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 purpose of this submission is to expand the Neodent Implant System components cleared under K101207, which included dental implants with an external hex abutment interface. The external hex additions include Titamax Smart EX, and Drive Smart implants that are provided with a new implant mount that can be used as a temporary abutment. Additional straight, angled and ball-type abutments with external hex interfaces are also included in this submission.

All of the subject device external implants are threaded, self-tapping, root form, endosseous dental implants with a grit blasted and acid etched endosseous surface. All implants have a smooth machined collar on the transgingival surface. The Titamax Smart implants are provided in five endosseous thread diameters (3.3, 3.75, 4.0, 4.5, 5.0 mm), three platform diameters (3.3, 4.1, 5.0 mm), and five overall lengths (9, 11, 13, 15, 17 mm). The Titamax Smart EX implants are provided in two endosseous thread diameters (3.75, 4.0 mm), one platform diameter (4.1 mm), and six overall lengths (9, 11, 13, 15, 17, 19 mm). The Drive Smart implants are provided in three endosseous thread diameters (3.5, 4.3, 5.0 mm), three platform diameters (3.3, 4.3, 5.0 mm), and five overall lengths (8, 10, 11.5, 13, 16 mm). All implants are made from commercially pure titanium conforming to ASTM F67.

This submission includes the following abutments: the Smart Mount in three platform diameters (3.3, 4.1/4.3, 5.0 mm); Conical Abutments (platform diameter 3.3 mm); Angled Mini Conical abutments angled 17° or 30°, in four platform diameters (3.3, 4.1, 4.3, 5.0 mm), and gingival heights from 2 mm to 5 mm; SF Universal Post abutments (platform diameter 4.5 mm); Angled Post abutments angled 17° or 30° in four platform diameters (3.3. 4.1. 4.3, 5.0 mm), and gingival heights from 2 mm to 5 mm; and Equator Attachments for overdentures or partial dentures in three platform diameters (4.1, 4.3, 5.0 mm) and gingival heights from 2 mm to 5 mm. All abutments are made from titanium alloy conforming to ASTM F136.

AI/ML Overview

The Neodent Implant System is a dental implant system designed to support prosthetic devices like artificial teeth to restore chewing function.

1. A table of acceptance criteria and the reported device performance

Criteria	Acceptance Criteria (Predicate Device K101207, K101945, K123022)	Reported Device Performance (Neodent Implant System)
Biocompatibility	Demonstrated	Demonstrated
Engineering Analysis	Demonstrated	Demonstrated
Dimensional Analysis	Demonstrated	Demonstrated
Static and Dynamic Compression-Bending Testing (ISO 14801)	Demonstrated equivalence or superiority to predicate devices	Demonstrated equivalence to predicate devices
Similar Design and Dimensions	Same range of physical dimensions (diameter, length of implants; diameter, height, angle of abutments)	Similar design and dimensions, same range of physical dimensions
Same Materials Used	Implants: Commercially pure titanium (ASTM F67); Abutments: Titanium alloy (ASTM F136)	Implants: Commercially pure titanium (ASTM F67); Abutments: Titanium alloy (ASTM F136)
Same Surface	Grit blasted and acid etched endosseous surface; smooth machined collar	Grit blasted and acid etched endosseous surface; smooth machined collar
Similar Packaging	Similar to predicate devices	Similar to predicate devices
Similar Sterilization Methods	Same materials and processes as predicate devices	Same materials and processes as predicate devices

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

Sample Size: Not explicitly stated in the provided text. The submission refers to "non-clinical data" for testing.
Data Provenance: The document does not specify the country of origin for the non-clinical data. It is a retrospective comparison to previously cleared predicate devices.

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

This information is not applicable to this submission. The "ground truth" for demonstrating substantial equivalence relied on engineering and material characteristic comparisons, not expert interpretation of clinical data or images.

4. Adjudication method for the test set

Not applicable. This was a non-clinical equivalence study, not a clinical trial requiring adjudication of patient outcomes or expert diagnoses.

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 submission is for a physical medical device (dental implants and abutments), not an AI-powered diagnostic or assistive tool.

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-based device.

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

The ground truth used for demonstrating substantial equivalence was based on engineering standards, material specifications, and physical performance testing (e.g., fatigue testing according to ISO 14801), comparing the subject device's attributes to those of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable. There is no training set for this device.

Summary

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Neodent Implant System

FEB 2 4 2014

な

510(k) Summary

JJGC Indústria e Comércio de Materiais Dentários SA

Neodent Implant System

November 15, 2013

Manufacturer Name	JJGC Indústria e Comércio de Materiais Dentários SAAv. Juscelino Kubitschek de Oliveira, 3291 - CIC
	Curitiba, Paraná, 81270-200, Brazil
	Telephone:	+55 41 2169 1003
	Fax:	+55 41 2169 1043
Official Contact	Jafte Carneiro Fagundes da Silva
	Chief Compliance, Legal and Regulatory Officer – CCLRO
Representative/Consultant	Kevin A. Thomas, PhD
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
	Telephone	+1 (858) 792-1235
	Fax	+1 (858) 792-1236
	Email	kthomas@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	Neodent Implant System
Common Name	Endosseous dental implant
	Endosseous dental implant abutment
Classification Regulations	21 CFR 872.3640
Product Code	DZE
	NHA
Classification Panel	Dental Products Panel
Reviewing Branch	Dental Devices Branch

INTENDED USE

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DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED DEVICE

Neodent Implant System is substantially equivalent in indications and design principles to the following legally marketed 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, K 101945
JJGC Indústria e Comércio de Materiais Dentários SA, Neodent Implant System, K123022

The implants of the subject Neodent Implant System have similar designs and dimensions, use the same materials, and have the same surface as those cleared under K101207, K101945, and K 123022. The abutments of the subject Neodent Implant System have similar designs and are made from the same material as those cleared under K101207, K101945, and K123022.

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510(k) Summary

The subject device has similar packaging and is sterilized using the same materials and processes as described in K101207, K101945, and K123022.

Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility, engineering analysis, dimensional analysis, static and dynamic compression-bending testing according to ISO 14801 Dentistry - Implants - Dynamic fatigue test for endosseous dental implants. Fatigue testing demonstrated the subject device to be equivalent to the predicate devices.

Clinical data were not submitted in this premarket notification.

CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar 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.

The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of an eagle with its wings spread.

Public Health Service

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

February 24, 2014

JJGC Indústria e Comércio de Materiais Dentários SA C/O Dr. Kevin A. Thomas, PhD Regulatory Affairs PaxMed International, Limited Liability Company 12264 El Camino Real, Suite 400 San Diego, CA 92130

Re: K133510

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: January 28, 2014 Received: January 29, 2014

Dear Dr. Thomas:

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. Thomas

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/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 yours,

Image /page/4/Picture/8 description: The image shows the text "Kwame O Ulmer-s". The text is arranged in two lines, with "Kwame O" on the top line and "Ulmer-s" on the bottom line. The text is in a bold, sans-serif font. The background of the image is filled with a pattern of small squares and lines.

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

for

Enclosure

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510(k) Summary

Neodent Implant System

Indications for Use

K133510 510(k) Number:

Neodent Implant System Device Name:

Prescription Use X (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

Susan Runner
Mary S. Runner -S
DDSPM 2014.02.24
13:08:30 -05'00'

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.