MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9

K070022 · Mis Implants Technologies , Ltd. · DZE · Apr 20, 2007 · Dental

Device Facts

• Record ID: K070022
• Device Name: MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9
• Applicant: Mis Implants Technologies , Ltd.
• Product Code: DZE · Dental
• Decision Date: Apr 20, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mistral one stage screw-type dental implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

Device Story

Mistral is a one-stage, screw-type, internal octagon dental implant; used in surgical and restorative dentistry to support prosthetic devices (artificial teeth) in the upper or lower jaw. Implant provides foundation for tooth replacement to restore chewing function. Device is placed by dental professionals. Surface treatment involves sandblasting and acid etching to enhance bone contact.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: Medical grade 5 titanium (ASTM F136). Design: One-stage, screw-type, internal octagon. Dimensions: Diameters 3.75, 4.10, 4.80 mm; Lengths 8, 10, 11.50, 13, 16 mm. Surface: Sandblasted and acid-etched for increased bone contact.

Indications for Use

Indicated for patients requiring dental implants in the upper or lower jaw to support prosthetic devices and restore chewing function.

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

• One stage implant as part of MIS Dental Implant System (K040807)

Submission Summary (Full Text)

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K070022

Image /page/0/Picture/1 description: The image shows the word "mis" in a stylized font. The letters are connected and have a rounded appearance. The "i" in "mis" is a simple vertical line with a dot above it, and the "s" is a curved shape.

APR 2 0 2007

510(k) Summary: Mistral one stage screw-type dental implant

Company Name: MIS Implant Technologies Ltd.

# Contact Person:

Iman Khorshid Quality Manager Telephone: [phone] [phone] Fax: E-mail: [e-mail]

### Authorized US Agent:

Motti Weisman - VP Marketing MIS Implants Technologies Inc. 278 Broadway Elmwood Park, NJ 07407

Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date prepared: October 26, 2006

Trade Name:

Mistral One Stage Screw-type Dental Implant

#### Classification:

Classification name: Endosseous Dental Implant Common/usual name: Endosseous Dental Implant Product Code: DZE Regulation No .: 872.3640 Class: II Panel identification: Dental Devices Panel

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# Predicate Device:

One stage implant as part of MIS Dental Implant System, MIS Implant Technologies, Shlomi, Israel, cleared under 510(k) no. K040807.

#### Description of the device:

The Mistral is a one stage, screw-type, internal octagon dental implant and is provided in the following range of dimensions:

- Diameters: 3.75. 4.10 and 4.80 mm -
- -Length: 8, 10, 11.50, 13 and 16 mm

All implants are manufactured from medical grade 5 pure titanium, which meets requirements of standard ASTM F136.

The required surface roughness and microgeometry of the implants is achieved by blasting sand particles and acid etching. Blasted surfaces archive more bone contact with the implant surface.

#### Indications for Use:

The Mistral one stage screw-type dental implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

#### Substantial Equivalence:

The Mistral single stage screw-type dental implant has the same intended use as the original one stage implant, cleared as part of the MIS dental Implant System under 510(k) no. K040807 and has equivalent performance characteristics. It is therefore substantially equivalent to that device.

#### Conclusion:

The evaluation of the Mistral single stage screw-type dental implant does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 0 2007

MIS Implant Technologies, Limited C/O Mr. Motti Weisman Vice President Marketing 278 Broadway Elmwood Park, New Jersey 07407

Re: K070022

Trade/Device Name: Mistral One Stage Screw-Type Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: April 9, 2007 Received: April 19, 2007

Dear Mr. Weisman:

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.

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Page 2 -Mr. Weisman

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/industry/support/index.html.

Sincerely yours,

Syrita Y. Michau Oms

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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# Indications for Use

510(k) Number (if known):

Device Name: Mistral one stage screw-type dental implant

Indications For Use:

The Mistral one stage screw-type dental implant is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function.

Prescription Use ﮯ (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suse Rusr

CONDICION Conars trol, Dema. Devilo

510(k) Number: K072020

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