom differenttypes of titanium.The difference intitanium isaddressed byintroducingReference Device 1(K083805), which isalso made ofunalloyed grade 2titanium.
Surface Finish	SLA	SLA	SBM (or HA)	SLA	The subject andprimary predicatedevice and usesimilar SLA surfacefinish technology.
Diameter (mm)	3.8, 4.0, 4.5, 5.0, 5.5	3.5 – 5.5, 7.0	3.7, 4.7, 5.7, 6.5	3.3, 3.8, 4.25, 5.0	The subject devicediameters fallwithin those ofReference Device 2(K090234) andReference Device 3(K142242).
Threaded Length(mm)	8.0, 10.0, 13.0, 15.0	8 - 17, 8 - 14	8.0, 10.0, 11.5, 13.0,16.0	6.0, 7.0, 8.5, 10.0,11.5, 13.0, 15.0	The subject devicelengths fall withinthose of ReferenceDevice 2 (K090234)and ReferenceDevice 3(K142242).
Neck Design	Conical-shaped neck;polished	Straight; notpolished	Conical-shaped neck;polished	Conical-shaped neck;polished	Similar
ThreadDesign	Straight with self-tapping blunt end	Straight with self-tapping blunt end	Straight with self-tapping blunt end	Straight with self-tapping blunt end	Similar
	structure	structure	structure	structure
ConnectionType	Internal hex	Keyed alignment,friction-lock taper,thread attachment	Internal hex	Internal hex	Identical
Packaging	Single use; individualvial/PET blisterpackage/cardboardbox	Not identified	Single use; individualvial/PET blisterpackage/cardboard box	Single use; individualvial/PET blisterpackage/cardboard box	Similar
Shelf-life	2 years	Not identified	5 years	Not identified	Similar

Table 5-1 – Comparative Information of JTK One-Piece Implant System - Implants

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Table 5-2 – Comparative Information of JTK Two-Piece Implant System - Implants

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Table 5-3 – Comparative Information of JTK Two-Piece Implant System - Abutments

Table 5-3 - Comparative Information of JTK Two-Piece Implant System - Abutments
Abutments
Attributes	Subject Device	Reference Device 2	Reference Device 3	Similarities / Differences
Device Name	JTK Dental Implant System (Two-piece implant)	Spectra-System Dental Implants 2008 – ScrewPlus	Premium Implant Systems-SHELTA Implant Systems – Premium TG	-
Manufacturer	Jiangyin Jintech	Implant Direct Sybron International, LLC	Sweden & Martina S.p. A	-
510(k) #	K183044	K090234	K142242	-
Device Image	Image: JTK Dental Implant	Image: Spectra-System Dental Implants	Image: Premium Implant Systems	-
Angle	0°/15°/25°	0°/15°	0°/15°/25°	The subject device abutments are of similar shape and identical angles as the abutments used in Reference Device 2 and Reference Device 3.
Materials	Titanium alloy conforming to ASTM F136	Titanium (alloy grade 5)	Not identified	The subject device abutments are made from Titanium alloy conforming to ASTM F136, which is the same alloy used to make the abutments in Reference Device

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				1 (K083805).
Surface Finish	Polished	Polished	Polished	Similar
Diameter (mm)	4.4	3.7, 4.7, 5.7, 6.5	Not identified	Similar. The subject device abutment diameter fallswithin those of Reference Device 2 (K090234).
Length (mm)	4.2, 5.2, 6.0, 6.2,8.0, 8.2, 10.5	5.5, 6.5, 7.5, 8.6,9.6, 10.6	Not identified	Different. While the subject device abutment lengthsof 4.2 and 5.2 mm are lower than the identifiedminimal length of 5.5 mm found in Reference Device 2(K090234), the shorter lengths do not impact thesubstantial equivalence as the minimum length is stilllonger than the clinically recommended 4 mm forsingle unit abutments.
ConnectionType	Internal hex	Internal hex	Internal hex	Identical

Table 5-4 – Comparative Information of JTK Two-Piece Implant System – Healing Cap

Healing Cap
Attributes	Subject Device	Reference Device 2	Similarities / Differences
Device Name	JTK Dental Implant System (Two-piece implant)	Spectra-System Dental Implants 2008 - ScrewPlus	-
Manufacturer	Jiangyin Jintech	Implant DirectSybronInternational, LLC	-
510(k) #	K183044	K090234	-
Device Image	Image: Subject Device	Image: Reference Device 2	-
Materials	Titanium alloy conforming to ASTM F136	Titanium (alloy grade 5)	The subject device abutments are made from Titanium alloy conforming to ASTM F136, which is the same alloy used to make the abutments in Reference Device 1 (K083805).
Diameter (mm)	5.0	3.7, 4.7, 5.7, 6.5	Different. While the subject device healing cap diameter of 5.0 mm is different than the identified diameters found in Reference Device 2 (K090234), this difference does not impact the substantial equivalence as the healing cap is just used to cover the internal hex portion of the conical neck during the healing process only.

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Length (mm)	5.5	5.8	Different. While the subject device healing cap length of 5.5 mm is smaller than the identified length of 5.8 mm found in Reference Device 2 (K090234), the shorter length does not impact the substantial equivalence as the healing cap is just used to cover the internal hex portion of the conical neck during the healing process only.
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Table 5-5 – Comparative Information of JTK Two-Piece Implant System – Attachment Screw (Bolt)

Attachment Screw (Bolt)
Attributes	Subject Device	Reference Device 2	Similarities / Differences
Device Name	JTK Dental ImplantSystem (Two-pieceimplant)	Spectra-SystemDental Implants 2008– ScrewPlus	-
Manufacturer	Jiangyin Jintech	Implant DirectSybron International,LLC	-
510(k) #	K183044	K090234	-
Device Image	Image: JTK Dental Implant System Attachment Screw	Image: Spectra-System Dental Implants Attachment Screw	-
Materials	Titanium alloyconforming toASTM F136	Titanium (alloy grade5)	The subject device abutments are made from Titanium alloy conforming toASTM F136, which is the same alloy used to make the abutments in ReferenceDevice 1 (K083805).
Diameter(mm)	2.45	1.7	Different. The subject device attachment screw diameter is greater than thediameter of the attachment screw in Reference Device 2 (K090234). Thedevice attachment, when used to connect the subject implant and abutment,passed the required fatigue testing in ISO 14801.
Length (mm)	7.8	7.2, 9.7	Different. The subject device attachment screw length of 7.8 mm falls withinthe identified lengths of the attachment screws used in Reference Device 2(K090234). In addition, the device attachment, when used to connect thesubject implant and abutment, passed the required fatigue testing in ISO14801.

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9. Non-Clinical Performance Data

As part of demonstrating substantial equivalence of the JTK Dental Implant System (one-piece models) to the predicate devices (K143326 and K090234), Jiangyin Jintech conducted performance testing on their devices. The JTK Dental Implant System demonstrated substantial equivalence in the testing shown below.

. Biocompatibility Testing per ISO 10993-1 (cytotoxicity (per ISO 10993-5) and rabbit pyrogen test (per ISO 10993-11))
- The subject devices passed all testing O
. Dynamic Fatigue Testing per ISO 14801
- o The subject devices have demonstrated 5x106 cycles without failure
. Sterilization Validation per ISO 11137-1, -2, and -3
- o The subject devices have demonstrated a SAL of 10 via gammaradiation
. Shelf-life Validation per ASTM F1980-07 and Packaging Validation per ISO 11607
- o The subject devices have a stated shelf-life of 2 years
. Risk Analysis per ISO 14971
- The subject devices conform to the ISO standard
. Jiangyin Jintech have addressed all recommendations of the FDA Guidance, "Submission and Review of Sterility Information in Premarket Notifications (510(k)) Submissions for Devices Labeled as Sterile" related to LAL testing for pyrogenicity for their JTK Dental Implant System.

10. Clinical Performance Data

The non-clinical performance testing detailed in this submission supports the substantial equivalence of the subject device to the predicate devices.

11. Statement of Substantial Equivalence

The JTK Dental Implant System and the predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and the diameter and angulation of the abutments. Any minor differences in the technological features of the subject device when compared to the predicate devices have been successfully evaluated through non-clinical performance testing such that the information submitted to the FDA demonstrates that the JTK Dental 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.