ENDOSSEOUS DENTAL IMPLANT SYSTEM

K052490 · Northern Implants, LLC · DZE · Dec 8, 2005 · Dental

Device Facts

• Record ID: K052490
• Device Name: ENDOSSEOUS DENTAL IMPLANT SYSTEM
• Applicant: Northern Implants, LLC
• Product Code: DZE · Dental
• Decision Date: Dec 8, 2005
• 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 on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment.

Device Story

NSI Hexed and Non-Hexed Endosseous Implant System consists of screw-type dental implants and abutments. Used by dental professionals in clinical settings to support fixed or removable dental prostheses. Implants are surgically placed into the upper or lower jaw to restore chewing function. System allows for immediate placement and function for single or splinted multiple unit restorations, provided primary stability and proper occlusal loading are achieved. Device output is the physical support structure for dental prostheses. Benefits include restoration of oral function and aesthetics for edentulous patients. Not for use with angled abutments.

Clinical Evidence

No clinical studies were conducted or deemed necessary. Evidence consists of bench testing, specifically fatigue testing performed in accordance with the FDA Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Abutments (May 12, 2004).

Technological Characteristics

Screw-type endosseous dental implants and abutments. Materials: ASTM F67-95 Grade III or Grade IV Titanium. Design includes hexed and non-hexed configurations. Sterilization method not specified. No software or electronic components.

Indications for Use

Indicated for patients requiring dental prostheses (single tooth, partially edentulous, or full arch) in the upper or lower jaw. Supports immediate placement and function if primary stability and appropriate occlusal loading are achieved. Contraindicated for use with angled abutments.

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)
• NSI Hexed and Non-Hexed Implant System (K033171)
• Branemark System Zygomatic Implant (K970499)
• ITI Straumann's Angled Hollow Cylinder Implant (K894593)

Submission Summary (Full Text)

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K052490

## DEC 8 8 2005 510(k) Premarket Notification Summary

Name/Address of Submitter: Northern Implants, LLC 10355 B Democracy Lane Fairfax, VA 22030

Establishment Registration Number: 3003845138

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

Date Summary Prepared: Monday, August 29, 2005

Device Classification Name: Endosseous Implant and Accessories

Device Classification Regulation Number: 21 CFR 872.3640

Device Regulatory Status: Class II Special Controls

Trade Name: Endosseous Dental Implant

- Purpose: The purpose of this 510(k) is to include additional implants and accessories in the NSI Hexed and Non-Hexed Endosseous Implant System that did not fall within the size range and design shapes identified in prior 510(k) submissions for our system.
- Performance Standards: FDA has not established a performance standard applicable to endosseous implants and their accessories. The materials in the NSI Hexed Implant System meet applicable voluntary standards. Northern Implant's screw-type implants and abutments are manufactured from ASTM F67-95 Grade III or Grade IV Titanium.
- Predicate Devices: K003620 NSI Hexed and Non-Hexed Implant System K020617 NSI Hexed and Non-Hexed Implant System K033171 NSI Hexed and Non-Hexed Implant System K970499 Branemark System Zygomatic Implant K894593 ITI Straumann's Angled Hollow Cylinder Implant
- Device Description and Intended Use: The NSI Implant System is intended 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 on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function.

This implant is not intended, nor should it be used, in conjunction with an angled abutment.

- 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.
- Brief Discussion of Engineering Studies: Fatigue Testing was conducted per FDA Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental

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Abutments that was issued on May 12, 2004. Modification to the testing protocol were discussed Abuments that was issued on May 12, 2004: Mountoation to the toomig possible screw joint at With the FDA prior to conducting the lost (Bholosare of). Timbers was also conducted (Enclosure 10).

- Conclusions Drawn: The NSI Hexed and Non-Hexed Implant System has the same intended use as, and lons Drawn. The NST Heach and Non-Honou migrant of edicate devices. Any differences in the technological characteristics did not raise new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes above a wave-like form.

Public Health Service

2005 DEC 8

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Greta M. Hols Director Northern Implants, LLC 10355 B Democracy Lane Fairfax, Virginia 22030

Re: K052490

Trade/Device Name: Endosseous Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: August 29, 2005 Received: September 12, 2005

Dear Ms. Hols :

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becareermined 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinents, or to de rood that is Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include condors provisions of aregistration, 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 (1 Wri), it har be babyers to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be rounder 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 I Teast be advisod that I Dr. o looking that your device complies with other requirements modi that I Dr mas made statutes and regulations administered by other Federal agencies. or the Act of any I oderal twe Act's requirements, including, but not limited to: registration r ou intest comply with and 07); labeling (21 CFR Part 801); good manufacturing practice in allu listing (21 OF RT rate 007), labality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadiation 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) I mis letter will and n you to ongineers 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), If you desire specific at the compliance at [phone]. Also, please note the regulation picase contact the Office or Somplain notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may other 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/industry/support/index.html.

Sincerely yours,

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

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## Indication for Use

510(k) Number:

Device Name: Endosseous Dental Implant System

Indication for Use: The NSI Implant System is intended to be implanted in the upper Intercation for OSC. The NOT miptal.o Fremovable dental prostheses in a
or lower jaw arches to provide support for fixed or removable dental prostheses in a of 10wel Jaw alches to provide buppostheses, or full arch prostheses. It further adds the single tooth, partially odentatest and function on single and splinted multiple unit option for immediate placement anbility is achieved and with appropriate occlusal loading, to restore chewing function.

This implant is not intended, nor should it be used, in conjunction with an angled abutment.

## Concurrence of CDRH Office of Device Evaluation

Prescription Use_

OR

Over-the-counter Use

Syndicagen

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Financial. Digital. Devices

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(Per 21 CFR801.109)