(739 days)
No
The device description focuses on traditional manufacturing methods and material properties, with no mention of AI or ML. The performance studies are standard biocompatibility, fatigue, sterilization, and shelf-life tests, not related to AI/ML performance.
No.
The device replaces missing teeth, which is a restorative function, not directly treating a disease or condition to provide therapy.
No
This device is a dental implant system intended to replace teeth; it does not perform any diagnostic function.
No
The device description clearly details physical components made of titanium, including implants, abutments, and healing caps, manufactured using CNC methods and undergoing surface modifications. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for replacing teeth in the alveolar process. This is a surgical procedure performed directly on the patient's body.
- Device Description: The description details the physical components of a dental implant system (implants, abutments, healing caps) and their materials and manufacturing. These are physical devices implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a physical replacement for teeth.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibular or maxillary alveolar process, mandible, maxilla
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- 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.
- Dynamic Fatigue Testing per ISO 14801: The subject devices have demonstrated 5x10^6 cycles without failure.
- Sterilization Validation per ISO 11137-1, -2, and -3: The subject devices have demonstrated a SAL of 10^-6 via gamma radiation.
- Shelf-life Validation per ASTM F1980-07 and Packaging Validation per ISO 11607: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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
2
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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 |
4
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
5
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.
6
| 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 | |||||
| Device 1 (K083805), | |||||
| which is also made of | |||||
| unalloyed grade 2 | |||||
| titanium. | |||||
| Surface Finish | SLA | SLA | SLA | The subject and | |
| primary predicate | |||||
| device use similar SLA | |||||
| surface finish | |||||
| technology. | |||||
| Diameter | |||||
| (mm) | 3.0, 3.3 | 3.0, 3.5 | 3.5 - 5.5, 7.0 | The subject device | |
| diameters fall within | |||||
| those of the primary | |||||
| predicate device. | |||||
| Threaded | |||||
| Length (mm) | 10.0, 13.0, 15.0 | 10.0, 11.5, 13.0, 16.0 | 8 – 17, 8 – 14 | The subject device | |
| lengths fall within | |||||
| those of the primary | |||||
| predicate device. | |||||
| Abutment | |||||
| design | Contoured and polished | Contoured and polished | NA | Similar | |
| Thread | |||||
| design | Straight | Tapered | Straight | This difference in | |
| thread designs | |||||
| between the subject | |||||
| device and the | |||||
| primary predicate | |||||
| device is addressed by | |||||
| introducing Reference | |||||
| Device 1 (K083805), | |||||
| which also has a | |||||
| tapered thread design. | |||||
| Packaging | Single use; individual vial/PET | ||||
| blister package/cardboard box | Single use; individual vial/PET | ||||
| 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 / |
| Differences | |||||
| Device Name | JTK Dental Implant | ||||
| System (Two-piece | |||||
| implant) | ANKYLOS C/X | ||||
| Dental Implant | |||||
| System | Spectra-System Dental | ||||
| Implants 2008 – | |||||
| ScrewPlus | Premium Implant | ||||
| Systems-SHELTA Implant | |||||
| Systems – Premium TG | |||||
| Manufacturer | Jiangyin Jintech | Dentsply Intl., Inc. | Implant Direct Sybron | ||
| 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 | |||||
| Use | 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 | 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 | Spectra-System Dental | ||||
| Implants 2008 are | |||||
| 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 | PREMIUM Implant | ||||
| Systems-SHELTA Implant | |||||
| Systems (Premium | |||||
| Straight, Premium TG, | |||||
| Premium SP, Shelta and | |||||
| Shelta SL) are intended | |||||
| for both one-and two- | |||||
| stage surgical | |||||
| procedures. | |||||
| PREMIUM Implant | |||||
| Systems-SHELTA Implant | |||||
| Systems are intended for | |||||
| immediate placement | |||||
| and function on single | |||||
| tooth and/or multiple | |||||
| tooth applications when | |||||
| good primary stability is | |||||
| achieved, with | |||||
| appropriate occlusal | |||||
| loading, in order to | |||||
| restore chewing | |||||
| function. Multiple tooth | The subject and | ||||
| primary predicate | |||||
| device (K143326) | |||||
| are indicated for | |||||
| the replacement of | |||||
| single or multiple | |||||
| teeth in the | |||||
| mandible and | |||||
| maxilla bone, and | |||||
| where appropriate, | |||||
| for immediate | |||||
| loading. However, | |||||
| although the | |||||
| primary predicate | |||||
| device have | |||||
| indications for | |||||
| immediate loading, | |||||
| the specific | |||||
| wording has been | |||||
| chosen from | |||||
| Reference Device 2 | |||||
| (K090234) due to | |||||
| or multiple-tooth | |||||
| restorations, | |||||
| recognizing bone | |||||
| stability and | |||||
| appropriate occlusal | |||||
| load requirements. | function. Multiple | ||||
| tooth applications | |||||
| may be splinted | |||||
| with a bar. | restorations, | ||||
| recognizing bone | |||||
| stability and | |||||
| appropriate occlusal | |||||
| load requirements. | applications may be | ||||
| splinted with a bar. | |||||
| Abutments: | |||||
| PREMIUM-SHELTA | |||||
| Abutments are intended | |||||
| to be used in | |||||
| conjunction with a | |||||
| PREMIUM-SHELTA | |||||
| Implants Systems in fully | |||||
| edentulous or partially | |||||
| edentulous maxillary | |||||
| and/or mandibular | |||||
| arches. | |||||
| The PREMIUM-SHELTA | |||||
| Abutment is intended | |||||
| for use with an | |||||
| endosseous implant to | |||||
| support a prosthetic | |||||
| device in a partially or | |||||
| completely edentulous | |||||
| patient. It is intended for | |||||
| use to support single | |||||
| and multiple tooth | |||||
| prostheses, in | |||||
| the mandible or maxilla. | |||||
| The prosthesis can be | |||||
| cemented, screw | |||||
| retained, or friction fit to | |||||
| the abutment. The | |||||
| abutment screw is | |||||
| intended to secure the | |||||
| abutment to the | |||||
| endosseous implant. | |||||
| PREMIUM-SHELTA | |||||
| Abutments are | |||||
| compatible with | |||||
| PREMIUM-SHELTA | |||||
| Implants Systems | the substantial | ||||
| equivalence | |||||
| related to the two- | |||||
| piece technological | |||||
| difference as | |||||
| compared to the | |||||
| primary predicate | |||||
| device. | |||||
| Materials | Titanium (unalloyed | ||||
| grade 2) | Titanium (unalloyed | ||||
| grade 2) | Titanium (alloy grade 5) | Commercially pure | |||
| grade 4 (ASTM F67) | The subject and | ||||
| primary predicate | |||||
| device are made | |||||
| from different | |||||
| types of titanium. | |||||
| The difference in | |||||
| titanium is | |||||
| addressed by | |||||
| introducing | |||||
| Reference Device 1 | |||||
| (K083805), which is | |||||
| also made of | |||||
| unalloyed grade 2 | |||||
| titanium. | |||||
| Surface Finish | SLA | SLA | SBM (or HA) | SLA | The subject and |
| primary predicate | |||||
| device and use | |||||
| similar SLA surface | |||||
| finish 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 device |
| diameters fall | |||||
| within those of | |||||
| Reference Device 2 | |||||
| (K090234) and | |||||
| Reference 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 device | ||||
| lengths fall within | |||||
| those of Reference | |||||
| Device 2 (K090234) | |||||
| and Reference | |||||
| Device 3 | |||||
| (K142242). | |||||
| Neck Design | Conical-shaped neck; | ||||
| polished | Straight; not | ||||
| polished | Conical-shaped neck; | ||||
| polished | Conical-shaped neck; | ||||
| polished | Similar | ||||
| Thread | |||||
| Design | 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 | ||
| Connection | |||||
| Type | Internal hex | Keyed alignment, | |||
| friction-lock taper, | |||||
| thread attachment | Internal hex | Internal hex | Identical | ||
| Packaging | Single use; individual | ||||
| vial/PET blister | |||||
| package/cardboard | |||||
| box | Not identified | Single use; individual | |||
| vial/PET blister | |||||
| package/cardboard box | Single use; individual | ||||
| vial/PET blister | |||||
| package/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 falls |
| within 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 lengths | ||
| of 4.2 and 5.2 mm are lower than the identified | ||||
| minimal length of 5.5 mm found in Reference Device 2 | ||||
| (K090234), the shorter lengths do not impact the | ||||
| substantial equivalence as the minimum length is still | ||||
| longer than the clinically recommended 4 mm for | ||||
| single unit abutments. | ||||
| Connection | ||||
| Type | 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 Direct | |
| Sybron | |||
| International, 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. |
|---|---|---|---|
| ------------- | ----- | ----- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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 Implant | ||
| System (Two-piece | |||
| implant) | Spectra-System | ||
| Dental Implants 2008 | |||
| – ScrewPlus | - | ||
| Manufacturer | Jiangyin Jintech | Implant Direct | |
| Sybron International, | |||
| LLC | - | ||
| 510(k) # | K183044 | K090234 | - |
| Device Image | Image: JTK Dental Implant System Attachment Screw | Image: Spectra-System Dental Implants Attachment Screw | - |
| Materials | Titanium alloy | ||
| conforming to | |||
| ASTM F136 | Titanium (alloy grade |
-
| 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) | 2.45 | 1.7 | Different. The subject device attachment screw diameter is greater than the
diameter of the attachment screw in Reference Device 2 (K090234). The
device 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 within
the identified lengths of the attachment screws used in Reference Device 2
(K090234). In addition, the device attachment, when used to connect the
subject implant and abutment, passed the required fatigue testing in ISO
14801. |
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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.