JTK Dental Implant System

K183044 · Jiangyin Jintech Biotech Co., Ltd. · DZE · Nov 10, 2020 · Dental

Device Facts

• Record ID: K183044
• Device Name: JTK Dental Implant System
• Applicant: Jiangyin Jintech Biotech Co., Ltd.
• Product Code: DZE · Dental
• Decision Date: Nov 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

JTK One-Piece Integrated Implant System: 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 Story

JTK Dental Implant System comprises one-piece integrated implants and two-piece implant systems (fixtures, abutments, healing caps, attachment screws). One-piece system: implant and abutment machined from single piece of titanium. Two-piece system: separate implant and abutment connected via screw. Used in mandible/maxilla for tooth replacement/restoration support. Operated by dental professionals in clinical settings. Implants feature threaded bodies with SLA (sandblasted, acid-etched) surface modification. Two-piece system uses internal hex connection. Devices supplied sterile via gamma radiation. Clinical benefit: restoration of chewing function and dental aesthetics. Healthcare providers use clinical judgment and radiographic assessment to determine placement and loading suitability based on bone stability.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by non-clinical bench testing: biocompatibility (ISO 10993-5/11), dynamic fatigue testing (ISO 14801, 5x10^6 cycles), sterilization validation (ISO 11137, SAL 10^-6), and shelf-life/packaging validation (ASTM F1980-07, ISO 11607).

Technological Characteristics

Materials: Unalloyed titanium (ASTM F67) for implants; Ti-6Al-4V ELI alloy (ASTM F136) for abutments/screws. Surface: SLA (sandblasted, acid-etched). Connection: Internal hex (two-piece). Manufacturing: CNC machining. Sterilization: Gamma radiation. Form factor: Threaded implants (various diameters/lengths), straight/angled abutments.

Indications for Use

Indicated for replacement of single or multiple teeth in fully or partially edentulous mandibular or maxillary alveolar process. Appropriate for immediate loading/placement when primary stability and occlusal load requirements are met. Supports single/multiple unit cement or screw-retained restorations and overdentures.

Regulatory Classification

Identification

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

Special Controls

*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2) *Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use; (ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads; (iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system; (iv) The device must be demonstrated to be biocompatible; (v) Sterility testing must demonstrate the sterility of the device; (vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment; (vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians; (viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and (ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.

Predicate Devices

• T.A.G. Dental Implant System – Crestone (K143326)

Reference Devices

• ANKYLOS C/X Dental Implant System (K083805)
• Spectra-System Dental Implants 2008 – ScrewPlus (K090234)
• Premium Implant Systems-SHELTA Implant Systems - Premium TG (K142242)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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:

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: overline;">X</span> 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: [phone] 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:

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 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

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

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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.

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.

# 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 Reference<br>Device 1 (K083805),<br>which is also made of<br>unalloyed grade 2<br>titanium. | |
| Surface Finish | SLA | SLA | SLA | The subject and<br>primary predicate<br>device use similar SLA<br>surface finish<br>technology. | |
| Diameter<br>(mm) | 3.0, 3.3 | 3.0, 3.5 | 3.5 - 5.5, 7.0 | The subject device<br>diameters fall within<br>those of the primary<br>predicate device. | |
| Threaded<br>Length (mm) | 10.0, 13.0, 15.0 | 10.0, 11.5, 13.0, 16.0 | 8 – 17, 8 – 14 | The subject device<br>lengths fall within<br>those of the primary<br>predicate device. | |
| Abutment<br>design | Contoured and polished | Contoured and polished | NA | Similar | |
| Thread<br>design | Straight | Tapered | Straight | This difference in<br>thread designs<br>between the subject<br>device and the<br>primary predicate<br>device is addressed by<br>introducing Reference<br>Device 1 (K083805),<br>which also has a<br>tapered thread design. | |
| Packaging | Single use; individual vial/PET<br>blister package/cardboard box | Single use; individual vial/PET<br>blister 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 /<br>Differences |
| Device Name | JTK Dental Implant<br>System (Two-piece<br>implant) | ANKYLOS C/X<br>Dental Implant<br>System | Spectra-System Dental<br>Implants 2008 –<br>ScrewPlus | Premium Implant<br>Systems-SHELTA Implant<br>Systems – Premium TG | |
| Manufacturer | Jiangyin Jintech | Dentsply Intl., Inc. | Implant Direct Sybron<br>International, 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 for<br>Use | The JTK two-piece<br>dental implant system<br>is comprised of dental<br>implant fixtures and<br>prosthetic devices that<br>compose a two-piece<br>implant system. The<br>implants are intended<br>for use in the mandible<br>and maxilla, in support<br>of single unit or<br>multiple unit cement<br>or screw-receiving<br>restorations and for<br>the retention and<br>support of<br>overdentures. The<br>implants are intended<br>for immediate<br>placement and<br>function for the<br>support of single tooth | The ANKYLOS® C/X<br>Dental Implant<br>System is for single-<br>stage or two-stage<br>surgical procedures<br>and cemented or<br>screw retained<br>restorations. The<br>ANKYLOS® C/X<br>Dental Implant<br>System is intended<br>for immediate<br>placement and<br>function on single<br>tooth and/or<br>multiple tooth<br>applications when<br>good primary<br>stability is achieved,<br>with appropriate<br>occlusal loading, to<br>restore chewing | Spectra-System Dental<br>Implants 2008 are<br>comprised of dental<br>implant fixtures and<br>prosthetic devices that<br>compose a two-piece<br>implant system. The<br>implants are intended<br>for use in the mandible<br>and maxilla, in support<br>of single unit or<br>multiple unit cement or<br>screw-receiving<br>restorations and for the<br>retention and support<br>of overdentures. The<br>implants are intended<br>for immediate<br>placement and function<br>for the support of<br>single tooth or<br>multiple-tooth | PREMIUM Implant<br>Systems-SHELTA Implant<br>Systems (Premium<br>Straight, Premium TG,<br>Premium SP, Shelta and<br>Shelta SL) are intended<br>for both one-and two-<br>stage surgical<br>procedures.<br>PREMIUM Implant<br>Systems-SHELTA Implant<br>Systems are intended for<br>immediate placement<br>and function on single<br>tooth and/or multiple<br>tooth applications when<br>good primary stability is<br>achieved, with<br>appropriate occlusal<br>loading, in order to<br>restore chewing<br>function. Multiple tooth | The subject and<br>primary predicate<br>device (K143326)<br>are indicated for<br>the replacement of<br>single or multiple<br>teeth in the<br>mandible and<br>maxilla bone, and<br>where appropriate,<br>for immediate<br>loading. However,<br>although the<br>primary predicate<br>device have<br>indications for<br>immediate loading,<br>the specific<br>wording has been<br>chosen from<br>Reference Device 2<br>(K090234) due to |
| or multiple-tooth<br>restorations,<br>recognizing bone<br>stability and<br>appropriate occlusal<br>load requirements. | function. Multiple<br>tooth applications<br>may be splinted<br>with a bar. | restorations,<br>recognizing bone<br>stability and<br>appropriate occlusal<br>load requirements. | applications may be<br>splinted with a bar.<br>Abutments:<br>PREMIUM-SHELTA<br>Abutments are intended<br>to be used in<br>conjunction with a<br>PREMIUM-SHELTA<br>Implants Systems in fully<br>edentulous or partially<br>edentulous maxillary<br>and/or mandibular<br>arches.<br>The PREMIUM-SHELTA<br>Abutment is intended<br>for use with an<br>endosseous implant to<br>support a prosthetic<br>device in a partially or<br>completely edentulous<br>patient. It is intended for<br>use to support single<br>and multiple tooth<br>prostheses, in<br>the mandible or maxilla.<br>The prosthesis can be<br>cemented, screw<br>retained, or friction fit to<br>the abutment. The<br>abutment screw is<br>intended to secure the<br>abutment to the<br>endosseous implant.<br>PREMIUM-SHELTA<br>Abutments are<br>compatible with<br>PREMIUM-SHELTA<br>Implants Systems | the substantial<br>equivalence<br>related to the two-<br>piece technological<br>difference as<br>compared to the<br>primary predicate<br>device. | |
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