NEODENT IMPLANT SYSTEM, TITAMAX TI EX ACQUA AND TI DRIVE ACQUA, TITAMAX SMART EX ACQUA AND DRIVE SMART ACQUA, TITAMAX CM by NEODENT USA, INC.

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

Device Description

The subject Titamax Ti EX Acqua implants are provided in the same design variants as the predicate Titamax Ti EX implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Titamax Ti EX Acqua are provided in two endosseous diameters (3.75 and 4.0 mm), one platform diameter (4.1 mm), and five lengths (9, 11, 13, 15, and 17 mm).
The subject Ti Drive Acqua implants have the same tapered, single thread design variants as the predicate CM Drive implants and the same external hex abutment interface and internal geometry as the predicate HE series implants. They also have the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Ti Drive Acqua implants are provided in three endosseous diameters (3.5, 4.3, and 5.0 mm), three platform diameters (3.3, 4.3, and 5.0 mm), and five lengths (8, 10, 11.5, 13, and 16 mm).

The subject Titamax CM EX Acqua implants are provided in the same design variants as the predicate Titamax CM EX implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Titamax CM EX Acqua implants are provided in three endosseous diameters (3.5, 3.75, and 4.0 mm), three platform diameters (3.5, 3.75, and 4.0 mm), and five lengths (9, 11, 13, 15, 17 and 19 mm).

The subject CM Drive Acqua implants are provided in the same design variants as the predicate Titamax CM EX implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The CM Drive Acqua implants are provided in three endosseous diameters (3.5, 4.3, and 5.0 mm), three platform diameters (3.3, 4.3, and 5.0 mm), and five lengths (8, 10, 11.5, 13, and 16 mm).

The subject Titamax Smart EX Acqua implants are provided in the same design variants as the predicate. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Titamax Smart EX Acqua implants are provided in two endosseous diameters (3.75 and 4.0 mm), one platform diameter (4.1 mm), and five lengths (9, 11, 13, 15, and 17 mm).

The subject device Drive Smart Acqua implants are provided in the same design variants as the predicate Drive Smart implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Drive Smart Acqua implants are provided in three endosseous diameters (3.5, 4.3, and 5.0 mm), three platform diameters (3.3, 4.3, and 5.0 mm), and five lengths (8, 10, 11.5, 13, and 16 mm).

The Acqua surface finish is a traditional grit blast and acid etch surface that is further processed in a manner that renders it hydrophilic.

The subject implant devices are made of Grade 4 commercially pure titanium conforming to ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), with a surface that is grit blasted, acid etched and subjected to a process that renders them hydrophilic. The subject Smart mount devices are made of titanium alloy conforming to ASTM F136 Standard for Titanium-6Aluminum-Specification 4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401).

AI/ML Overview

The provided text describes the Neodent Implant System's 510(k) summary (K133592) and its substantial equivalence determination by the FDA. However, it does not contain information about acceptance criteria, specifics of a study proving device performance against acceptance criteria, or details regarding ground truth establishment, sample sizes for test/training sets, expert qualifications, or adjudication methods in the context of an AI/algorithm-based device as requested in the prompt.

The document primarily focuses on demonstrating the substantial equivalence of the Neodent Implant System to legally marketed predicate devices based on design, materials, surface treatment, and intended use.

Here's a breakdown of what can be extracted and what is missing based on your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided text. The document states that "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include engineering analysis and dimensional analysis. Bench testing and animal testing were submitted to characterize the Acqua surface." However, it does not specify any quantitative acceptance criteria or the reported performance metrics against those criteria.

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

This information is not available. The document mentions bench testing and animal testing but provides no details on sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not available. The document does not describe any process of establishing ground truth by experts, as it's not detailing a diagnostic AI/algorithm.

4. Adjudication Method for the Test Set:

This information is not available. Adjudication methods are typically relevant for human review of results, which is not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and Effect Size:

No. The document explicitly states: "Clinical data were not submitted in this premarket notification." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or reported.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

No. The device is a physical dental implant system, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable or discussed.

7. The Type of Ground Truth Used:

This information is not available. For a physical device, "ground truth" often refers to established engineering specifications, material properties, or biological outcomes. While the document mentions demonstrating substantial equivalence through "engineering analysis and dimensional analysis" and characterizing the "Acqua surface" through "bench testing and animal testing," it does not explicitly define what "ground truth" was used or how it was established for these tests.

8. The Sample Size for the Training Set:

This information is not available. As the device is not an AI/algorithm, there is no concept of a "training set" in the context of the provided document.

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

This information is not available (not applicable, as there's no training set).

Summary of what is present:

Device Name: Neodent Implant System
Intended Use: "surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted."
Basis for Approval: Substantial equivalence to previously cleared predicate devices (K101207, K101945, K123022, K133510, and K033984 for the SLActive surface).
Performance Data Submitted: Non-clinical data including engineering analysis, dimensional analysis, bench testing, and animal testing to characterize the Acqua surface.
Clinical Data: "Clinical data were not submitted in this premarket notification."

The provided text describes a regulatory submission for a physical medical device (dental implants), not a diagnostic AI or algorithm. Therefore, many of the questions related to AI/algorithm validation (ground truth, expert adjudication, MRMC studies, training/test sets) are not addressed in this document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing to the right. The profiles are connected and flow together, creating a sense of unity and collaboration.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 22, 2014

Neodent USA Incorporated Christopher Klaczyk Director of Regulatory Affairs 60 Minutemen Road Andover, MA 01810

Re: K133592

Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: July 24, 2014 Received: July 25, 2014

Dear Mr. Klaczyk:

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. Klaczyk

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/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. 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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4. Indications For Use

510(k) Number (if known):

Device Name: Neodent Implant System

Indications for Use:

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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5. 510(k) Summary

Manufacturer:	JJGC Indústria e Comércio de Materiais Dentários SAAv. Juscelino Kubitschek de Oliveira, 3291 - CICCuritiba, Paraná, 81270-200, BrazilTelephone: +55 41 2169 1003Fax: +55 41 2169 1043Establishment Registration No. 3008261720
Official Contact:	Jafte Carneiro Fagundes da SilvaChief Compliance, Legal and Regulatory Officer – CCLRO
Sponsor:	Christopher KlaczykNeodent USA, Inc.60 Minuteman RoadAndover, MA 01810Telephone +1 (978) 747-2572Fax +1 (978) 747-0023Email regulatory@neodentusa.comEstablishment Registration No. Pending
Date Prepared:	November 21, 2013
Product Code(s):	DZE (21 CFR 872.3640)
Device Class:	II (21 CFR 872.3640)
Classification Panel: Dental Devices
Classification Name: Endosseous dental implant
	Proprietary Name: Neodent Implant System
	Predicate Device(s): Neodent Implant System is substantially equivalent inindications and design principles to the following legallymarketed predicate devices:JJGC Indústria e Comércio de Materiais Dentários SA,Neodent Implant System, K101207 JJGC Indústria e Comércio de Materiais Dentários SA,Neodent Implant System, K101945 JJGC Indústria e Comércio de Materiais Dentários SA,Neodent Implant System, K123022 JJGC Indústria e Comércio de Materiais Dentários SA,Neodent Implant System, K133510

" Institut Straumann AG, SLActive Implants, K033984

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Device Description: The subject Titamax Ti EX Acqua implants are provided in the same design variants as the predicate Titamax Ti EX implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Titamax Ti EX Acqua are provided in two endosseous diameters (3.75 and 4.0 mm), one platform diameter (4.1 mm), and five lengths (9, 11, 13, 15, and 17 mm).
The subject Ti Drive Acqua implants have the same tapered, single thread design variants as the predicate CM Drive implants and the same external hex abutment interface and internal geometry as the predicate HE series implants. They also have the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Ti Drive Acqua implants are provided in three endosseous diameters (3.5, 4.3, and 5.0 mm), three platform diameters (3.3, 4.3, and 5.0 mm), and five lengths (8, 10, 11.5, 13, and 16 mm).

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diameter (4.1 mm), and five lengths (9, 11, 13, 15, and 17 mm).

The Acqua surface finish is a traditional grit blast and acid etch surface that is further processed in a manner that renders it hydrophilic.

Intended Use: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The subject implant devices are made of Grade 4 Materials: commercially pure titanium conforming to ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), with a surface that is grit blasted, acid etched and subjected to a process that renders them hydrophilic. The subject Smart mount devices are made of titanium alloy conforming to ASTM F136 Standard for Titanium-6Aluminum-Specification 4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401).
Performance Data: Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include engineering analysis and dimensional analysis. Bench testing and animal testing were submitted to characterize the Acqua surface. The data included in this submission demonstrate substantial equivalence to the referenced predicate devices.

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Clinical data were not submitted in this premarket notification.

Conclusions: The implants of the subject Neodent Implant System have a similar design and dimensions, use similar materials and have a similar surface topology as those cleared under K101207, K101945, K123022 and K133510. The Acqua hydrophilic surface treatment is similar to the SLActive surface cleared in K033984.
Based upon our assessment of the performance data, the subject device is safe and effective for its intended use and performs as well as the referenced predicate device(s).

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.