(292 days)
Not Found
No
The summary describes a physical dental implant made of ceramic material. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
Explanation: This device is a dental implant used to replace missing teeth, which is a restorative rather than therapeutic function. It does not treat or cure a disease or condition.
No
The device description indicates that Zibone dental implants are used to "replace missing teeth" and "support prosthetic devices," which are therapeutic functions, not diagnostic ones. There is no mention of the device being used to identify or analyze a condition.
No
The device description clearly states it is a physical dental implant made of ceramic material, not software.
No, 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. These tests are performed outside of the body.
- Device Description: The description clearly states that the Zibone dental implants are "threaded; root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices." They are physically implanted into the body.
- Intended Use: The intended use is for "implantation into the upper or lower jaw to replace missing teeth." This is a surgical procedure performed on the body.
The Zibone dental implant is a medical device used for surgical implantation, not for performing diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
"Zibone one-piece ceramic dental implants are indicated for implantation into the upper or lower jaw to replace missing teeth. They are indicated for (delayed or immediate) loading once primary stability has been achieved."
Product codes (comma separated list FDA assigned to the subject device)
DZE, NHA
Device Description
Zibone ® Ceramic (Zirconia) Dental Implants are threaded; root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices. The implants are manufactured from yttrium stabilized zirconium oxide bioceramics material conforming to ISO 13356-2008: Implants for surgery-ceramic materials based on yttria-stablized tetragonal ziconia (Y-TZP). The implant has a one-piece design (both implant and abutment), which simplifies the surgical procedures.
The implants are single use devices and are delivered in sterile condition have been sterilized with moisture heat. Zibone ceramic dental implants are also subjected to a sandblasting process that is used to impart the surface of the devices to enhance the osseointegration process.
Zibone dental implants are offered in three diameters (3.6mm, 4mm and 5mm) and 5 insertion lengths (8mm, 10mm, 11.5mm, 13mm and 14.5mm) for different teeth. The general rule is to select largest and longest implant size that the indication permits.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following were reviewed to support the performance of Zibone Summary of 8. Ceramic Dental Implant System: Fatigue test to ISO 14801, Nonclinical Testing: Sterilization validation, Shelf life testing, Surface analysis & Biocompatibility testing.
No Clinical studies are submitted. 9. Summary of Clinical Testing:
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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).
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§ 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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510(k) SUMMARY
JUN 0 4 2014
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92
Date of preparation: June 4, 2014
| 1. Submitter's Name: | Coho Technology Co., Ltd. |
|---|---|
| Address: | No. 21, Dafeng St., Luju Township, Taoyan County, TAIWAN |
| Phone: | +886-3-3112203 Ex.: 512 |
| Fax: | +886-3-3125626 |
| Contact: | Jacky Hsieh / Vice General Manager |
| 2. Device Name : | |
| Trade Name: | Zibone Ceramic Dental Implant System |
| Common Name: | Endosseous dental implant |
| Classification name | Implant, Endosseous, Root-Form |
| 3. Device Class: | Zibone Ceramic Dental Implant System has been classified as |
| Regulatory Class: | II |
| Product Code: | DZE |
| Panel : | Dental |
| Regulation Number: | 21CFR 872.3640 |
| 4. Predicate Device: | The predicate device is the |
| • Z-Systems AG - Z-Look3 Dental Implant System - | |
| (K062542) marketed byZ-Look3 dental implant system | |
| 5. Indications for Use | "Zibone one-piece ceramic dental implants are indicated for |
| implantation into the upper or lower jaw to replace missing teeth. | |
| They are indicated for (delayed or immediate) loading once | |
| primary stability has been achieved." | |
| 6. Device Description: | Zibone ® Ceramic (Zirconia) Dental Implants are threaded; root-form |
| dental implants intended for use in the upper and/or lower jaw to | |
| support prosthetic devices. The implants are manufactured from | |
| yttrium stabilized zirconium oxide bioceramics material |
1
conforming to ISO 13356-2008: Implants for surgery-ceramic materials based on yttria-stablized tetragonal ziconia (Y-TZP). The implant has a one-piece design (both implant and abutment), which simplifies the surgical procedures.
The implants are single use devices and are delivered in sterile condition have been sterilized with moisture heat. Zibone ceramic dental implants are also subjected to a sandblasting process that is used to impart the surface of the devices to enhance the osseointegration process.
Zibone dental implants are offered in three diameters (3.6mm, 4mm and 5mm) and 5 insertion lengths (8mm, 10mm, 11.5mm, 13mm and 14.5mm) for different teeth. The general rule is to select largest and longest implant size that the indication permits.
| Item | Subject Device | Predicate Device |
|---|---|---|
| 510(k) Number | K062542 | |
| FDA regulation no. | 872.3640 | 872.3640 |
| Device Name | Zibone ceramic dental implant system | Z-Look3 dental implant system |
| Manufacturer | Coho Tech Co., Ltd. | Z-Systems AG |
| Intended Use | To be surgically place in the upper or lower jaw to provide support for dental prosthetics and restore chewing functions. | Same |
| Device Configuration | Screw Type | |
| One-Piece; without the need to attach an abutment | Screw Type | |
| One-Piece; without the need to attach an abutment | ||
| Device Dimension | Diameter: 3.6, 4.0, 5.0mm | |
| Insertion length: 8, 10, 11.5mm, 13mm and 14.5mm | Diameter: 3.6, 4.0, 5.0mm | |
| Insertion length: 10mm, 11.5mm, 13mm and 14mm | ||
| Material Composition | Zirconium Oxide | Zirconium Oxide |
| Surface Treatment | Sandblast | Sandblast |
| Sterilization Method | Moisture Heat | Moisture Heat |
7. Substantial Equivalence:
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Summary of substantial Equivalence Comparison
The Zibone Dental Implant System has the same device characteristics as the predicate device -- Z-lock3 dental implant system (K062542), intended use, material, design, surface treatment, sterilization method. Even slight differences in design characteristics and dimension do not affect the submission of the device. Therefore, we state that Zibone Ceramic Dental Implant System is substantially equivalent to predicate device.
- The following were reviewed to support the performance of Zibone Summary of 8. Ceramic Dental Implant System: Fatigue test to ISO 14801, Nonclinical Testing: Sterilization validation, Shelf life testing, Surface analysis & Biocompatibility testing.
- No Clinical studies are submitted. 9. Summary of Clinical Testing:
- The Zibone Ceramic Dental Implant System has the same Conclusions: 10. indication for use , the same basic designs and materials, the same surface treatment and the same sterilization method as the Z-Look3 Dental Implant System (K062542) marketed by. Z-Systems AG. Moreover, bench testing contained in this submission demonstrates that any differences do not raise any new questions of safety or effectiveness. Thus, the Zibone Ceramic Dental Implant System is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-Gib09 Silver Spring, MD 20993-0002
June 4, 2014
Coho Technology Company Limited C/O Jennifer Reich Senior Consultant Harvest Consulting Corporation 2904 N. Boldt Drive Flagstaff, AZ 86001
Re: K132585
Trade/Device Name: Zibone Ceramic Dental Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseus Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 24, 2014 Received: May 5, 2014
Dear Ms. Reich:
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). and Oosinene fore, 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 warrantics. 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 n your device 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.
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Page 2 - Ms. Reich
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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mary's Runner -S
Erin 1. 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
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003_Indications for Use Statement (C)
ﺮ ﻣﺼﺮ
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Zibone Ceramic Dental Implant System COHO TECHNOLOGY CO., LTD.
Indications for use:
Zibone one-piece ceramic dental implants are indicated for implantation into the upper or lower jaw to replace missing teeth. They are indicated for (delayed or immediate) loading once primary stability has been achieved.
V Prescription Use (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)
Sheena A. Greena 2014.06.04 13:23
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