NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE

K102769 · Jjgc Industria E Comercio DE Materiais Dentarios S · OAT · Feb 23, 2011 · Dental

Device Facts

• Record ID: K102769
• Device Name: NEODENT IMPLANT FOR ORTHODONTIC ANCHORAGE
• Applicant: Jjgc Industria E Comercio DE Materiais Dentarios S
• Product Code: OAT · Dental
• Decision Date: Feb 23, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This product is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures.

Device Story

Neodent Implant for Orthodontic Anchorage is a single-piece, temporary, self-drilling screw implanted into bone; provides fixed anchorage point for orthodontic appliances. Used by clinicians in dental settings to facilitate tooth movement. Device features threaded shaft for bony fixation and low-profile head with conical transmucosal segment for attachment of orthodontic accessories. Benefits patient by providing stable anchorage for complex tooth movements.

Clinical Evidence

No clinical data. Substantial equivalence is based on design, material, and functional characteristics compared to legally marketed predicate devices.

Technological Characteristics

Material: Ti-6Al-4V titanium alloy. Design: Single-piece, self-drilling threaded shaft with low-profile head and conical transmucosal segment. Energy source: None (mechanical). Connectivity: None. Sterilization: Standard methods consistent with predicate devices.

Indications for Use

Indicated for use as a temporary screw for fixed anchorage to assist in orthodontic tooth movement procedures.

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

• ORLUS Mini Screw (K082838)
• Aarhus Anchorage System (K041527)
• Syntec Orthodontic Mini Screws (K090476)

Submission Summary (Full Text)

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510(k) Summary

Neodent Implant for Orthodontic Anchorage

FEB 2 3 2011

# 510(k) Summary

### JJGC Indústria e Comércio de Materiais Dentários SA

## Neodent Implant for Orthodontic Anchorage

September 23, 2010

### ADMINISTRATIVE INFORMATION :

KIB

| 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 | |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| | Telephone: | [phone] |
| | Fax: | [phone] |
| Official Contact: | Daniel Lecuona | |
| Representative/Consultant: | David J. Collette, MD<br>Kevin A. Thomas, PhD<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA 92130, USA | Telephone: [phone]<br>Fax: [phone]<br>email: [e-mail]<br>[e-mail] |

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Regulation: Product Code: Classification Panel: Reviewing Branch:

Neodent Implant for Orthodontic Anchorage Implant, Endosseous, Orthodontic 21 CFR 872.3640 OAT Dental Products Panel Dental Devices Branch

### INTENDED USE

This product is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures.

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#### DEVICE DESCRIPTION

The Neodent Implant for Orthodontic Anchorage (Neodent Anchor) is a device that is temporarily implanted into the bone to provide a fixed anchorage point for various orthodontic tooth movements. The single-piece design features a self-drilling threaded shaft for bony fixation and a low profile head having a conical transmucosal segment and points for attachment of various appliances to facilitate orthodontic movement of teeth.

### EQUIVALENCE TO MARKETED DEVICE

JJGC Indústria e Comércio de Materiais Dentários SA demonstrated that, for the purposes of FDA's regulation of medical devices, the Neodent Implant for Orthodontic Anchorage (Neodent Anchor) 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 preamendment devices:

ORLUS Mini Screw from Ortholution Company, Limited, cleared under K082838,

Aarhus Anchorage System from Medicon E.G., cleared under K041527, and

Syntec Orthodontic Mini Screws from Syntec Scientific Corporation, cleared under K090476.

The intended use, design, materials and functional characteristics of the Neodent Anchor and the predicate devices are substantially the same. All are indicated for temporary fixed anchorage of orthodontic appliances and accessories used in the movement of teeth. The basic design of each consists of a threaded shaft for bone anchorage and a contoured head for attachment of various orthodontic appliances and accessories. The subject and predicate devices are made of Ti-6Al-4V titanium alloy, a well-proven material for implantable devices. The subject and predicate devices encompass the same range of physical dimensions, and are packaged in similar materials and sterilized using similar methods.

Overall, Neodent Implant for Orthodontic Anchorage 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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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a symbol consisting of three curved lines that appear to be stylized representations of human figures.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WQ66-G609 Silver Spring, MD 20993-0002

JJGC Industria e Comercio de Materiais Dentarios SA C/O David Collette, MD Paxmed International. LLC 11234 El Camino Real Suite 200 San Diego, California 92130

FEB 2 3 2011

Re: K102769

Trade/Device Name: Neodent Implant for Orthodontic Anchorage Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: OAT Dated: February 14. 2011 Received: February 15, 2011

Dear Dr. Collette:

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. the submit and the subject of the states

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Page 2- Dr. Collette

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

Sincerely yours.

Susan Ruano

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): K (02769

Neodent Implant for Orthodontic Anchorage Device Name:

Indications for Use:

This product is a surgical device in the form of a temporary screw used as an aid in orthodontic movement procedures.

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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| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
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| 510(k) Number: | K102769 |