(79 days)
No
The summary describes a standard dental implant system made of titanium alloy with a treated surface. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on physical design changes and equivalence to a predicate device.
Yes
The device is a dental implant system used to replace missing teeth, which directly provides a therapeutic effect by restoring oral function and aesthetics.
No
The provided text describes a dental implant system intended for surgical placement to support restorations. There is no mention of the device being used to diagnose 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, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the I2A and I2C Dental Implant Systems are surgically placed in the bone of the jaw. This is an invasive procedure performed directly on the patient's body, not on a sample taken from the body.
- Intended Use: The intended use is to support dental restorations in edentulous areas of the jaw. This is a structural and functional purpose within the body, not a diagnostic test performed on a sample.
Therefore, the device described is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The I2A Dental Implant System and I2C Dental Implant System are 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 12A Dental Implant System and J2C Dental 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 J2A Dental Implant System and J2C Dental Implant System are 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 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 these systems have been treated with R.B.M (Resorbable Blast Media).
The J2A Dental Implant System comes in diameters of 3.75mm, 4.00mm, 4.30mm, 4.50mm, 5.00mm, 5.50mm, and 6.00mm, with lengths ranging from 7mm to 15mm.
The J2C Dental Implant System comes in diameters of 3.75mm, 4.00mm, 4.30mm, 4.50mm, 5.00mm, 5.50mm, and 6.00mm, with lengths ranging from 7mm to 15mm.
There are one-piece and two-piece abutments compatible with both J2A and J2C fixtures, made of Ti 6Al 4V ELI, ASTM F136 with TiN Coating. Dimensions for abutments include diameters Ø4mm ~ Ø7mm, cuff 1mm5mm, and height 4.0mm7.0mm. Connection platforms are Narrow platform & Wide platform.
Cover screws made of Titanium 6AL 4V ELI alloy are also provided for both J2A and J2C fixtures.
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)
Risk analysis was conducted according to ISO14971 to demonstrate that the following modifications to the company's own predicate, Hero II Dental Implant System (K121047) is substantially equivalent:
- Fixture thread design change
- Fixture size addition
- Coating area expansion for one-piece type abutments
- Abutment size addition
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.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around the perimeter. At the center of the seal is a stylized representation of a human figure, composed of three overlapping profiles facing to the right. The seal is rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2015
KJ Meditech Co., Ltd. C/O Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831
Re: K150060
Trade/Device Name: J2A Dental Implant System, J2C Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: March 02, 2015 Received: March 06, 2015
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.
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 (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/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 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,
Tina
Kiang -S
for 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name J2A Dental Implant System, J2C Dental Implant System
Indications for Use (Describe)
The I2A Dental Implant System and I2C Dental Implant System are 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 12A Dental Implant System and J2C Dental Implant System are 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)
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)
3
510(k) Summary (K150060)
This summary of 510(K) – substantial equivalence information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 04/02/2015
1. 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: J2A Dental Implant System
- J2C Dental 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: HERO II Dental Implant System by KJ Meditech Co., Ltd. (K121047)
- . Reference Predicate Devices: TS Fixture System by OSSTEM IMPLANT CO.,LTD (K121995) GS III SYSTEM by OSSTEM IMPLANT CO.,LTD (K091208)
4
5. Description:
The J2A Dental Implant System and J2C Dental Implant System are 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 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 these systems have been treated with R.B.M (Resorbable Blast Media). The size information is as below.
J2A Dental Implant System
- · 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)
J2C Dental Implant System
- 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) / 11.5mm(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)
There are one-piece abutments which are compatible with both J2A and J2C fixtures with the following features. Only straight abutments are provided.
| Material / Surface Treatment | Ti 6Al 4V ELI, ASTM F136 / TiN Coating |
|---|---|
| Dimensions | Diameter: Ø4mm ~ Ø7mm Cuff: 1mm |
There are also two-piece abutments which are compatible with both J2A and J2C fixtures with the following features. Only straight abutments are provided.
| Material / Surface Treatment | Ti 6Al 4V ELI, ASTM F136 / TiN Coating |
|---|---|
| Dimensions | • Diameter: Ø4mm ~ Ø7mm |
| • Cuff: 1mm~5mm | |
| • Height: 4.0mm~7.0mm | |
| • Connection platform: Narrow platform & Wide platform | |
| Cover screws made of Titanium 6Al 4V ELI alloy are also provided both for I2A and I2C |
Cover screws made of Titanium 6AL 4V ELI alloy are also provided both for J2A and J2C fixtures.
5
6. Indication for use:
The J2A Dental Implant System and 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 and J2C Dental Implant System are for single and two stage surgical procedures. These systems are intended for delayed loading.
6
7. Basis for Substantial Equivalence
7.1. Fixtures and Cover Screws
The I2A Dental Implant and J2C Dental Implant have the identified predicate devices. They 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 internal hexagon abutment connection system with interface. The subject and predicate devices are both bone-level implants that share similar body shape design walled neck and tapered body design.
The manufacturing facility, raw materials for the surface treatments (RBA treatment), surface treatment method, manufacturing process, and cleaning process of the J2A and I2C Dental Implant are identical to the predicate device (Hero I and IS Dental Implant System, K121047).
| Item | Subject Device
(Modified Device 1) | Subject Device
(Modified Device 2) | Primary Predicate
Device
(Unmodified Device) | Reference Predicate
Device 1 | Reference Predicate Device 2 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K150060 | K150060 | K121047 | K121995 | K091208 |
| Device Name | J2A Dental Implant
System | J2C Dental Implant
System | HERO II Dental
Implant System | TS Fixture System | GS III SYSTEM |
| Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. | OSSTEM IMPLANT
CO.,LTD | OSSTEM IMPLANT
CO.,LTD |
| Indications for
Use | The J2A 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, | The J2C 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 | The HERO II 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, | The TS Fixture 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, | The GS III System is indicated
for use in partially or fuhlly
edentulous mandibles and
maxillae, in support of single
or multiple-unit restorations
including; cemented retained,
screw retained, or overdent-
ure restorations, and terminal
or intermediate abutment
support for fixed bridgework. |
| | screw retained, or
overdenture
restorations, and
terminal or
intermediate abutment
support for fixed
bridgework. The J2A
Dental Implant System
is for single and two
stage surgical
procedures. The system
is intended for delayed
loading. | overdenture
restorations, and
terminal or
intermediate abutment
support for fixed
bridgework. The J2C
Dental Implant System
is for single and two
stage surgical
procedures. The system
is intended for delayed
loading. | screw retained, or
overdenture
restorations, and
terminal or
intermediate abutment
support for fixed
bridgework. The HERO
II Dental Implant
System is for single and
two stage surgical
procedures. The system
is intended for delayed
loading. | and final or temporary
abutment support for
fixed bridgework. It is
intended for delayed
loading.
TS Fixture System is
compatible with
abutment in the ET/SS
Implant
System. | The GS II System is for single
and two stage surgical
procedures.
It is not for immediate load. |
| 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
| • 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
• 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 |
| Appearance | Image: Implant 1 | Image: Implant 2 | Image: Implant 3 | Image: Implant 4 | Image: Implant 5 |
| Endosseous
Implant Material | Ti 6Al 4V ELI, ASTM
F136 | Ti 6Al 4V ELI, ASTM
F136 | Ti 6Al 4V ELI, ASTM
F136 | Grade 4 Pure Titanium
(ASTM F67) | Grade 4 Pure Titanium
(ASTM F67) |
| Surface
Treatment | RBM Treatment | RBM Treatment | RBM Treatment | SA Treatment | SA Treatment |
| Sterilization
Method | Same - No
modification | Same - No
modification | Gamma | Gamma | Gamma |
| 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 | 3.75mm, 4.0mm,
4.5mm, 5.0 mm,
6.0mm | 3.75mm, 3.77mm,
4.2mm, 4.25mm,
4.6mm, 4.63mm,
4.65mm, 5.05mm,
5.08mm, 5.1mm | 3.75mm~5.1mm |
| Implant Lengths | 7.0mm - 15.0 mm | 7.0mm - 15.0 mm | 8.5mm - 15.0 mm | 7.0mm - 15.0 mm | 7.0 - 15.0 mm |
| Cover Screw | Image: Ti 6Al 4V ELI, ASTM F136 | Image: Ti 6Al 4V ELI, ASTM F136 | Image: Ti 6Al 4V ELI, ASTM F136 | Image: Ti 6Al 4V ELI, ASTM F136/Anodizing | - |
510(k) Submission.
510(k) summary , 4 / 9 page
7
510(k) Submission.
510(k) summary , 5 / 9 page
8
7.2. Abutments
The I2A and J2C Abutments have the same intentified predicate devices. They are similar in fundamental scientific technology and design. The subject and the predicate devices offer one-piece as well as two-piece type abutments.
The manufacturing facility, raw materials for the surface treatments (TiN coating), surface treatment method, manufacturing process, and cleaning process of the J2A and J2C Abutments are identical to the predicate device (Hero I and IS Dental Implant System, K121047).
| Item | Subject Device
(Modified Device) | Primary Predicate Device
(Unmodified Device) | Reference Predicate Device |
|---------------|-------------------------------------|-------------------------------------------------|----------------------------|
| 510(K) Number | K150060 | K121047 | K121995 |
| Device Name | J2A and J2C Dental Implant System | HERO II Dental Implant System | TS Fixture System |
510(k) Submission.
9
| Manufacturer | KJ Meditech Co., Ltd. | KJ Meditech Co., Ltd. | OSSTEM IMPLANT CO.,LTD |
|---|---|---|---|
| Indications for | |||
| Use | The J2A and J2C Dental Implant | ||
| Systems 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 and J2C Dental Implant | |||
| Systems are for single and two stage | |||
| surgical procedures. The system is | |||
| intended for delayed loading. | The HERO II 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 HERO II Dental | |||
| Implant System is for single and two | |||
| stage surgical procedures. The system | |||
| is intended for delayed loading. | The TS Fixture 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 final | |||
| or temporary abutment support for | |||
| fixed bridgework. It is intended for | |||
| delayed loading. | |||
| TS Fixture System is compatible | |||
| with abutment in the ET/SS Implant | |||
| System. | |||
| One Piece | |||
| Abutment | • Ti 6Al 4V ELI, ASTM F136 / | ||
| TiN Coating (Entire body) | |||
| • Diameter: Ø4mm ~ Ø7mm | |||
| Cuff: 1mm~5mm | |||
| Height: 4.0mm~7.0mm | • Ti 6Al 4V ELI, ASTM F136 / TiN | ||
| Coating (Partial) | |||
| • Diameter: Ø4mm ~ Ø6mm | |||
| Cuff: 1mm~4mm | |||
| Height: 4.0mm~7.0mm | • Ti 6Al 4V ELI, ASTM F136 / | ||
| TiN Coating (Partial) | |||
| • Diameter: Ø4mm ~ Ø7mm | |||
| Cuff: 1mm~5mm | |||
| Height: 4.0mm~7.0mm |
10
| Two Piece
Abutment | Image: Dental abutment and screw
Ti 6Al 4V ELI, ASTM F136 /
TiN Coating (Entire body) Diameter: Ø4mm ~ Ø7mm Cuff: 1mm5mm Height: 4.0mm7.0mm | Image: Dental abutment and screw
Ti 6Al 4V ELI, ASTM F136 / TiN
Coating (Entire body) Diameter: Ø4mm ~ Ø7mm Cuff: 1mm4mm Height: 4.0mm7.0mm | Image: Dental abutment and screw
Ti 6Al 4V ELI, ASTM F136 /
TiN Coating (Entire body) Diameter: Ø4mm ~ Ø7mm Cuff: 1mm5mm Height: 4.0mm7.0mm |
| ----------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
11
8. Non-Clinical Testing
Risk analysis was conducted according to ISO14971 to demonstrate that the following modifications to the company's own predicate, Hero II Dental Implant System (K121047) is substantially equivalent:
- Fixture thread design change ●
- . Fixture size addition
- Coating area expansion for one-piece type abutments
- Abutment size addition .
Additional predicate devices of similar design and dimensions were identified to determine substantial equivalence. In addition, based on the risk analysis the shelf-life, sterilization, biocompatibility, and performance testing of the predicate, Hero II Dental Implant System (K121047), is applicable to the subject device.
9. Conclusion
The subject devices and the predicate device have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium and have the same surface treatments.
Overall, the J2A Dental Implant system and the J2C Dental Implant system have the following similarities to the predicate device:
-
- have the same intended use,
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- use the same operating principle,
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- incorporate the same basic design,
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- incorporate the same material and the surface treatment.
Based on the similarities, we conclude that the J2A Dental Implant system and the J2C Dental Implant system are substantially equivalent to the predicate devices.