(146 days)
Not Found
No
The summary describes a mechanical dental implant system and does not mention any software, algorithms, or AI/ML capabilities.
No
The device provides temporary support for a prosthetic device during healing and does not itself treat a condition or provide therapy. Its function is to support a prosthetic, which in turn helps patients during the healing phase, but it's not directly therapeutic in itself.
No
Explanation: The device is a mini implant system intended to provide temporary support for a provisional prosthetic device during the healing phase of permanent dental implants. Its purpose is mechanical support, not to diagnose a condition or disease.
No
The device description clearly states it is a "mini implant system" made of CP Titanium, indicating it is a physical hardware device, 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.
- Device Function: The I-FIX System is a mini implant system designed to be surgically placed in the jawbone (mandibles and maxillae) to provide temporary support for dental prosthetics. It is a physical device used in vivo (within the body), not a test performed in vitro (outside the body).
- Intended Use: The intended use clearly states it serves as "temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants." This is a structural and mechanical function within the body.
Therefore, the I-FIX System falls under the category of a medical device, specifically a dental implant system, rather than an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The I-FIX System are intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
The I-FIX System is mini implant system, which serves temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. The I-FIX System is comprised in diameter of 2.0 - 3.0mm and range from 10 - 16 mm and is made of CP Titanium grade 4. The surface treatment of I-Fix System is of R.B.M (Resorbable Blasting Media).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
partially or fully edentulous manidibles 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)
mechanical testing of the implants demonstrated that the I-Fix System possess mechanical strength at least equivalent to the predicate devices.
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
1-Fix System 510(K) Submission
Dentis Co., Ltd.
APR 9 9 2009
1 87 2
510(K) Summary
Submitter
Dentis Co., Ltd. Shim Gi Bong #951, Woram-Dong, Dalseo-Gu, Daegu, South Korea Phone: 82-53-589-3530 Fax: 82-53-583-2806 Registration Number: 3007031098
Device Information
Product Name: I-Fix System
Common Name: Endosseous Dental Implant
Classification Name: Implant, Endosseous, Root-Form
Product Code: DZE
Regulation Number: 872.3640
Device Class: Class II
General Description
The I-FIX System is mini implant system, which serves temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants. The I-FIX System is comprised in diameter of 2.0 - 3.0mm and range from 10 - 16 mm and is made of CP Titanium grade 4. The surface treatment of I-Fix System is of R.B.M (Resorbable Blasting Media).
Indication for Use
The I-FIX System are intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
Official Correspondent Kodent Inc. Jung Bae Bang 13340 E. Firestone Blvd. Suite J Santa Fe Springs, CA 90670 Email: kodentinc@kodent.co.kr
Phone: 562-404-8466
Fax: 562-404-2757
48
1
2872
Materials
イ
This device are manufactured from TI6A1-4V ELI alloy following ASTM and ISO standards.
Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
- . Intermezzo™ Implant System (K051018) manufactured by Megagen Implant Co., Ltd.
Comparison to Predicate Devices
Testing and other comparisons have established that the subject of I-Fix System is substantially equivalent in design, materials, indications and intended use, packaging, labeling, and performance to other predicate devices of the type currently marketed in the U.S.
Performance Data
All of the data consistent with the recommendations in the FDA guidance document Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, May 12, 2004, mechanical testing of the implants demonstrated that the I-Fix System possess mechanical strength at least equivalent to the predicate devices.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR & 807.93
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, on the right side. On the left side of the seal, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern. The seal is presented in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Dentis Company, Limited C/o Mr. Jung Bae Bang Kodent, Incorporated 13340 East Firestone Boulevard Suite J Santa Fe Springs, California 90670
APR 2 9 2009
Re: K083586
Trade/Device Name: I-Fix System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 13, 2009 Received: April 13, 2009
Dear Mr. Bang:
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 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.
3
Page 2- Mr. Bang
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Susan Runner
Susan Runner, D.D.S., MA Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Dentis Co., Ltd.
1000
Indication for Use
510(K) Number (if known):
Device Name: I-Fix System
Indication for Use:
The I-FIX System are intended to load immediately in partially or fully edentulous manidibles and maxillae to serve as temporary support for provisional prosthetic device during the healing phase of permanent endosseous dental implants.
Prescription Use X
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter
(Per 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)
Page 1 of 1
| sion of Anesthesiology, General Hospital |
|---|
| fection Control, Dental Devices |
| 10(k) Number: | K083586 |
|---|---|
| --------------- | --------- |
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