(281 days)
Not Found
No
The summary describes a standard dental implant system and does not mention any AI or ML components, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is a dental implant system, surgically placed to support prosthetic devices and restore chewing function. This directly serves to treat a condition (edentulism) and improve patient health and function, classifying it as a therapeutic device.
No
Explanation: The provided text describes the device, ONEPLANT, as a dental implant system designed for use in dental implant surgery to support prosthetic devices. Its function is to provide physical support for artificial teeth and restore chewing function, not to diagnose medical conditions or diseases.
No
The device description explicitly states that the dental implant system consists of hardware components: Fixture, Abutment, and Implant surgical instruments.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use in "dental implant Surgery" to support "single or multiple-unit restorations" in the mouth. This is a surgical device used in vivo (within the body).
- Device Description: The description confirms it's a "surgically placed" device made of materials like titanium, intended to be placed in the jawbone.
- 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 screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework.
Product codes
DZE, NHA
Device Description
Dental implant systems are devices made of a material such as titanium 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, and to restore the patients chewing function. Dental implant system consists of Fixture, Abutment and Implant surgical instruments.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles and maxillae; 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K070228, K052957, K060501, K052823, K041368, K051576
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
RYC
MAR 2 7 2009
510(K) Summary K08 WARANTEC Co., Ltd. 307, Sunil Technopia, #440, Sangdaewon-dong, Jungwon-gu, Sungnam-si, Gyeonggi-do, 462-726, Korea TEL. +82-31-777-3026~8 FAX. +82-31-777-3025 Contact: Song, Chung-Hun/ President Date prepared: June 10, 2008
307, Sunil Technopia, #440, Sangdaewon-dong,
Jungwon-gu, Sungnam-si,
Gyeonggi-do, 462-726, Korea
TEL. +82-31-777-3026~8
FAX. +82-31-777-3025
Contact: Song, Chung-Hun/ President
Date prepared: June 10, 2008
- Trade Name: ONEPLANT Dental Implant System
-
- Common Name: Dental Implant
-
- Classification Name and Device Class: implant, endosseous, root-form DZE and Abutment, implant, dental, endosseous NHA; Class II per regulations 872.3640 and 872.3630
-
- Dental implant systems are devices made of a material such as Description of device: titanium 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, and to restore the patients chewing function. Dental implant system consists of Fixture, Abutment and Implant surgical instruments.
-
- Indications for use: ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework.
-
- Comparison Table: Below.
1
2 d 2
| Manufacturer/510(k)
Number | DENTIUM
Multiple: K070228;
K052957; K060501;
K052823; K041368 | Osstem Implant
K051576 | WARANTEC | |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Website | www.implantium.com | www.osstem.com | www.oneplant.co.kr | |
| Type name | IMPLANTIUM | GS System | ONEPLANT | |
| Intended use | It is to provide support for
prosthetic device, such as
artificial teeth, and to
restore the patient's
chewing function | GS 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. GS System is
for one stage surgical
procedures. It is not
intended for immediate
load. | ONEPLANT is designed
for use in dental implant
Surgery. These are
intended for use in
partially or fully
edentulous mandibles and
maxillae to support for
single or multiple-unit
restorations such as
cemented retained, screw
retained, or over denture
restorations and terminal
or intermediate abutment
support for fixed
bridgework. | |
| Design | Internal Connection
Morse Taper,
Internal Octagon | Internal Connection
Morse Taper,
Internal Octagon | Internal Connection
Morse Taper,
Internal Octagon | |
| Fixture | Material | Titanium G4 | Titanium G4 | Titanium G4 |
| | Platform
Dia. | 3.6, 4.0, 4.5, 5.0, 5.5mm | 3.5, 4.0, 4.5, 5.0mm | 3.3, 3.6, 4.3, 5.3mm |
| | Length | 8, 10, 12, 14mm | 7, 8.5, 10, 11.5, 13, 15mm | 8.5, 10, 11.5, 13, 15mm |
| Abutment | Material | Titanium G5 | Titanium G5 | Titanium G5 |
| | Type | Various | Various | Various |
| Certification | KGMP, CE, FDA 510k | KGMP, CE, FDA 510k | KGMP | |
-
- Conclusion: In all respects, the Oneplant Dental Implant components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products on the table above.
:
- Conclusion: In all respects, the Oneplant Dental Implant components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products on the table 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 human figure with three arms, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA", which is arranged in a circular fashion.
Public Health Service
MAR 2 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Warantec Company, Limited C/o Mr. Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield. Illinois 60015
Re: K081748
Trade/Device Name: Oneplant Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: March 16, 2009 Received: March 19, 2009
Dear Mr. Kamm:
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 - Mr. Kamm
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 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.
Sugette Y. Michie Dues
Ginette Y. Michaud, M.D. Acting 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: Oneplant Dental Implant System
Indications For Use:
ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework..
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 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
Susan Moore
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K081744
Page 15 of 740