(194 days)
Not Found
No
The description focuses on the material, geometry, and intended use of a dental implant system, with no mention of AI or ML technology.
Yes
The device is intended to restore a patient's chewing function by providing support for a prosthetic device, which aligns with the definition of a therapeutic device as it treats a condition (loss of chewing function).
No
The device is described as an implant system to support a prosthetic device and restore chewing function, not to diagnose a condition.
No
The device description clearly states it is a titanium alloy screw-type endosseous dental implant and abutment, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The JNE Implant System is a physical implant and abutment surgically placed within the body (in the jawbone). It is a prosthetic device designed to restore chewing function.
- Intended Use: The intended use is to provide support for a prosthetic device in the body.
The description clearly indicates a surgically implanted device, not a device used to test samples outside the body.
N/A
Intended Use / Indications for Use
The JNE Implant System is a titanium alloy screw-type endosseous dental implant and endosseous dental implant abutment, which is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function.
Product codes
DZE, NHA
Device Description
The JNE Implant System is an endosseous dental implant made of Ti-6Al-4V ELI alloy and consists of several components. Geometrically, the fixture is screw-type. An abutment is connected to the fixture through a tapered-joint. Fixtures are treated with sandblast and acid etching using scanning electron microscopy (SEM).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Several tests were performed on the device. All tests demonstrated that the device is safe and effective, performs comparably to and is substantially equivalent to the predicate devices.
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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MAR 1 0 2008
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| Regulation: 21 CFR 872.3640 and 21 CFR 872.3630 | |
|---|---|
| Identification of | |
| Predicates and Summary | |
| of Substantial | |
| Equivalence | The JNE Implant System is substantially equivalent with |
| respect to the intended use, design, risks, device | |
| characteristics and performance aspects to numerous cleared | |
| devices, including: | |
| 510(k) / Product / Manufacturer |
- K971196 / ENDOPORE ENDOSSEOUS DENTAL
IMPLANT SYSTEM / INNOVA CORP. - K002513 / ASTRA TECH IMPLANTS - DENTAL
SYSTEM / ASTRA TECH, INC. |
| | - K033984 / STRAUMANN DENTAL IMPLANT
SYSTEM / INSTITUT STRAUMANN AG |
| Device Description | The JNE Implant System is an endosseous dental implant
made of Ti-6Al-4V ELI alloy and consists of several
components. Geometrically, the fixture is screw-type. An
abutment is connected to the fixture through a tapered-joint.
Fixtures are treated with sandblast and acid etching using
scanning electron microscopy (SEM). |
| Intended Use and
Indications | The JNE Implant System is a titanium alloy screw-type
endosseous dental implant and endosseous dental implant
abutment, which is intended to be surgically placed in the
bone of the upper or lower jaw arches to provide support for a
prosthetic device, such as an artificial tooth, in order to restore
a patient's chewing function. |
| Performance Testing | Several tests were performed on the device. All tests
demonstrated that the device is safe and effective, performs
comparably to and is substantially equivalent to the predicate
devices. |
- 510(k) Summary
:
Page 5.2 of 5.2
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5. 510(k) Summary
| Submitter/Contact
Person | H. Carl Jenkins
The Wood Burditt Group
FDA Regulatory Counseling
1025 W. Everett Rd., Suite 100
Lake Forest, IL 60045
(ph) (847) 234-7500 x 205
(fax) (847) 574-0728
(email) hcjenkins@woodburditt.com |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | GC America, Inc.
3737 W. 127th Street
Alsip, IL 60803
800.323.3386 x4042
708.897.4042
708.897.4031 (fax) |
| Manufacturer | GC CORPORATION.
76 - 1 HASUNUMA - CHO,
ITABASHI - KU
TOKYO 174 - 8585 JAPAN |
| Sterilization Facility | RADIA INDUSTRY CO., LTD
168 OOYAGI, TAKASAKI
GUNNMA 370 - 0072 JAPAN |
| Device Name | JNE Implant System |
| Common Name | Root-form Endosseous Dental Implant and Endosseous
Dental Implant Abutment |
| Classification | Class II
Procode DZE and NHA |
- 510(k) Summary
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GC America, Incorporated C/O Mr. H. Carl Jenkins The Wood Burditt Group 1025 Everett Road, Suite 100 Lake Forest, Illinois 60045
MAR 1 0 2008
Re: K072425
Trade/Device Name: GC JNE Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 28, 2008 Received: January 29, 2008
Dear Mr. Jenkins:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Jenkins
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sydite Y. Michien Omd.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: GC JNE Implant
Indications for Use:
The JNE Implant System is a titanium alloy screw-type endosseous dental implant and endosseous dental implant abutment, which is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for a prosthetic device, such as an artificial tooth, in order to restore a patient's chewing function.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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) |
|---|
| -------------------------------------------------------- |
Susan Turner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
- Indications For Use
Page 4.1 of 4.1
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