(463 days)
Not Found
No
The summary describes a physical dental implant system and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is a dental implant system used to support prosthetic devices for restoring mastication, which falls under restorative or prosthetic applications rather than therapeutic treatment.
No
The device is a dental implant system designed to support prosthetic devices for restoring mastication. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a dental implant system made of Titanium 6AL 4V ELI Gt.23 alloy intended to be surgically placed in bone, indicating it is a physical hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to support prosthetic devices for restoring mastication in patients with missing teeth. This is a surgical and mechanical function within the body.
- Device Description: The device is a dental implant system surgically placed in bone.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples from the human body (blood, urine, tissue, etc.)
- Providing information about a physiological or pathological state
- Being used for diagnosis, monitoring, or screening
The KJ Mini Implant System is a medical device, specifically a dental implant, used for a therapeutic purpose (restoring function) through surgical intervention.
N/A
Intended Use / Indications for Use
The KJ Mini Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 2.0mm, 2.5mm, and 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The KJ Mini Implant System is intended for single use only. It is for delayed loading.
Product codes
DZE, NHA
Device Description
KJ Mini Implant System is a dental implant system made of Titanium 6AL 4V ELI Gt.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. 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 fixture part has been treated with R.B.M. The KJ Mini Implant System offers the following implants with various sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central or lateral mandibular incisors, bone of the upper or lower jaw arches
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 according to ISO 11137-1 & ISO 11137-2 for implants and according to ISO 17665-1 & ISO 17665-2 for abutments.
- Three year shelf life testing according to ASTM F1980.
- Chemical and SEM Analysis.
Key Metrics
Not Found
Predicate Device(s)
K133050, K083067, K061319, K103194, K050970, K072959
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2016
KJ Meditech Co., Ltd. c/o Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton. California 92831
Re: K151970
Trade/Device Name: KJ Mini Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: September 22, 2016 Received: September 22, 2016
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 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
1
the quality systems (OS) 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 yours,
Michael J. Ryan -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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
KJ Mini Implant Sy stem
Indications for Use (Describe)
The KJ Mini Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 2.0mm, 2.5mm, and 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The KJ Mini Implant System is intended for single use only. It is 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
3
510(k) Summary
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 10/20/2016
1. Applicant / Submitter
| Submitter | |
|---|---|
| Name | KJ Meditech Co., Ltd. |
| Address | 959-21 Daechon-dong, Buk-gu,Gwang-ju, 500-470, |
| South Korea | |
| 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. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: KJ Mini Implant System
- . Common Name: Dental Implant System
- Classification Name: Endosseous Dental Implant
- Product Code: DZE, NHA
- Classification regulation: 21CFR872.3640
4. Predicate Device:
- Primary Predicate Device: One Plus Implant System by OsseoFuse Co., Ltd. (K133050)
- . Reference Predicate Device: MS System by OSSTEM Implant Co., Ltd. (K083067)
4
Spectra System by Implant Direct LLC (K061319) Intra-Lock Dental Implant System with Blossom by Intra-Lock International Inc. (K103194) MILO Dental Implant System by Intra-Lock International Inc. (K050970) MS System(Denture) by OSSTEM Implant Co., Ltd. (K072959)
5. Device Description:
KJ Mini Implant System is a dental implant system made of Titanium 6AL 4V ELI Gt.23 alloy intended to be surgically placed in the bone of the upper or lower jaw arches. 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 fixture part has been treated with R.B.M. The KJ Mini Implant System offers the following implants with various sizes.
| OneBody Implant | Post Implant | Ball Implant | |
|---|---|---|---|
| Implant | |||
| Diameters | 2.50mm, 2.80mm, | ||
| 3.00mm, 3.30mm, | |||
| 3.50mm, 3.80mm, | |||
| 4.00mm, 4.30mm, | |||
| 4.50mm, 4.80mm, | |||
| 5.00mm, 5.30mm | 3.50mm, 4.00mm, | ||
| 4.50mm, 5.00mm | 2.00mm, 2.50mm, | ||
| 3.00mm, 3.50mm, | |||
| 4.00mm, 4.50mm, | |||
| 5.00mm | |||
| Implant | |||
| Lengths | • (for 2.50mm-3.00mm | ||
| Dia.) 10mm, 11mm, | |||
| 12mm, 13mm, 14mm, | |||
| 15mm | |||
| • (for 3.30mm to | |||
| 5.30mm Dia.) 10mm, | |||
| 11mm, 12mm, 13mm, | |||
| 14mm,15mm, 16mm | 10mm, 11mm, 12mm, | ||
| 13mm, 14mm, 15mm, | |||
| 16 mm | • (for 2mm to 3mm): | ||
| 10mm, | |||
| 11mm, 12mm, 13mm, | |||
| 14mm, 15mm | |||
| • (for 3.5mm to 5mm): | |||
| 10mm, 11mm, | |||
| 12mm, | |||
| 13mm, 14mm, 15mm, | |||
| 16mm |
Post Abutment is offered for Post Implant and it offers straight type only. Ball Attachment is offered for Ball Implant. Both Post Abutment and Ball Attachments are made of Ti 6Al 4V ELI, Gr.23.
All the implant types of the KJ Mini Implant System are straight only.
6. Indication for use:
The KJ Mini Implant System is intended to use in the treatment of missing teeth to support prosthetic device, such as artificial teeth, in order to restore mastication in partially edentulous patients. 2.0mm, 2.5mm, and 3.0mm diameter implants are intended to be used in central or lateral mandibular incisors. The KJ Mini Implant System is intended for single use only. It is for delayed loading.
5
7. Basis for Substantial Equivalence
The KJ Mini Implant System has the same intentified predicate devices. They are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium.
The subject and predicate devices are similar in design, size, materials, and are sterilized via gamma irradiation for fixtures.
| Subject Device | Primary Predicate Device | Reference Predicate Device | Reference Predicate Device3 | |
|---|---|---|---|---|
| 510(K) Number | K151970 | K133050 | K083067 | K061319 |
| Device Name | KJ Mini Implant System | One Plus Implant System | MS System | Spectra System |
| (One Piece Implants) | ||||
| Applicant | KJ Meditech Co., Ltd. | OsseoFuse Co., Ltd. | OSSTEM Implant Co., Ltd. | Implant Direct LLC |
| Contract Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. | ||
| Indications for Use | The KJ Mini Implant System is | |||
| intended to use in the treatment | ||||
| of missing teeth to support | ||||
| prosthetic device, such as | ||||
| artificial teeth, in order to | ||||
| restore mastication in partially | ||||
| edentulous patients. 2.0mm, | ||||
| 2.5mm, and 3.0mm diameter | ||||
| implants are intended to be | ||||
| used in central or lateral | ||||
| mandibular incisors. The KJ | ||||
| Mini Implant System is | ||||
| intended for single use only. It | ||||
| is for delayed loading. | The One Plus Implant System | |||
| is intended to use in the | ||||
| treatment of missing teeth to | ||||
| support | ||||
| prosthetic device, such as | ||||
| artificial teeth, in order to | ||||
| restore mastication in partially | ||||
| edentulous patients. 3.0mm | ||||
| diameter implants are intended | ||||
| to be used in central or lateral | ||||
| mandibular incisors. The One | ||||
| Plus Implant System is | ||||
| intended for single use only. It | ||||
| is for delayed loading. | The MS System (Narrow | |||
| Ridge) is intended to use in the | ||||
| treatment of missing | ||||
| mandibular central and lateral | ||||
| incisors to support prosthetic | ||||
| device, such as artificial teeth, | ||||
| in order to restore chewing | ||||
| function in partially edentulous | ||||
| patients. MS System (Narrow | ||||
| Ridge) is intended for single | ||||
| use | ||||
| only. It is not for immediate | ||||
| loading. | The Spectra Dental Implant | |||
| System consists of one-piece or | ||||
| two-piece implants for single- | ||||
| stage or two stage surgical | ||||
| procedures that are intended for | ||||
| use in partially or fully | ||||
| edentulous mandibles and | ||||
| maxillae, in support of single or | ||||
| multiple-unit restorations and | ||||
| terminal or intermediate | ||||
| abutment support for fixed | ||||
| bridgework. They may be | ||||
| placed in immediate function if | ||||
| initial implant stability can be | ||||
| established. | ||||
| The ScrewDirect 3.0mm | ||||
| implant is indicated for: |
- An artificial root structure for
single tooth replacement of
mandibular central and lateral
incisors |
7.1. OneBody Implant
510(k) Submission.
6
| and maxillary lateral incisors. | ||||
|---|---|---|---|---|
| Technological characteristics | Implant Type: One Piece Type RBM Treatment on the fixture body Body Design: Threaded body | Implant Type: One Piece Type RBM Treatment on the fixture body Body Design: Threaded body | Implant Type: One Piece Type RBM Treatment on the fixture body Body Design: Threaded body | Threaded, root form implant Tapered threaded body with an integrated abutment Self-tapping |
| Principles of Operation | One piece type which a fixture and an abutment are integrated. | One piece type which a fixtu re and an abutment are integ rated. | One piece type which a fixtu re and an abutment are integ rated. | One piece type which a fixture and an abutment are integrated. |
| Appearance | Image: Implant | Image: Implant | Image: Implant | Image: Implant |
| Material | Ti 6A1 4V ELI, Gr.23 | Ti 6A1 4V ELI, Gr.23 | Ti 6A1 4V ELI, Gr.23 | Titanium Alloy |
| Surface Treatment | RBM Treatment on the fixture body | RBM Treatment on the fixture body | ||
| TiN coating on the abutment | RBM Treatment on the fixture body | RBM Treatment on the fixture body | ||
| Implant Sterile | Yes | Yes | Yes | Yes |
| Sterilization Method | Gamma | Gamma | Gamma | Gamma |
| Restoration type | Single unit, Multi unit | Single Unit, Multi unit | Single Unit, Multi unit | Single Unit, Multi unit |
| Implant Diameters | 2.50mm, 2.80mm, 3.00mm, | |||
| 3.30mm, 3.50mm, 3.80mm, | ||||
| 4.00mm, 4.30mm, 4.50mm, | ||||
| 4.80mm, 5.00mm, 5.30mm | 3.00mm, 3.75mm, 4.50mm, | |||
| 5.25mm | 2.50mm 3.00mm | 3.0mm, 3.7mm, 4.7mm, 5.7 mm | ||
| Implant Lengths | (for 2.50mm-3.00mm Dia.) | |||
| 10mm-15mm | 11.5mm, 13mm, 14.5mm | 10.0 mm, 13.0mm, 15.0mm | 10mm, 13mm, 16mm | |
| • (for 3.30mm to 5.30mm | ||||
| Dia.) 10mm-16mm | ||||
| Product Code | DZE | DZE | DZE | DZE |
510(k) Submission.
510(k) summary , 4 / 10 page
7
Substantial Equivalence Discussion
The subject device is substantially equivalent to the noted on tabulated device specifications and properties presented. Based on the comparison analysis, similar intended use, comparable technological characteristics, and similar general design features, the subject device is substantially equivalent to the predicate differences between the KJ Mini Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to the predicate devices in design, function, material and intended use.
7.2. Post Implant
| Subject Device | Predicate Device1 | Predicate Device2 | |
|---|---|---|---|
| 510(K) Number | K151970 | K103194 | K050970 |
| Device Name | KJ Mini Implant System | Intra-Lock Dental Implant System with | |
| Blossom | MILO Dental Implant System | ||
| Manufacturer | KJMEDITECH Co., Ltd. | Intra-Lock International Inc. | Intra-Lock International Inc. |
| Indications for Use | The KJ Mini Implant System is | ||
| intended to use in the treatment of | |||
| missing teeth to support prosthetic | |||
| device, such as artificial teeth, in | |||
| order to restore mastication in | |||
| partially edentulous patients. 2.0mm, | |||
| 2.5mm, and 3.0mm diameter | |||
| implants are intended to be used in | |||
| central or lateral mandibular incisors. | |||
| The KJ Mini Implant System is | |||
| intended for single use only. It is for | |||
| delayed loading. | The Intra-lock Dental Implant system | ||
| has been designed to restore partially | |||
| or fully edentulous patients. The | |||
| Implant have been designed to be used | |||
| in either the mandible or the maxilla | |||
| and to support removable or fixed | |||
| prosthesis from Single tooth | |||
| replacement to full arch reconstruction. | |||
| They are intended for immediate | |||
| function on single and/or multiple tooth | |||
| applications when good primary | |||
| stability is achieved, with appropriate | |||
| occlusal loading, in order to restore | MILO Implants are indicated for | ||
| long-term maxillary and mandibular | |||
| tissue-supported denture | |||
| stabilization. Multiple implants may | |||
| be restored after a period of time or | |||
| placed in immediate function. | |||
| normal teeth functions | |||
| Technological | |||
| characteristics | • Implant Type: Mini Implant Type | ||
| • Neck Design: Straight walled neck | |||
| • RBM Treatment on the fixture | |||
| body | |||
| • Body Design: Threaded body | • Implant Type: Mini Implant Type | ||
| • Neck Design: Straight walled neck | |||
| • Body Design: Threaded body | • Implant Type: Mini Implant Type | ||
| • Neck Design: Straight walled neck | |||
| • Body Design: Threaded body | |||
| Principles of | |||
| Operation | Fix the abutment to the implant by | ||
| friction | Fix the abutment to the implant by | ||
| friction | Fix the abutment to the implant by | ||
| friction | |||
| Appearance | Image: Three implants | Image: An implant | Image: Two implants |
| Material | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 |
| Surface Treatment | RBM Treatment on the fixture body | RBM Treatment on the fixture body | RBM Treatment on the fixture body |
| Implant Sterile | Yes | Yes | Yes |
| Sterilization Method | Gamma | Gamma | Gamma |
| Restoration type | Single unit, Multi unit | Single Unit, Multi unit | Single Unit, Multi unit |
| Implant Diameters | 3.50mm, 4.00mm, 4.50mm, 5.00mm | 3.4mm, 4.0mm, 6.0mm | 3.0mm |
| Implant Lengths | 10 - 16 mm | 10mm~18mm | 10mm~15mm |
510(k) Submission.
510(k) summary , 5 / 10 page
8
510(k) Submission.
510(k) summary , 6 / 10 page
9
| Abutment Appearance | 9mm | 7.3mm | |
|---|---|---|---|
| Abutment Total Leng | |||
| th | 9.0mm~9.5mm | 7.3mm ~ 10mm | 7.3mm ~ 10mm |
| Abutment Material | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 |
| Abutment Surface Tr | |||
| eatment | None | None | None |
| Abutment Type | Straight | Straight, Angled | Straight, Angled |
Substantial Equivalence Discussion
The subject device is substantially equivate to the noted predicate devices specifications and properties presented. Based on the comparison analysis, similar intended use, comparable technological characteristics, and similar general design features, the subject device is substantially equivalent to the predicate devices. There are no significant differences between the KJ Mini Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to the predicate devices in design, function, material and intended use.
10
7.3. Ball Implant
| Subject Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| 510(K) Number | K151970 | K072959 | K103194 | K050970 |
| Device Name | KJ Mini Implant System | MS System(Denture) | Intra-Lock Dental Implant | |
| System with Blossom | MILO Dental Implant System | |||
| Manufacturer | KJ Meditech Co., Ltd. | OSSTEM Implant Co., Ltd. | Intra-Lock International Inc. | Intra-Lock International Inc. |
| Indications for Use | The KJ Mini Implant System is | |||
| intended to use in the treatment | ||||
| of missing teeth to support | ||||
| prosthetic device, such as | ||||
| artificial teeth, in order to | ||||
| restore mastication in partially | ||||
| edentulous patients. 2.0mm, | ||||
| 2.5mm, and 3.0mm diameter | ||||
| implants are intended to be | ||||
| used in central or lateral | ||||
| mandibular incisors. The KJ | ||||
| Mini Implant System is | ||||
| intended for single use only. It | ||||
| is for delayed loading. | The MS System (Denture) is | |||
| intended to be place in the bone | ||||
| of the upper or lower jaw | ||||
| arches to provide support the | ||||
| prosthetic devices to restore the | ||||
| patient's | ||||
| chewing function, including the | ||||
| denture stabilization. MS | ||||
| System (Denture) is | ||||
| intended for single use only. | The Intra-lock Dental Implant | |||
| system has been designed to | ||||
| restore partially or fully | ||||
| edentulous patients. The | ||||
| Implant have been designed to | ||||
| be used in either the mandible | ||||
| or the maxilla and to support | ||||
| removable or fixed prosthesis | ||||
| from Single tooth replacement | ||||
| to full arch reconstruction. | ||||
| They are intended for | ||||
| immediate function on single | ||||
| and/or multiple tooth | ||||
| applications when good | ||||
| primary stability is achieved, | ||||
| with appropriate occlusal | ||||
| loading, in order to restore | ||||
| normal teeth functions | MILO Implants are indicated | |||
| for long-term maxillary and | ||||
| mandibular tissue-supported | ||||
| denture stabilization. Multiple | ||||
| implants may be restored after | ||||
| a period of time or placed in | ||||
| immediate function. | ||||
| Design | • Implant Type: Ball Shape | |||
| Head Implant Type | ||||
| • RBM Treatment on the | ||||
| fixture body | ||||
| • Body Design: Threaded body | • Implant Type: Ball Shape | |||
| Head Implant Type | ||||
| • RBM Treatment on the | ||||
| fixture body | ||||
| • Body Design: Threaded body | • Implant Type: Mini Implant | |||
| Type | ||||
| • Neck Design: Straight walled | ||||
| neck | ||||
| • Body Design: Threaded bo | ||||
| dy | • Implant Type: Mini Implant | |||
| Type | ||||
| • Neck Design: Straight walled | ||||
| neck | ||||
| • Body Design: Threaded body | ||||
| Principles of Operation | Ball shaped implant head | |||
| allowing for the retaining | ||||
| structures to snap over the ball | Ball shaped implant head all | |||
| owing for the retaining struct | ||||
| ures to snap over the ball | Ball shaped implant head | |||
| allowing for the retaining | ||||
| structures to snap over the ball | Ball shaped implant head | |||
| allowing for the retaining | ||||
| structures to snap over the ball |
510(k) Submission.
11
| Appearance | Image: Implant | Image: Implant | Image: Implant | Image: Implant |
|---|---|---|---|---|
| Material | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 | Ti 6Al 4V ELI, Gr.23 |
| Surface Treatment | RBM Treatment on the fixture | |||
| body | RBM Treatment on the fixture | |||
| body | RBM Treatment on the fixture | |||
| body | RBM Treatment on the fixture | |||
| body | ||||
| Implant Sterile | Yes | Yes | Yes | Yes |
| Sterilization Method | Gamma | Gamma | Gamma | Gamma |
| Restoration type | Overdenture | Overdenture | Overdenture | Overdenture |
| Implant Diameters | 2.00mm, 2.50mm, 3.00mm, | |||
| 3.50mm, 4.00mm, 4.50mm, | ||||
| 5.00mm | 2.00mm 3.00mm | 3.4mm, 4.0mm, 6.0mm | 3.0mm | |
| Implant Lengths | (for 2mm to 3mm): 10- | |||
| 15mm | ||||
| (for 3.5mm to 5mm): 10- | ||||
| 16mm | 10.0 mm, 13.0mm, 15.0mm | 10mm~18mm | 10mm~15mm | |
| Attachment | Image: Attachment | Image: Attachment | Image: Attachment | Image: Attachment |
Substantial Equivalence Discussion
The subject device is substantially equivate devices based on tabulated device specifications and properties presented. Based on the comparison analysis, similar intended use, comparable technological characteristics, and similar general design features, the subject device is substantially equivalent to the predicate differences between the KJ Mini Implant System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to the predicate devices in design, function, material and intended use.
510(k) Submission.
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8. Non-Clinical Testing
- Sterilization validating testing ●
- o according to ISO 11137-1 & ISO 11137-2 for implants
- o according to ISO 17665-1 & ISO 17665-2 for abutments
- Three year shelf life testing according to ASTM F1980
- Chemical and SEM Analysis
9. Conclusion
The subject devices and the predicate device have the same intended use and have the same technological characteristics.
Overall, the KJ Mini Implant System has the following similarities to the predicate device:
-
- have the same intended use,
-
- use the same operating principle,
-
- incorporate the same basic design,
-
- incorporate the same material and the surface treatment
Based on the similarities, we conclude that the KJ Mini Implant System is substantially equivalent to the predicate devices.