NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING

K033171 · Northern Implants, LLC · DZE · Apr 27, 2004 · Dental

Device Facts

• Record ID: K033171
• Device Name: NSI HEXED AND NON-HEXED IMPLANT SYSTEM AND IMMEDIATE LOADING
• Applicant: Northern Implants, LLC
• Product Code: DZE · Dental
• Decision Date: Apr 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multiple-unit implant restorations supported by a minimum of four implants anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

Device Story

NSI Hexed and Non-Hexed Implant System consists of endosseous dental implants and accessories; used to support fixed or removable dental prostheses in upper or lower jaw arches. Device allows for immediate placement and function in the mandible for splinted multiple-unit restorations anterior to the mental foramen. Operated by dental professionals in clinical settings. System provides structural support for prosthetic teeth; restores chewing function. Benefit includes immediate restoration capability when primary stability is achieved.

Clinical Evidence

No clinical studies were conducted or deemed necessary for this 510(k) submission.

Technological Characteristics

Endosseous dental implants and accessories. Design and physical properties are comparable to legally marketed predicate devices. System supports fixed or removable dental prostheses.

Indications for Use

Indicated for patients requiring dental prostheses (single tooth, partially edentulous, or full arch) in upper or lower jaw arches. Includes option for immediate placement and function in the mandible for splinted multiple-unit restorations (minimum four implants) anterior to the mental foramen, provided good primary stability and appropriate occlusal loading are achieved.

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

• NSI Hexed and Non-Hexed Implant System (K003620)
• NSI Hexed and Non-Hexed Implant System (K020617)
• Innovative Implants and Cover Screws (K874590)
• Branemark System Zygomaticus Fixture System (K970499)
• Straumann USA Hollow Cylinder implant, 15° angled (K894593)
• Nobel Biocare Various Branemark System Dental Implant Products (K022562)
• Astra Dental Implants (K024111)
• Astra Dental Implants (K012965)
• ITI Straumann Dental Implant System (K030007)
• Friadent XiVE Transgingival Dental Implant System (K024004)

Submission Summary (Full Text)

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K033171

APR 2 7 2004

## 510(k) Summary

Name/Address of Submitter: Northern Implants, LLC. 10565 Lee Highway, Suite 100 Fairfax, VA 22030

Contact Person: Greta M. Hols Phone: [phone] Fax: [phone]

Date Summary Prepared: September 23, 2003

Device Name: Endosseous Implant and Accessories

Trade Name: NSI Hexed and Non-Hexed Implant System

- Purpose: The purpose of this 510(k) is to include additional implants and accessories in the NSI Hexed and Non-Hexed Endosseous Implant System (K003620) and K020617 that did not fall within the size range and design shapes identified in our original 510(k) submissions for our system. Additionally, it is to expand upon the intended usage to include the option for immediate loading.
## Predicate Devices:

K003620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System K874590 Innovative Implants and Cover Screws K970499 Branemark System Zygomaticus Fixture System K894593 Straumann USA Hollow Cylinder implant, 15° angled K022562 Nobel Biocare Various Branemark System Dental Implant Products K024111 and K012965 Astra Dental Implants K030007 ITI Straumann Dental Implant System K024004 Friadent XiVE Transgingival Dental Implant System

- Device Description and Intended Use: The NSI Implant System is intended for implantation in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multipleunit implant restorations anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.
- Technological Characteristics: The physical properties and designs of the additional implants and accessories in the NSI Hexed and Non-Hexed Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable.
- Brief Discussion of Clinical Studies: Clinical studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2004

Ms. Greta M. Hols Director of Operations Northern Implant, LLC 10565 Lee Highway Suite 100 Fairfax, Virginia, 22030

Re: K033171

Trade/Device Name: Endosseous Dental Implant System and Immediate Loading Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: February 5, 2004 Received: February 10, 2004

Dear Ms. Hols:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Hols

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Chih Lin, Ph.D.

Chiu Lin, Ph.D. 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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## Indication for Use

510(k) Number: K033171

Device Name: Endosseous Dental Implant System

Indication for Use: The NSI Implant System is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function in the mandible on splinted multiple-unit implant restorations supported by a minimum of four implants anterior to the mental foramen when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

## Concurrence of CDRH Office of Device Evaluation

Prescription Use
(Per 21 CFR801.109)

OR

Over-the-counter Use

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510(k) Number: K033171