(104 days)
Not Found
No
The description focuses on the physical characteristics and materials of a dental implant system, with no mention of AI or ML technology.
Yes
The device is described as artificially providing a root structure to support prosthetic devices to restore chewing function, which is a therapeutic purpose.
No
Explanation: The device is described as a system of dental implants and accessories used to provide a root structure for prosthetic devices, restoring chewing function. Its purpose is structural and restorative, not to detect, diagnose, monitor, or treat a disease or condition.
No
The device description explicitly states that the system consists of physical components like titanium implants, abutments, and screws, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for surgical implantation in the jaw to support prosthetic devices and restore chewing function. This is a direct medical intervention on the patient's body.
- Device Description: The description details a physical implant made of titanium, designed to be surgically placed.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is surgically implanted inside the body.
N/A
Intended Use / Indications for Use
The Inventus Implant System is a series of titanium endosseous dental implants and accessories for surgical implantation in the upper and/or lower jaw. It is intended to artificially provide a root structure to support prosthetic devices, such as artificial teeth, in order to restore the chewing function of the patient.
Product codes
DZE, NHA
Device Description
The Inventus Implant System consists of a series of root-form endosseous dental fixtures (implant) and accessories designed to support single or multiple restorations. The implants and abutments are manufactured from titanium, conforming to ASTM F67, and the screws are manufactured from titanium alloy, conforming to ASTM F136. The implants are available in @3.3mm, @3.75mm, Φ4.0mm, Φ5.5mm and Φ6.0mm diameters and vary in length from 9.0mm to 18.3mm. For optimal osseointegration, the implant surfaces are treated with resorbable blast media (RBM) incorporating hydroxylapatite (HA) powder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper and/or lower jaw
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
KO815 79
Inventus Co., Ltd. Traditional 510(k)
SEP 1 7 2008
Inventus Implant System
510(k) Summary of Safety and Effectiveness
| Manufacture Name: | Inventus Co., Ltd. |
|---|---|
| Contact Name: | Jeong-Nam Kim |
| Postal Address: | 270-13 Dodang-dong, Wonmi-gu, |
| Bucheon -si, Gyeonggi-do, Korea | |
| Phone Number: | 82-32-676-2813 |
| Fax: | 82-32-676-2816 |
| Contact: | Jeong-Kim Nam |
| Title: | General Manager |
| Date: | May 19, 2008 |
| Device Proprietary Name: | Inventus Implant System |
| Device Common or Usual Name: | Dental Implant System |
| Classification Name: | Endosseous Dental Implants |
| Classification Code | DZE, |
| NHA | |
| Classification Panel | Dental Products |
| Regulation Number | 872.3640, |
| 872.3630 |
Predicate Device:
Substantial equivalence is claimed to the following devices as related to intended use and design characteristics:
- . The Maestro™ System, BioHorizons Implant Systems, Inc., K010458
- US System, Osstem Implant Co., Ltd., K062030 .
Description of the Device
The Inventus Implant System consists of a series of root-form endosseous dental fixtures (implants) and accessories designed to support single or multiple restorations.
The implants and abutments are manufactured from titanium, conforming to ASTM F67, and the screws are manufactured from titanium alloy, conforming to ASTM F136. The implants are available in @3.3mm, @3.75mm, Φ4.0mm, Φ5.5mm and Φ6.0mm diameters and vary in length from 9.0mm to 18.3mm. For optimal osseointegration, the implant surfaces are treated with resorbable blast media (RBM) incorporating hydroxylapatite (HA) powder.
1
Intended Use of the Device
The Inventus Implant System is a series of titanium endosseous dental implants and accessories for surgical implantation in the upper and/or lower jaw. It is intended to artificially provide a root structure to support prosthetics devices, such as artificial tecth, in order to restore the chewing function of the patient.
Substantial Equivalence
The Inventus Implant System is similar to other legally marketed devices based on the intended use, design, technology, material composition and performance.
Conclusion
Based on the information provided in this 510(k) premarket notification, the Inventus Implant System is substantially equivalent in terms of safety and effectiveness to the predicate devices identified above.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the logo.
Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850
SEP 1 7 2008
Inventus Company, Limited C/o Ms. Roshana Ahmed Senior Regulatory Affairs Associate Canreg, Incorporated 4 Innovation Drive Dundas, Ontario CANADA L9H 7P3
Re: K081579
Trade/Device Name: Inventus Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: August 26, 2008 Received: August 26, 2008
Dear Ms. Ahmed:
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.
3
Page 2 - Ms. Ahmed
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 (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.
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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
MHAmult Kudimy
for 11
Chiu S. Lin. Ph. D Division Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Inventus Co., Ltd. Traditional 510(k)
Indications for Use
510(k) Number:
Device Name:
Inventus Implant System
Indication for Use:
The Inventus Implant System is a series of titanium endosseous dental implants and accessories for surgical implantation in the upper and/or lower jaw. It is intended to artificially provide a root structure to support prosthetic devices, such as artificial teeth, in order to restore the chewing function of the patient.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 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 Suarez
Division Sign-Off Office of Device Evaluation
510(k) K081579