MONORAIL

K040143 · Nats Corp. · DZE · Sep 13, 2004 · Dental

Device Facts

• Record ID: K040143
• Device Name: MONORAIL
• Applicant: Nats Corp.
• Product Code: DZE · Dental
• Decision Date: Sep 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Monorail™ Endosseous Implant is intended for use as a self-tapping screw for transitional or intra-bony long-term support of any length of time as decided by the Health Care provider.

Device Story

Dentatus Monorail™ is an endosseous dental implant; functions as a self-tapping screw for bone fixation. Used by dental clinicians for transitional or long-term support of dental prosthetics. Device provides mechanical stability within the jawbone; supports various lengths of time based on clinical judgment. No electronic, software, or algorithmic components involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Endosseous dental implant; self-tapping screw design. Class II device (Product Code DZE). No software, electronics, or energy sources.

Indications for Use

Indicated for use as a self-tapping screw for transitional or intra-bony long-term support in patients requiring dental implant stabilization, as determined by a healthcare provider.

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.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 3 2004

Mr. Richard C. Lanzillotto NATS Corporation 30 Northport Road Sound Beach, New York 11789-1734

Re: K040143

Trade/Device Name: Dentatus Monorail™ Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 17, 2004 Received: June 29, 2004

Dear Ms. Lanzillotto:

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 approvisions 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 - Mr. Lanzillotto

Please be advised that FDA's issuance of a substantial equivalence determination does not I least be advised that 1 Dr. determination that your device complies with other requirements Incall that I DX mas made and regulations administered by other Federal agencies. of the Act of ally I oderal button as a requirements, including, but not limited to: registration Tourinust comply with and are labeling (21 CFR Part 801); good manufacturing practice alle fishing (21 CF Real voor), systems (QS) regulation (21 CFR Part 820); and if requirents as sot form nroduct 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) This letter will and n Jourse of Substantial equivalence of your device to a premarket notification - a 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 ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 may obtain 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,

Chiu 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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Dentatus Monorail™ Endosseous Implant 510K Notification

## INDICATIONS FOR USE

K040143 510(k) Number (if known):

Dentatus Monorail™ Device Name:

The Monorail™ Endosseous Implant is intended for use as a self-Indications for Use: The Nionoran screw for transitional or intra-bony long-term tupping thankin of any length of time as decided by the Health Care provider.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

:

(Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Dunn
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K040142

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