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.

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.

AI/ML Overview

The provided text describes a 510(k) submission for the Zit-z Dental Implant System, focusing on its substantial equivalence to previously cleared devices. The "study" mentioned is primarily a conformity assessment based on existing standards and predicate devices, rather than a prospective clinical trial designed to prove device performance against specific acceptance criteria in a robust statistical manner as one might expect for novel technology.

Here's an analysis based on your requested criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense with corresponding reported device performance metrics that are typically seen in studies for AI/software devices (e.g., sensitivity, specificity, AUC). Instead, the submission focuses on demonstrating substantial equivalence based on material properties, design, and existing standards.

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical Integrity/Durability: Satisfactory fatigue resistance in accordance with ISO 14801.	"Fatigue testing according to ISO 14801 was completed satisfactorily."
Clinical Efficacy/Safety: Ability to function as intended for support of prosthetic devices, restoring esthetics and chewing function, with no significant safety issues.	"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." (This points to the assumption of equivalence based on predicate's performance.)
Biocompatibility/Material Equivalence: Material (Y-TZP) is equivalent to legally marketed predicate devices.	Material is "Y-TZP" and "of the same material (zirconia)...as Nobel Biocare's ceramic implant and the Z-Look3." A difference in Y-TZP preparation method (coating vs. co-precipitation) is noted, but implied to be equivalent.
Design Equivalence: Similar design (one-piece screw implant) and dimensions (diameter, length) to predicate devices.	"one-piece screw implant." Diameters and lengths are "within the range cleared for Z-Look3."

2. Sample Size Used for the Test Set and Data Provenance

Test Set (Clinical Data): The document mentions "Canine data was submitted" and "Successful clinical case study data was provided along with some cases of human histology." Specific sample sizes are not provided.
Data Provenance: The document states "Canine data" (animal study) and "clinical case study data" with "human histology."
- The term "clinical case study data" suggests retrospective data or a small, possibly observational, prospective series rather than a large, controlled clinical trial. The origin country is not specified for these clinical cases, but the manufacturer is based in Germany.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable. The submission does not describe a process for establishing ground truth via expert consensus in the way one would for diagnostic or AI algorithm studies. The "clinical case study data" and "human histology" would have been evaluated by treating clinicians and pathologists, but their specific number, role in establishing a 'ground truth' for a test set, or qualifications are not described. The evaluation seems to be focused on the successful outcome of the implant procedure itself, rather than assessing an interpretation.

4. Adjudication Method for the Test Set

Not Applicable. No formal adjudication method (like 2+1, 3+1) is mentioned, as the "study" described is not an interpretation task but rather a conformity and performance assessment of a medical device (dental implant).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is relevant for evaluating human interpretation performance, often with and without AI assistance. This submission describes an implantable device, not a diagnostic imaging or AI interpretation tool. Therefore, such a study was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This is not an algorithm or AI device. The "device" is a physical dental implant. Standalone performance, in this context, refers to the implant's mechanical and biological performance independently, which is partially addressed by the ISO 14801 fatigue testing.

7. The Type of Ground Truth Used

Clinical Outcomes/Histology/Mechanical Testing:
- For the "clinical case study data," the 'ground truth' would be the successful long-term integration and function of the implant in patients, observed through clinical follow-up.
- "Human histology" would provide a 'ground truth' on the tissue-implant interface and bone integration.
- For fatigue testing, the 'ground truth' is compliance with the ISO 14801 standard, where the implant either passes or fails the specified load cycles.

8. The Sample Size for the Training Set

Not Applicable. This document does not describe an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no AI/ML algorithm or "training set," this question is not relevant to the provided text.

Summary

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K092507

510(k) Summary of Safety and Effectiveness May 11, 2010

Submitted by:	Steffen KahdemannManaging Director
Address:	ZiterionBahnhofstrasse 3Uffenheim, 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:

Indications for Use:

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:

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

Regulation Number and Section

§ 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.