(294 days)
Not Found
No
The summary describes a standard dental implant system and does not mention any AI or ML components or functionalities.
Yes
The device, a dental implant system, is intended to support restorations and replace missing teeth, which directly contributes to the treatment or amelioration of a disease or condition (tooth loss) in humans.
No
The device description indicates that the KJ External Implant System is a dental implant system intended for surgical placement in the bone to replace missing teeth, and the intended use specifies its role in supporting restorations. There is no mention of it being used to diagnose a medical condition or disease.
No
The device description clearly 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, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to support dental restorations in the jawbone. This is a surgical and prosthetic application, not a diagnostic test performed on samples from the body.
- Device Description: The device is a dental implant made of titanium alloy, designed to be surgically placed in the bone. This is a physical implant, not a reagent, instrument, or system used to examine specimens.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health condition.
- Performance Studies: The performance studies focus on sterilization, shelf life, and material analysis, which are relevant to the safety and quality of a surgical implant, not the performance of a diagnostic test.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
KJ External 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. KJ External Implant System is for stage surgical procedures. It is intended for delayed loading.
Product codes
DZE, NHA
Device Description
The KJ External Implant System is a dental implant system 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 implants has been treated with R.B.M (Resorbable Blast Media). The KJ External Implant is offered in the following sizes.
Material: Ti 6A1 4V ELI, ASTM F136
Dia.(mm) ⌀3.3, Length(mm) 8.0, 10.0, 11.5, 13.0, 16.0, 18.0
Dia.(mm) ⌀3.8, Length(mm) 8.0, 10.0, 11.5, 13.0, 16.0, 18.0
Dia.(mm) ⌀4.0, Length(mm) 8.0, 10.0, 11.5, 13.0, 16.0, 18.0
Dia.(mm) ⌀4.5, Length(mm) 8.0, 10.0, 11.5, 13.0, 16.0, 18.0
Dia.(mm) ⌀5.0, Length(mm) 8.0, 10.0, 11.5, 13.0, 16.0, 18.0
Dia.(mm) ⌀5.1, Length(mm) 8.0, 10.0, 11.5, 13.0, 16.0, 18.0
Dia.(mm) ⌀6.0, Length(mm) 8.0, 10.0, 11.5, 13.0, 16.0, 18.0
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
Non-Clinical Testing:
- Sterilization validating testing has been performed in accordance with ISO 11137. ISO 11737-1 & ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
- Three year of shelf life has been validated through accelerating testing.
- Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixtures.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be made of flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 30, 2014
KJ Meditech Co., Ltd. c/o Priscilla Juhee Chung LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831
Re: K140051
Trade/Device Name: KJ External Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE, NHA Dated: September 23, 2014 Received: September 29, 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.
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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 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/Resourcesfor You/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 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 yours,
Susan Runno DDS, MA
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
KJ External Implant System
Indications for Use (Describe)
KJ External 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. KJ External Implant System is for stage surgical procedures. It is 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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510(k) Summary (K140051)
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 10/29/2014
1. Applicant / Submitter
KJ Meditech Co., Ltd. 959-21 Daechon-dong, Buk-gu, Gwang-ju, 500-470, South Korea Tel: +82-62-972-5476 Fax: +82-62-973-2809
2. US Agent / Submission Contact Person
LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- . Trade Name: KJ External Implant System
- Common Name: Dental Implant System ●
- Classification Name: Endosseous Dental Implant System ●
- Product Code: DZE, NHA
- Classification regulation: 21CFR872.3640
4. Predicate Device:
US SYSTEM by Osstem Implant Co., Ltd. (K062030) Hero II Dental Implant System, IS Dental Implant System by KJ Meditech Co., Ltd. (K121047)
5. Description:
The KJ External Implant System is a dental implant system 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
4
claims, the material composition employed and performance characteristics. The surface of the implants has been treated with R.B.M (Resorbable Blast Media). The KJ External Implant is offered in the following sizes.
| Material: Ti 6A1 4V ELI, ASTM F136 | |
|---|---|
| Dia.(mm) | Length(mm) |
| ⌀3.3 | 8.0 |
| 10.0 | |
| 11.5 | |
| 13.0 | |
| 16.0 | |
| 18.0 | |
| ⌀3.8 | 8.0 |
| 10.0 | |
| 11.5 | |
| 13.0 | |
| 16.0 | |
| 18.0 | |
| ⌀4.0 | 8.0 |
| 10.0 | |
| 11.5 | |
| 13.0 | |
| 16.0 | |
| 18.0 | |
| ⌀4.5 | 8.0 |
| 10.0 | |
| 11.5 | |
| 13.0 | |
| 16.0 | |
| 18.0 | |
| ⌀5.0 | 8.0 |
| 10.0 | |
| 11.5 | |
| 13.0 | |
| 16.0 | |
| 18.0 | |
| ⌀5.1 | 8.0 |
| 10.0 | |
| 11.5 | |
| 13.0 | |
| 16.0 | |
| 18.0 | |
| ⌀6.0 | 8.0 |
| 10.0 | |
| 11.5 | |
| 13.0 | |
| 16.0 | |
| 18.0 |
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6. Indication for use:
The KJ External 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. KJ External Implant System is for single and two stage surgical procedures. It is intended for delayed loading.
7. Basis for Substantial Equivalence
Similarities
The KJ External Implant System has the same intended use as the identified predicate device (K062030). The KJ External Implant System and US System are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with RBM roughened surfaces. They all share same external hexagon abutment connection system with external beveled interface for maximum prosthetic stability. The subject and predicate devices are both bone-level implants that share similar neck design and cutting edge.
Difference
The difference is the body shape: the subject device has straight body. whereas the predicate device (K062030) has semi-tapered shape. However this is only the minor design factor, so it does not raise new questions on safety and effectiveness of the subject device.
8. Non-Clinical Testing
- . Sterilization validating testing has been performed in accordance with ISO 11137. ISO 11737-1 & ISO 11737-2 for gamma sterilization and ISO 17665-1 and ISO 17665-2 for steam sterilization.
- Three year of shelf life has been validated through accelerating testing. .
- . Chemical and SEM image analyses have been performed to verify that there is no residual after RBM treatment on the fixtures.
9. Conclusion
The subject devices and the predicate devices have the same intended use and have similar technological characteristics. The subject and predicate implants are all made of commercially pure titanium and have the same surface treatments.
Overall, the KJ External Implant System has the following similarities to the predicate devices:
-
- has the same intended use,
-
- uses the same operating principle,
-
- incorporates the same basic design,
-
- incorporates the same material and the surface treatment.
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Based on the similarities, we conclude that the KJ External Implant System is substantially equivalent to the predicate device.