(462 days)
Not Found
No
The summary describes a standard dental implant system made of titanium, with no mention of AI or ML capabilities in its intended use, device description, or performance studies.
Yes
The device is an implant system designed to replace missing teeth and support various restorations, which are therapeutic interventions. Its components are placed surgically in the bone to treat edentulism.
No.
The device description indicates that the JR Implant System is surgically placed in the bone to replace missing teeth and support restorations. It is a prosthetic device for treatment, not for diagnosing conditions.
No
The device description clearly states the device is made of Titanium 6AL 4V ELI alloy and is intended to be surgically placed in bone, indicating it is a physical implant, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The JR Implant System is a surgically implanted device made of titanium. Its intended use is to be placed in the bone of the jaw to support dental restorations. This is a physical implant used in vivo (within the body), not a test performed in vitro (outside the body) on a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes related to disease or condition identification.
Therefore, the JR Implant System falls under the category of a medical device, specifically a dental implant, and not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The JR 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 JR Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The JR Implant system is 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 systems are 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 implant has been treated with R.B.M (Resorbable Blast Media).
The fixtures are offered in the following length and diameter.
- Narrow Platform Fixture: 3.5mm Dia. x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 16.6mm(L)
- Regular Platform Fixture : 4.3 mm Dia. x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 13.6mm(L)
- Wide Platform Fixture : 5.0mm Dia x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 16.6mm(L)
- 6.0 Platform Fixture : 6.0mm Dia. x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 13.6mm(L)
There are five different types of abutments offered and they are provided straight only.
- Esthetic Abutment
- EZ Abutment
- Healing Abutment
- Cover Screw
- Temporary Abutment
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Biocompatibility testing on the proposed JR Implant System has been completed. The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed: ISO Cytotoxicity, ISO Sensitization, ISO Intracutaneous reactivity. Sterilization validation and surface treatment analysis were also conducted on JR 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.
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
510(K) SUMMARY
(K130694)
- Submitter / Applicant:
June / 1 8/2014
KJ Meditech Co., Ltd.
959-21 Daechon-dong, Buk-gu, Gwang-ju, 500-470, South Korea Phone : +82-62-972-5476 Fax : +82-62-973-2809
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831 Tel: 714-202-5789 Email: juhee.c@lkconsultinggroup.com
3. Device Name :
| Trade Name | : | JR Implant System |
|---|---|---|
| Common Names | : | Abutment, Dental, Endosseous implant |
| Classification Name | : | Implant, Endosseous, Root-Form |
| Regulation | : | 21 CFR 872.3640, DZE |
4. Predicate Device :
NobelReplace Tapered Conical Connection (K062566) Manufactured by Nobel Biocare USA LLC
5. Device Description :
The JR Implant system is 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 systems are similar to
510(k) Summary
1
KJ Meditech Co., Ltd
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 implant has been treated with R.B.M (Resorbable Blast Media).
The fixtures are offered in the following length and diameter.
- Narrow Platform Fixture: 3.5mm Dia. x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 16.6mm(L)
- Regular Platform Fixture : 4.3 mm Dia. x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 13.6mm(L)
- Wide Platform Fixture : 5.0mm Dia x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 16.6mm(L)
- 6.0 Platform Fixture : 6.0mm Dia. x 8.6mm(L) / 12.1mm(L) / 13.6mm(L) / 13.6mm(L)
There are five different types of abutments offered and they are provided straight only.
- Esthetic Abutment
- EZ Abutment
- Healing Abutment
- Cover Screw
- Temporary Abutment
5 Intended For Use :
The JR 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 JR Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(K) Number | N/A | K062566 |
| Device Name | JR Implant System | NobelReplace Tapered Conical Connection |
| Manufacturer | KJ Meditech Co., Ltd. | Nobel Biocare USA LLC |
| Indications for Use | Intended for use in partially or fully | |
| edentulous mandibles and maxillae, in | ||
| support of single or multiple-unit | ||
| restorations including; cement-retained, | ||
| screw-retained, or overdenture restorations. | ||
| and terminal or intermediate abutment | ||
| support for fixed bridgework. | Intended for use in partially or fully | |
| edentulous mandibles and maxillae, in | ||
| support of single or multiple-unit | ||
| restorations including; cement-retained, | ||
| screw-retained, or overdenture restorations, | ||
| and terminal or intermediate abutment | ||
| support for fixed bridgework. | ||
| Design | • Implant Type: Bone Level Implant | |
| • Connection Type: Internal tri-lobe | ||
| connection | ||
| • Neck Design: Straight walled neck with | ||
| micro-thread provides crestal seal. | ||
| • Body Design: Tapered design enables | ||
| placement near impringing anatomical | ||
| structures while maximizing prosthetic | ||
| table diameter for natural emergence | ||
| profile. | • Implant Type: Bone Level Implant | |
| • Connection Type: Internal tri-channel | ||
| connection | ||
| • Neck Design: Straight walled neck with | ||
| circumferential thread provides crestal | ||
| seal. | ||
| • Body Design: Tapered design enables | ||
| placement near impringing anatomical | ||
| structures while maximizing prosthetic | ||
| table diameter for natural emergence | ||
| Fixture | ||
| Appearance | Image: Implant with RBM Treatment on the fixture body | Image: Implant with TiUnite surface treatment |
| Fixture Surface | ||
| Treatment | RBM Treatment on the fixture body | TiUnite® surface treatment. |
| Fixture Material | Ti 6Al 4V ELI, ASTM F136 | Pure titanium, ASTM F67 |
| Fixture Sterile | Yes | Yes |
| Sterilization Method | Gamma | Gamma |
| Fixture Diameters | 3.5mm 4.3mm 5.0mm 6.0mm | 3.5mm 4.3mm 5.0mm 6.0mm |
| Fixture Lengths | 8mm - 16.0 mm | 8mm - 16.0 mm |
| Abutment Surface | ||
| Treatment | Anodizing | Anodizing |
| Abutment material | Ti 6Al 4V ELI, ASTM F136 | Pure titanium, ASTM F67 |
| Cover screw Surface | ||
| Treatment | Anodizing | Anodizing |
| Cover screw material | Ti 6Al 4V ELI, ASTM F136 | Pure titanium, ASTM F67 |
| Healing Abut Surface | ||
| Treatment | Anodizing | Anodizing |
| Healing Abut material | Ti 6Al 4V ELI, ASTM F136 | Pure titanium, ASTM F67 |
| Temporary Abut Surface | ||
| Treatment | Anodizing | Anodizing |
| Temporary Abut material | Ti 6Al 4V ELI, ASTM F136 | Pure titanium, ASTM F67 |
| Abutment | ||
| Type | For Narrow Platform Fixture | |
| For Regular Platform Fixture | ||
| For Wide Platform Fixture | ||
| For 6.0 Platform Fixture | For Narrow Platform Fixture | |
| For Regular Platform Fixture | ||
| For Wide Platform Fixture | ||
| For 6.0 Platform Fixture | ||
| Cover Screw Type | For Narrow Platform Fixture | |
| For Regular Platform Fixture | ||
| For Wide Platform Fixture | ||
| For 6.0 Platform Fixture | For Narrow Platform Fixture | |
| For Regular Platform Fixture | ||
| For Wide Platform Fixture | ||
| For 6.0 Platform Fixture | ||
| Healing Abut Type | For Narrow Platform Fixture | |
| For Regular Platform Fixture | ||
| For Wide Platform Fixture | For Narrow Platform Fixture | |
| For Regular Platform Fixture | ||
| For Wide Platform Fixture | ||
| For 6.0 Platform Fixture | For 6.0 Platform Fixture | |
| Temporary Abutment | For Narrow Platform Fixture | |
| For Regular Platform Fixture | ||
| For Wide Platform Fixture | ||
| For 6.0 Platform Fixture | For Narrow Platform Fixture | |
| For Regular Platform Fixture | ||
| For Wide Platform Fixture | ||
| For 6.0 Platform Fixture | ||
| Product Code | DZE | DZE |
6. Substantial Equivalence :
2
KJ Meditech Co., Ltd
510(k) Summary
An - Relation of a 1
Page 3 of 4
3
KJ Meditech Co., Ltd
The JR Implant system is substantially equivalent in intended use, design and performance to the predicate devices.
The differences between the subject device and the predicate device are the titanium grade and surface treatment of the fixture; however, testing data such as biocompatibility testing provided in the submission proves that this difference would not raise issues in safety and performance. Therefore, we claim that the proposed device is substantially equivalent to the predicate device.
7. Performance Testing
· Biocompatibility testing on the proposed JR Implant System has been completed.
The biocompatibility test results show that the materials used in the design and manufacture of the components of the proposed device are non-toxic and non-sensitizing to biological tissues consistent with its intended use. The following biocompatibility tests were completed.
-ISO Cytotoxicity
-ISO Sensitization
-ISO Intracutaneous reactivity
· Sterilization validation and surface treatment analysis were also conducted on JR Implant System.
8. Conclusion
Based on the information provided in this premarket notification KJ Meditech Co., Ltd concludes that the JR Implant System is substantially equivalent to the predicate device as described herein.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains an emblem of an eagle with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the top and left side of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2014
KJ Meditech Co., Ltd. C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton, CA 92833
Re: K130694
Trade/Device Name: JR Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 14, 2014 Received: May 20, 2014
Dear Ms. 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.
5
Page 2 - Ms. Chung
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for use Statement
K130694 510(k) Number ( If known ) :
Device Name : JR Implant System
Indication for use :
The JR 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 JR Implant System is for single and two stage surgical procedures. These systems are intended for delayed loading.
Prescription Use ---------X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Green -S 2014.06.19 10:58:57 -04'00'
Indication for use statement
Page 1 of 1