NEODENT IMPLANT SYSTEM

K133510 · Jj Industria E Comercio DE Materiais Dentarios SA · DZE · Feb 24, 2014 · Dental

Device Facts

• Record ID: K133510
• Device Name: NEODENT IMPLANT SYSTEM
• Applicant: Jj Industria E Comercio DE Materiais Dentarios SA
• Product Code: DZE · Dental
• Decision Date: Feb 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

Endosseous dental implant system; includes threaded, self-tapping, root-form implants and various abutments (straight, angled, ball-type, Equator attachments). Implants feature grit-blasted, acid-etched endosseous surfaces with smooth machined collars. Used by dental surgeons in clinical settings to replace missing teeth. Implants surgically placed in jaw bone; abutments attached to provide support for prosthetic restorations. System supports single or multiple unit restorations; allows immediate loading if primary stability is achieved. Benefits include restoration of chewing function and prosthetic support. Device components are provided sterile.

Clinical Evidence

No clinical data submitted. Substantial equivalence demonstrated via non-clinical bench testing, including biocompatibility, dimensional analysis, and static/dynamic compression-bending fatigue testing per ISO 14801.

Technological Characteristics

Implants: Commercially pure titanium (ASTM F67). Abutments: Titanium alloy (ASTM F136). Design: Threaded, self-tapping, root-form endosseous implants with grit-blasted/acid-etched surface and smooth machined collar. Various diameters (3.3-5.0 mm) and lengths (8-19 mm). Abutments include Smart Mount, Conical, Angled, and Equator attachments. Sterilization: Validated processes consistent with predicates.

Indications for Use

Indicated for patients requiring dental restoration via endosseous implants in the upper or lower jaw to support prosthetic devices (artificial teeth) and restore chewing function. Applicable for single or multiple unit restorations; single or two-stage surgical procedures; immediate loading permitted given primary stability and appropriate occlusal loading.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Neodent Implant System (K101207)
• Neodent Implant System (K101945)
• Neodent Implant System (K123022)

Submission Summary (Full Text)

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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 SA<br>Av. Juscelino Kubitschek de Oliveira, 3291 - CIC | |
|---------------------------|---------------------------------------------------------------------------------------------------------|--------------------|
| | Curitiba, Paraná, 81270-200, Brazil | |
| | Telephone: | [phone] |
| | Fax: | [phone] |
| 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 | [phone] |
| | Fax | [phone] |
| | Email | [e-mail] |

### 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

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.

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## 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.

## 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

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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.

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)

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Susan Runner
Mary S. Runner -S
DDSPM 2014.02.24
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