NEODENT IMPLANT SYSTEM

K101945 · Jjgc Industria E Comercio DE Materiais Dentarios S · DZE · Jan 26, 2011 · Dental

Device Facts

• Record ID: K101945
• Device Name: NEODENT IMPLANT SYSTEM
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
• Product Code: DZE · Dental
• Decision Date: Jan 26, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Neodent Implant System consists of threaded, self-tapping, root-form endosseous dental implants and associated abutments. Implants feature Morse taper interface; straight double-thread or tapered single-thread designs; grit-blasted and acid-etched surface. Abutments support cement-retained or screw-retained prostheses. Used by dental clinicians in clinical settings for surgical placement into jaw bone to support artificial teeth. System restores chewing function; allows immediate loading if primary stability is achieved. Benefits include structural support for prosthetic restorations.

Clinical Evidence

Bench testing only. Dynamic fatigue testing was performed in conformance with ISO 14801 to evaluate the strength of the Titamax CM Implants and CM Abutments. Results confirmed the system's structural integrity is sufficient for the intended use.

Technological Characteristics

Threaded, self-tapping, root-form endosseous dental implants with Morse taper abutment interface. Materials: Commercially pure titanium (ASTM F67), titanium alloy, gold alloy, zirconia. Surface: Grit-blasted and acid-etched. Dimensions: Various diameters and lengths. Sterilization: Standard methods. No software or electronic components.

Indications for Use

Indicated for patients requiring dental restoration via endosseous implants in the upper or lower jaw to support prosthetic devices and restore chewing function. Applicable for single or multiple unit restorations using single-stage or two-stage surgical procedures. Suitable for immediate loading given adequate 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

• Lifecore Biomedical Stage-1 Single Stage RBM Dental Implant System (K003226)
• Lifecore Biomedical Stage-1Angled Abutment System (K032495)
• Dentsply International, Inc., ANKYLOS® C/X Dental Implant System (K083805)
• Nobel Biocare NOBELSPEEDY™ Implants (K050406)
• Nobel Biocare Esthetic Zirconia Abutment (K031719)
• Straumann ITI® Dental Implant System (K033922)
• Straumann synOcta® Prosthetics (K041295)
• Straumann UCLA Gold Abutment (K022859)
• Astra Tech Fixture MicroThread™ OsseoSpeed™ (K053384)
• JJGC Indústria e Comércio de Materiais Dentários SA Neodent Implant System (K101207)

Submission Summary (Full Text)

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Summary

K10/945

Neodent Implant System

JAN 2 6 2011

## 510(k) Summary

# JJGC Indústria e Comércio de Materiais Dentários SA Neodent Implant System

January 25, 2011

## ADMINISTRATIVE INFORMATION

| Manufacturer Name: | JJGC Indústria e Comércio de Materiais Dentários SA<br>Av. Juscelino Kubitschek de Oliveira, 3291 – CIC<br>Curitiba - PR - CEP, 81270-200, Brazil<br>Telephone: [phone]<br>Fax: [phone] | |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Official Contact: | Daniel Lecuona | |
| Representative/Consultant: | Linda K. Schulz, BSDH, RDH<br>Kevin A. Thomas, PhD<br>PaxMed International, LLC | |
| | 11234 El Camino Real, Suite 200 | |
| | San Diego, CA 92130, USA | |
| | Telephone: | [phone] |
| | Fax: | [phone] |
| | email: | [e-mail]<br>[e-mail] |

### DEVICE NAME AND CLASSIFICATION

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

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#### INTENDED USE

The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower iaw 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 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 made of commercially pure titanium, with a surface that is grit blasted and acid etched. Implants are provided in both a straight, double thread design and a tapered, single thread design. In addition, multiple abutments are provided for each diameter implant for both cement-retained and screwretained prostheses.

#### TESTING

Testing was performed in conformance to ISO 14801 Dentistry - Implants - Dynamic fatigue tests for endosseous dental implants to ensure that the strength of the Titamax CM Implants in conjunction with CM Abutments is appropriate for the intended use. Results confirmed the strength of the system.

### EQUIVALENCE TO MARKETED DEVICE

The Neodent Implant System is substantially equivalent in indications and design principles to the following predicate devices, each of which has been determined by FDA to be substantially equivalent to pre-amendment devices:

Lifecore Biomedical Stage-1 Single Stage RBM Dental Implant System cleared under K003226.

Lifecore Biomedical Stage-1Angled Abutment System cleared under K032495, Dentsply International, Inc., ANKYLOS® C/X Dental Implant System cleared under K083805.

Nobel Biocare NOBELSPEEDY™ Implants cleared under K050406,

Nobel Biocare Esthetic Zirconia Abutment cleared uinder K031719.

Straumann ITI® Dental Implant System cleared under K033922,

Straumann synOcta® Prosthetics cleared under K041295,

Straumann UCLA Gold Abutment cleared under K022859, and

Astra Tech Fixture MicroThread™ OsseoSpeed™ cleared under K053384,

JJGC Indústria e Comércio de Materiais Dentários SA Neodent Implant System cleared under K101207.

The subject device and the predicate devices have the same intended use and have the same technological characteristics. The subject and predicate implants are all made of commercially pure titanium conforming to ASTM F67 and have similar surface treatments. The subject and

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#### Summary

predicate abutments are also made of the same materials (titanium alloy, gold alloy, zirconia). The subject and predicate devices encompass the same range of physical dimensions, including diameter and length of the implants, and diameter, height, and gingival height of the abutments. The subject and predicate devices are packaged in similar materials and sterilized using similar methods.

Overall, Neodent Implant System has the following similarities to the predicate devices:

- has the same intended use, .
- uses the same operating principle, .
- incorporates the same basic design, .
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JJGC Industria Commercio e Comercio de Materiais Dentarios SA C/O Linda K. Schulz Paxmed International, LLC 11234 El Camino Real. Suite 200 San Diego. California 92130

Re: K101945

JAN 2 6 2011

Trade/Device Name: Neodent Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: DZE, NHA Dated: January 13, 2011 Received: January 14, 2011

Dear Ms. Schulz:

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- Ms. Schulz

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Susan Turner

Anthony D. Watson, B.S., M.S., M.B.A. 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 (if known): 14/12/945

Device Name: Neodent Implant System

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.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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