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.

Titamax WS implant is indicated for a delayed loading protocol.

The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

Device Description

The Neodent Implant System implants included in this submission are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. They are designed to provide support for prosthetic teeth to restore chewing function. They are made of commercially pure titanium or titanium alloy, with a surface that is grit blasted and acid etched. In addition, multiple abutments made of titanium alloy are provided for each implant for both cement-retained and screw-retained prostheses. The CM Drive implant comes in three diameters (3.5, 4.3 and 5.0 mm), each in five lengths (8.0, 10.0, 11.5, 13.0, and 16.0 mm). The Titamax WS implant design comes in three diameters (4.0, 5.0, and 6.0 mm) with corresponding platform diameters. The 4.0 mm diameter Titamax WS implant comes in one length (6.0 mm). The 5.0 and 6.0 mm diameter Titamax WS implants come in two lengths (5.0 and 6.0 mm). The Facility implant design comes in one diameter (2.9 mm), and in five lengths (8, 10, 12, 14, and 16 mm). All abutments included in this submission are straight and have a Morse taper connection.

AI/ML Overview

The provided 510(k) summary for the Neodent Implant System does not contain information related to acceptance criteria or a study proving device performance against such criteria.

The document is a premarket notification for a medical device (dental implants). It focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving performance against specific acceptance criteria through a clinical study or benchmark performance testing with ground truth.

Therefore, many of the requested elements cannot be extracted from this document, as they are not present in a "substantial equivalence" submission for this type of device.

Here's an breakdown of what can be stated based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not specified (No explicit acceptance criteria for performance are outlined in this 510(k) submission.)	Not applicable (No performance metrics are reported against specified criteria.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. No clinical or performance test data on a "test set" are presented.
Data Provenance: Not applicable. The submission explicitly states: "Clinical data were not submitted in this premarket notification." The non-clinical data mentioned (engineering analysis, dimensional analysis, comparative surface area analysis) would not typically involve a "test set" in the sense of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As no clinical or performance test data are presented, there is no "ground truth" established by experts for a test set in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication is mentioned.

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 is a submission for a physical medical device (dental implants), not an AI diagnostic tool. No MRMC study was done, nor is AI assistance relevant to this device.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No performance data requiring ground truth ascertainment is presented. The submission relies on "substantial equivalence" based on design, materials, and non-clinical characteristics (engineering, dimensional analysis) comparing the new device to existing predicate devices.

8. The sample size for the training set

Not applicable. As no machine learning or AI model is involved, there is no "training set."

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

Not applicable. No machine learning or AI model is involved, so no training set or ground truth for it was established.

Summary based on the provided document:

The 510(k) summary for the Neodent Implant System explicitly states: "Clinical data were not submitted in this premarket notification." The submission focuses on demonstrating that the new components of the Neodent Implant System are "substantially equivalent" to predicate devices already cleared for market. This equivalence is based on:

Identical intended use.
Similar design, identical material, and identical surface to a previously cleared Neodent system (K101945).
Similar indications, design, and dimensions to other predicate devices for the new Titamax WS and Facility implants.
Non-clinical data including engineering analysis, dimensional analysis, and comparative surface area analysis.

The conclusion drawn is that "The device is safe and effective for its intended use and performs as well as or better than the predicate devices," based on the comparison of an existing cleared device characteristics rather than new performance data against specific acceptance criteria.

Summary

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510(k) Summary

Neodent Implant System

510(k) Summary

MAY 1 7 2013

JJGC Indústria e Comércio de Materiais Dentários SA Neodent Implant System

K123022

May 6, 2013

ADMINISTRATIVE INFORMATION

Manufacturer Name:

JJGC Indústria e Comércio de Materiais Dentários SA Av. Juscelino Kubitschek de Oliveira, 3291 - CIC Curitiba - PR - CEP, 81270-200, Brazil Telephone: +55 41 2169 4071 +55 41 2169 4041 Fax:

Official Contact

Representative/Consultant

Daniel Lecuona General Manager

Allison C. Komiyama, Ph.D. Linda K. Schulz, BSDH, RDH PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone: +1 (858) 792-1235 +1 (858) 792-1236 Fax: akomiyama@paxmed.com Email: lschulz@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name:

Classification Regulations: Product Code

Classification Panel: Reviewing Branch:

Neodent Implant System Endosseous dental implant Endosseous dental implant abutment 21 CFR 872.3640 . DZE NHA Dental Products Panel Dental Devices Branch

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510(k) Summary

INTENDED USE

Titamax WS implant is indicated for a delayed loading protocol.

The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

The subject device is substantially equivalent to the following predicate devices: K 101945, K 070601, K 080598, K 073343, K 092594, K 081653, K 050712, and K 0 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8 1 0 1 8

The Neodent Implant System expands the currently cleared system to include new designs of implants and their corresponding cement- or screw-retained abutments. The implants of the subject Neodent Implant System have a similar design, identical material and identical surface as those cleared under K 101945. The new Titamax WS implant is similar in indications, design and dimensions to the Bicon devices cleared in K092035, K050712, and K010185. The new Facility implant is similar in indications, design and dimensions to the Intra-Lock devices cleared in K070601 and K080598, the Ace Surgical Supply devices cleared in K073343 and K092594, and the IMTEC Corporation devices cleared in K081653. The abutments of the subject Neodent Implant System have a similar design and identical material as those cleared under K101945.

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: engineering analysis, dimensional analysis and comparative surface area analysis. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

Clinical data were not submitted in this premarket notification.

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510(k) Summary

CONCLUSIONS

The subject device and the predicate devices have the same intended use, have the same technological characteristics, and are made of the same materials. The subject device and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height and angle of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods. Any differences in the technological characteristics do not raise new issues of safety or efficacy. The device is safe and effective for its intended use and performs as well as or better than the predicate devices.

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Public Health Service

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

May 17, 2013

JJGC Indústria e Comércio de Materiais Dentários SA C/O Allison C. Komiyama Ph.D. Senior Regulatory Specialist PaxMed International, Limited Liability Company 11234 El Camino Real. Suite 200 SAN DIEGO CA 92130

Re: K123022

Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: April 18, 2013 Received: April 19, 2013

Dear Dr. Komiyama:

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 - Dr. Komiyama

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 devicerelated 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 vours.

Kwame O. Ulmer -S for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Indications for Use

510(k) Number: 1123022

Device Name: Neodent Implant System

Indications for Use:

Titamax WS implant is indicated for a delayed loading protocol.

The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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) Page 1 of 1 Ision Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital Division of Antost. Dental Devices 510(k) Number

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.