(484 days)
Not Found
No
The summary describes a dental implant system made of titanium alloy with a specific surface treatment (SLA). There is no mention of software, algorithms, image processing, or any terms related to AI or ML. The performance studies focus on material properties, biocompatibility, and sterilization, not algorithmic performance.
Yes
The device is a dental implant system surgically placed to replace missing teeth, which is a therapeutic intervention.
No
This device, the J2A SLA Dental Implant System, is an implantable medical device used to replace missing teeth, not to diagnose medical conditions or diseases.
No
The device description explicitly states it is a "dental implant system" made of "Titanium 6AL 4V ELI alloy" intended to be "surgically placed in the bone," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device surgically placed in the bone to support dental restorations. This is a surgical implant, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implant made of titanium alloy, designed for surgical placement.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health condition. The performance studies focus on the physical and biological compatibility of the implant itself.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The J2A SLA Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The J2A SLA Dental Implant System is internal hexagon type dental implant systems made of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with SLA (sandblasted, Large-grit, Acid-etched). The size information is as below.
- 3.75mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- 4.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- 4.30mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- 4.50mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- 5.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- 5.50mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- 6.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous mandibles and maxillae
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)
Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification which is surface treatment change from RBM to SLA for fixtures. Through risk analysis and the following validation/verification tests, we conclude that the J2ASLA Dental Implant System is substantially equivalent to the unmodified device.
The following tests were carried out:
- SEM surface analysis
- EDS Surface chemistry analysis
- Cytotoxicity test (10993-5)
- Skin sensitization test (10993-10)
- Intracutaneous reactivity test (10993-10)
- Sterilization validation test (ISO 11137-1 & ISO 11137-2)
- Shelf life validation test: visual inspection, label, seal inspections (ASTMF88), dye penetration (ISO 11607-1 & 11607-2) and microbial challenge (ISO11737-2). Fatigue testing was not conducted because the subject device does not have an angled abutment.
The USP test method will be used to evaluate pyrogen limit specifications for the subject device. The endotoxin testing will be conducted on every batch for the subject device and the testing limit will be below 0.5 EU/mL. We referenced the USP 39 to device on the endotoxin limit which is 0.5 EU/mL.
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.
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and health.
Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 9, 2017
KJ Meditech Co., Ltd. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92620
Re: K161923
Trade/Device Name: J2A SLA Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: October 7, 2017 Received: October 10, 2017
Dear Priscilla Chung:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161923
Device Name J2A SLA Dental Implant System
Indications for Use (Describe)
The J2A SLA Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. These systems are intended for delayed loading.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary (K161923)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 11/09/2017
1. Submitter
| Submitter | |
|---|---|
| Name | KJ Meditech Co., Ltd. |
| Address | 21, Cheomdan Venture-ro |
| 40 Beon-gil, Buk-gu | |
| Gwangju, Jeonranamdo, Republic of Korea 500-470 | |
| Phone | +82-62-972-5476 |
| Fax | +82-62-973-2809 |
| Contact | Huykki Moon, CEO |
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: J2A SLA Dental Implant System ●
- Common Name: Dental Implant System
- Classification Name: Endosseous Dental Implant System ●
- Product Code: DZE, NHA ●
- . Classification regulation: 21CFR872.3640
4. Predicate Device:
J2A Dental Implant System, J2C Dental Implant System (K150060) by KJ Meditech Co., Ltd.
5. Description:
The J2A SLA Dental Implant System is internal hexagon type dental implant systems made
4
of Titanium 6AL 4V ELI alloy intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The system is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The surface of the system has been treated with SLA (sandblasted, Large- grit, Acid-etched). The size information is as below.
- · 3.75mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- · 4.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- · 4.30mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- · 4.50mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- 5.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L) · 5.50mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
- · 6.00mm Dia. x 7mm(L) / 8.5mm (L) / 10.0mm(L) / 13.0mm(L) / 13.0mm(L) / 15mm(L)
6. Indication for use:
The J2A SLA Dental Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The J2A SLA Dental Implant System is for single and two stage surgical procedures. The system is intended for delayed loading.
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7. Basis for Substantial Equivalence
| Item | Subject Device | Predicate Device | Appearance | Image: Dental implants with SLA Treatment | Image: Dental implants with RBM Treatment |
|---|---|---|---|---|---|
| 510(K) Number | - | K150060 | Endosseous Implant | ||
| Material | Ti 6A1 4V ELI, ASTM F136 | Ti 6Al 4V ELI, ASTM F136 | |||
| Device Name | J2A SLA Dental Implant | J2A Dental Implant System, | |||
| J2C Dental Implant System | Surface Treatment | SLA Treatment | RBM Treatment | ||
| Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. | Sterilization Method | Gamma | Gamma |
| Indications for Use | The J2A SLA Dental Implant | ||||
| System is indicated for use in | |||||
| partially or fully edentulous | |||||
| mandibles and maxillae, in | |||||
| support of single or multiple- | |||||
| unit restorations including; | |||||
| cemented retained, screw | |||||
| retained, or overdenture | |||||
| restorations, and terminal or | |||||
| intermediate abutment | |||||
| support for fixed bridgework. | |||||
| The J2A SLA Dental Implant | |||||
| is for single and two stage | |||||
| surgical procedures. The | |||||
| system is intended for | |||||
| delayed loading. | The J2A Dental Implant | ||||
| System, J2C Dental Implant | |||||
| System are indicated for use | |||||
| in partially or fully | |||||
| edentulous mandibles and | |||||
| maxillae, in support of | |||||
| single or multiple-unit | |||||
| restorations including; | |||||
| cemented retained, screw | |||||
| retained, or overdenture | |||||
| restorations, and terminal or | |||||
| intermediate abutment | |||||
| support for fixed | |||||
| bridgework. The J2A Dental | |||||
| Implant System, J2C Dental | |||||
| Implant System are for | |||||
| single and two stage surgical | |||||
| procedures. These systems | |||||
| are intended for delayed | |||||
| loading. | Implant Diameters | 3.75mm, 4.0mm, 4.3mm, | |||
| 4.5mm, 5.0 mm, 5.5mm, | |||||
| 6.0mm | 3.75mm, 4.0mm, 4.3mm, | ||||
| 4.5mm, 5.0 mm, 5.5mm, | |||||
| 6.0mm | |||||
| Design | • Implant Type: Bone Level | ||||
| Implant | |||||
| • Connection Type: Internal | |||||
| Hexagon | |||||
| • Neck Design: Straight | |||||
| walled neck | |||||
| • Body Design: Tapered | |||||
| design | • Implant Type: Bone Level | ||||
| Implant | |||||
| • Connection Type: Internal | |||||
| Hexagon | |||||
| • Neck Design: Straight | |||||
| walled neck with micro- | |||||
| thread | |||||
| • Body Design: Tapered | |||||
| design | Implant Lengths | 7mm – 15.0 mm | 7mm – 15.0 mm |
The J2A SLA Dental Implant System has the same intended use and technical characteristics as the unmodified device. They are exactly identical except the surface treatment.
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8. Non-Clinical Testing
Risk analysis was conducted according to ISO14971 to evaluate the effect of the modification which is surface treatment change from RBM to SLA for fixtures. Through risk analysis and the following validation/verification tests, we conclude that the J2ASLA Dental Implant System is substantially equivalent to the unmodified device.
The following tests were carried out:
-
SEM surface analysis
-
EDS Surface chemistry analysis
-
Cytotoxicity test (10993-5)
-
Skin sensitization test (10993-10)
-
Intracutaneous reactivity test (10993-10)
-
Sterilization validation test (ISO 11137-1 & ISO 11137-2)
-
Shelf life validation test: visual inspection, label, seal inspections (ASTMF88), dye penetration (ISO 11607-1 & 11607-2) and microbial challenge (ISO11737-2). Fatigue testing was not conducted because the subject device does not have an angled abutment.
The USP test method will be used to evaluate pyrogen limit specifications for the subject device. The endotoxin testing will be conducted on every batch for the subject device and the testing limit will be below 0.5 EU/mL. We referenced the USP 39 to device on the endotoxin limit which is 0.5 EU/mL.
9. Conclusion
The subject devices and the predicate device have the same intended use and have the same technological characteristics.
7
Overall, the J2A SLA Dental Implant system has the following similarities to the predicate device:
-
- have the same intended use,
-
- use the same operating principle,
-
- incorporate the same design,
-
- incorporate the same material and the sterilization method.
Based on the similarities, we conclude that the J2A SLA Dental Implant system is substantially equivalent to the predicate device.