ZTI IMPLANTS SYSTEM, DRM IMPLANTS by DRM RESEARCH LABORATORIES, INC.

The permanent post-type implants of this system are 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 patient's chewing function.

The temporary implants are intended to provide immediate transitional splinting stability or fixation of new or existing crown, bridge and denture installations in partially or fully edentulous patients. It is indicated for a maximum of one year.

Device Description

The ZTI Implants System implants are post-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. The ZTI Implants system is most similar to the Straumann ITI Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-955281 and the ITI TE "" system in general. Like many commercial implants, the ZTI devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium)..

ZTI Implants also are available in coated form, either hydroxyapatite or titanium plasma spray, These devices are equivalent to various coated endosseous implants on the market, for example the Sabertech implants of Genentech, Inc., which were cleared under K-924112 and the Crystal-Seal Implants of Crystal Technology, cleared under K-980447.

AI/ML Overview

This 510(k) summary for the ZTI Implants System does not contain the detailed information required to fill out the table and answer all the questions as it is a substantial equivalence submission, not a performance study report. The device is determined to be substantially equivalent to pre-amendment devices and other commercially available dental implants. Therefore, the submission relies on the established safety and effectiveness of its predicate devices rather than presenting a de novo study with specific acceptance criteria and performance data for this particular device based on new testing.

Here's what can be extracted and why certain information is missing:

Acceptance Criteria and Study for ZTI Implants System

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Metric	Reported Device Performance	Comments
Not Applicable	This 510(k) submission relies on substantial equivalence, not specific performance criteria for independent testing of this device.	The submission asserts the device is "quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device."	The safety and effectiveness are inferred from the predicate devices (e.g., Straumann ITI Implants System) and the general body of literature on endosseous implants.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. No new test set data is presented for this specific device to determine performance against acceptance criteria.
Data Provenance: Not applicable in the context of a de novo performance study. The submission refers to a general literature review ("Medline literature search produced over 700 review articles") of endosseous implants and a "Toronto 10-year study" on the Branemark implant technique, which are external to specific testing of the ZTI Implants System.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No new test set requiring expert ground truth establishment for this device is mentioned. The submission refers to a "Consensus Development Conference on Dental Implants [National Institutes of Health, Bethesda, MD, June 13-15, 1988]," indicating a general consensus in the field, not specific to this device's testing.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental implant, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical dental implant, not an algorithm.

7. The type of ground truth used

The ground truth relies on historical clinical evidence and consensus within the dental community regarding the performance of endosseous dental implants, especially titanium or titanium alloy, of similar design and materials. The submission cites established literature reviews, consensus conferences, and long-term studies (like the Toronto study on Branemark implants) as evidence of safety and effectiveness for this class of devices. It is not about a specific ground truth for an evaluation of this particular device.

8. The sample size for the training set

Not applicable. This is a medical device (dental implant), not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set.

Summary Explanation:

The K034067 submission is a 510(k) Premarket Notification, which seeks to demonstrate that the ZTI Implants System is substantially equivalent to legally marketed predicate devices. This regulatory pathway primarily relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness as compared to a predicate device.

Therefore, the submission typically does not include new, independent clinical studies with specific acceptance criteria, performance metrics, or details about test and training sets. Instead, it references the established safety and efficacy of the predicate devices and the general scientific consensus in the field of dental implants. The "Clinical Discussion and Brief Literature Review" section serves to underpin the general safety and effectiveness of the type of device, not to report specific performance data for the ZTI Implants System itself.

Summary

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K034067

MAR - 8 2004

XIV. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DATA. (Separate Page)

A: Submitter: Dr. Samuel Waknine, President, DRM Research Laboratories, Inc., Branford, CT 06405.

I. Classification Name and Number: Endosseous Implant (76DZE),

II. Common/Usual Name: Dental Implant. Endosseous, Post (or screw )-type, titanium or titanium alloy.

III. Proprietary Name: ZTI Implants System

IV. Classification: This device is being finally classified by the Dental Devices Panel (Tiftle 21 CFR 872.3640.

V. Performance standards: None applicable. Materials meet ASTM voluntary standards

VI. Description: The ZTI Implants System implants are post-type endosseous dental implants with design and manufacturing concepts, materials, surgical procedures, and intended uses quite similar to the preamendment device and to others rated substantially equivalent to the preamendment device. The ZTI Implants system is most similar to the Straumann ITI Implants System which received concurrence of substantial equivalence from the Food and Drug Administration in premarket notification submission K-955281 and the ITI TE "" system in general. Like many commercial implants, the ZTI devices are manufactured of high-purity (99+%) titanium, or titanium alloy (ASTM F 136-84 titanium - 6 aluminum - 4 vanadium)..

VII. Labels and Instructions for Use are provided, as are labels for competitive products.

VIII. Intended Use: These devices are intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices and to restore the patient's chewing function.

VII. Substantial Equivalence: This device is equivalent to devices manufactured and sold before 1976,having a U. S. classification number of 76 DZE, and those described under 21 CFR 872.3640. It is also equivalent to several devices currently on the market that have been determined by the FDA to be substantially equivalent to the above preamendment devices. particularly to the Straumann ITI TE system cleared under K-955281. Some examples of other equivalent products are

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Driskell Bioengineering, Westerville, OH, K-853788, DB Precision Implant Steri-Oss (Subs. Denar, Anaheim, CA.), Denar Dental Implant, K-852802; Steri-Oss Implant, K-884845.

Stryker Instruments, Kalamazoo, MI, K-921805, Stryker Precision System.In

VIII. Clinical Discussion and Brief Literature Review: Endosseous implants, and especially those of titanium or titanium alloy, in the "post" or "screw" configuration, have been proved safe and effective through the years. The possible adverse effects summarized in this 510(k) cover those listed by the United States classification panel [Federal Register, vol. 45, No. 251, pp 86025-6, Dec. 30, 1980], as well as to those revealed in a recent literature search. Matukas, "Medical Risks Associated with Dental Implants," states, "Little or no hard data could be found on the medical risks associated with [dental] implants." Because of the wide-spread usage of dental implants, Smith and Zarb made a careful review of the literature and proposed criteria for implant success.

A thorough cornputerized Medline literature search produced over 700 review articles. The Journal of Dental Education published a special issue "Proceedings of the Consensus Development Conference on Dental Implants [National Institutes of Health, Bethesda, MD, June 13-15, 1988], Vol. 52, No. 12, pp. 677-831, Dec. 1988. This added to the literature search above, with some especially pertinent reprints from the scientific literature, provide a comprehensive summary of available scientific data.

Zarb completed his report of the detailed Toronto 10-year study by concluding that "the tried and tested Branernark implant technique has revolutionized the treatment options open to the prosthodontist. For the edentulous patient...the prospect for a lifetime of restored oral comfort, function, and appearance have now become predictable and reliable." These results are ample evidence of the safety and effectiveness of these endosseous implants.

END OF 510(k) SUMMARY

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 8 2004

Dr. Samuel Waknine President DRM Research Laboratories. Incorporated 29 Business Park Drive Branford, Connecticut 05405

Re: K034067

Trade/Device Name: ZTI Implant System™ DRM Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: February 23, 2004 Received: March 3. 2004

Dear Mr. Waknine:

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 vour 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. Waknine

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 (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.

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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. 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): K034067

Device Name: ZTI Implants System™

Indications for Use:

Prescription Use x AND/OR (Part 21 CFR 801 Subpart D)

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)

Susan Quares

510(k) Number: K(34)067

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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.