(267 days)
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No
The summary describes a physical dental implant and its mechanical properties, with no mention of software, algorithms, or AI/ML capabilities.
No
The device, a dental implant, provides support for prosthetic devices to restore esthetics and chewing function, but it does not directly treat or cure a disease or medical condition.
No
Explanation: The device description and intended use clearly state that the Zit-z dental implants are for supporting prosthetic devices and restoring function, not for detecting, monitoring, or predicting diseases or conditions.
No
The device description clearly states it is a physical dental implant made from ceramic material, intended for surgical placement. There is no mention of software as the primary component or function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Zit-z Dental Implant Function: The description clearly states that the Zit-z dental implant is a surgically placed device intended to provide structural support for prosthetic devices within the bone of the jaw. It is a physical implant, not a device that analyzes biological samples.
- Intended Use: The intended use is to restore patient esthetics and chewing function by supporting artificial teeth. This is a mechanical and structural function, not a diagnostic one.
The information provided describes a medical device used for surgical implantation and prosthetic support, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Zit-z dental implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. They are indicated for single or multiple unit restorations in splinted or non-splinted applications. The zit-z dental implants are restored with fixed/cemented crowns and bridges. Not for immediate loading.
The 3.5mm implant is contraindicated for restorations of the posterior teeth in the upper or lower jaw and for single-tooth restoration of canines and central incisors in the upper jaw.
Product codes (comma separated list FDA assigned to the subject device)
DZE
Device Description
Zit-z Dental Implant System is a root-form dental implant system with a one-piece cylindrical screw implant design. They have a pentagonal geometry anti-rotation feature which also provides ease of insertion. They are made from HIP zirconium dioxide ceramics (3Y-TZP) which meets (SO 13356.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
bone of the upper or lower jaw arches
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Fatigue testing according to ISO 14801 was completed satisfactorily. Canine data was submitted. Successful clinical case study data was provided along with some cases of human histology. The nonclinical and clinical data show the implants can be used successfully and will withstand the fatigue forces necessary for their use.
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.
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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.
0
510(k) Summary of Safety and Effectiveness May 11, 2010
| Submitted by: | Steffen Kahdemann
Managing Director | |
|----------------------|----------------------------------------------------------|-------------|
| Address: | Ziterion
Bahnhofstrasse 3
Uffenheim, Germany 97215 | MAY 11 2010 |
| Telephone: | 49 9842 9369 0 | |
| Fax: | 49 9842 9369 10 | |
| Classification Name: | Endosseous dental implant 21 CFR 872.3640 | |
| Trade Name: | zit-z Dental Implant System | |
Legally Marketed Device: NobelBiocare Zirconia Implant K061971 and Z-systems Z-Look3 K062542
Device Description:
Zit-z Dental Implant System is a root-form dental implant system with a one-piece cylindrical screw implant design. They have a pentagonal geometry anti-rotation feature which also provides ease of insertion. They are made from HIP zirconium dioxide ceramics (3Y-TZP) which meets (SO 13356.
Indications for Use:
Zit-z dental implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. They are indicated for single or multiple unit restorations in splinted or non-splinted applications. The zit-z dental implants are restored with fixed/cemented crowns and bridges. Not for immediate loading.
The 3.5mm implant is contraindicated for restorations of the posterior teeth in the upper or lower jaw and for single-tooth restoration of canines and central incisors in the upper jaw.
Testing:
Fatigue testing according to ISO 14801 was completed satisfactorily. Canine data was submitted. Successful clinical case study data was provided along with some cases of human histology. The nonclinical and clinical data show the implants can be used successfully and will withstand the fatigue forces necessary for their use. The predicate device Z-Look3 has been used successfully clinically for several years and has not been found to have fatigue issues either.
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Technological Comparison:
| Characteristic | Zit-z | Z-Look3 |
|---|---|---|
| Design | One-piece screw implant | One-piece screw implant |
| Material | Y-TZP | Y-TZP |
| Implant Diameter | 3.5, 4.0, 5.0 | 3.25, 4.0, 5.0 |
| Implant Length | 10, 11.5, 13 | 10, 11.5, 13, 14 |
| Transgingival Height of Implant | 1.5, 2.5 | N/A |
Substantial Equivalence:
Zit-z implants are of the same material (zirconia) and of similar design (one-piece screw-type implant) as Nobel Biocare's ceramic implant and the Z-Look3. The Y-TZP powders in the predicate devices are prepared via coprecipitation of yttria and zirconia powders, but the Y-TZP used in zit-z is prepared by a newer method coating zirconia grains with yttria. The diameters and lengths available are within the range cleared for Z-Look3.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Steffen Kahdemann Managing Director Ziterion Bahnhofstrasse 3 Uffenheim GERMANY 97215
MAY 1 1 2010
Re: K092507
Trade/Device Name: Zit-z Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 19, 2010 Received: April 23, 2010
Dear Mr. Kahdemann:
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. Please note: CDRH does not evaluate information related to contract liability warranties. 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 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.
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Page 2- Mr. Kahdemann
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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours,
for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, ·Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ห้ง9 ปรุง 7
Device Name: zit-z
Indications for Use:
Zit-z dental implants are root-form endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. They are indicated for single or multiple unit restorations in splinted or non-splinted applications. The zit-z dental implants are restored with fixed/cemented crowns and bridges. Not for immediate loading.
The 3.5mm implant is contraindicated for restorations of the posterior teeth in the upper or lower jaw and for single-tooth restoration of canines and central incisors in the upper jaw.
Prescription Use (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092507