NSI HEXED AND NON-HEXED IMPLANT SYSTEM

K020617 · Nsi · DZE · May 10, 2002 · Dental

Device Facts

• Record ID: K020617
• Device Name: NSI HEXED AND NON-HEXED IMPLANT SYSTEM
• Applicant: Nsi
• Product Code: DZE · Dental
• Decision Date: May 10, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

NSI Hexed and Non-Hexed Implant System consists of endosseous dental implants and accessories; designed for surgical implantation into upper or lower jaw arches. Device provides structural support for fixed or removable dental prostheses; used for single tooth, partially edentulous, or full arch restoration. System is utilized by dental professionals in clinical settings. Implants integrate with bone to anchor prosthetic components, facilitating oral rehabilitation and restoring masticatory function.

Clinical Evidence

No clinical data was conducted or deemed necessary for this submission; bench testing only.

Technological Characteristics

Endosseous dental implants and accessories. Physical properties and designs are comparable to legally marketed predicate devices. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring dental prostheses support in the upper or lower jaw, including single tooth, partially edentulous, or full arch cases.

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)
• Restore Self-Tapping Dental Implant System (K951111)
• Restore Self-Tapping Dental Implant System (K944068)
• Innovative Implants and Cover Screws (K874590)
• Bonefit Hollow Screw Implants (K894594)
• Branemark System Gold Cylinders and Screws (K925773)
• Replace TPS Coated Implant (K002475)
• Branemark Systems Abutments Complete (K925769)
• Branemark System Etheticone Abutment Complete (K925777)

Submission Summary (Full Text)

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### 510(k) Summary

Name/Address of Submitter: NS1, Inc. 10565 Lee Highway, Suite 100 Fairfax. VA 22030

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

Fax: [phone]

Date Summary Prepared: February 22, 2002

Device Name: Endosseous Implant and Accessories

Trade Name: NSI Hexed and Non-Hexed Implant System

- Purpose: The purpose of this supplemental 510(k) is to include additional implants and accessories in the NSI Hexed and Non-Hexed Endosseous Implant System (K003620) that did not fall within the size range and design shapes identified in our original 510(k) submission for our system.
Predicate Devices: K003620 NSI Hexed and Non-IIexed Implant System K951111 Restore Self-Tapping Dental Implant System K944068 Restore Self-Tapping Dental Implant System K874590 Innovative Implants and Cover Screws K894594 Bonefit Hollow Screw Implants K925773 Branemark System Gold Cylinders and Screws K002475 Replace TPS Coated Implant K925769 Branemark Systems Abutments Complete · K925777 Branemark System Etheticone Abutment Complete

- Device Description and Intended 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
- 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.
- Conclusions Drawn: The NSI Hexed and Non-Hexcd Implant System has the same intended use as, and technological characteristics similar to, the legally marketed predicate devices. Any differences in the technological characteristics did not raise new issues of safety or effectiveness.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 1 0 2002

Ms. Greta M. Hols NSI 10565 Lee Highway, Suite 100 Fairfax, Virginia 22030

Re: K020617

Trade/Device Name: NSI Hexed and Non-Hexed Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: February 22, 2002 Received: February 25, 2002

Dear Ms. Hols:

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.

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.

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.

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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Susan Kunner

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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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 or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses.

·Concurrence of CDRH Office of Device Evaluation

Prescription Use
(Per 21 CFR801.109)

OR

Over-the-counter Use _________________________________________________________________________________________________________________________________________________________

MCClellan for MSR

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number __