MYTIS ARROW XXXX

K052254 · Brainbase Corporation · DZE · Jun 1, 2006 · Dental

Device Facts

• Record ID: K052254
• Device Name: MYTIS ARROW XXXX
• Applicant: Brainbase Corporation
• Product Code: DZE · Dental
• Decision Date: Jun 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Mytis Implant Systems are intended for immediate placement in partially or fully edentulous mandibles and maxillae (type 1 or II bone), in support of single or multiple-unit restorations including, cement retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework.

Device Story

Mytis Arrow Implant System consists of root-form endosseous dental implants and compatible abutments. Designed for dental implant surgery; used in single or two-stage surgical procedures. Implants integrate with bone to support dental restorations. Used by dental professionals in clinical settings. Provides structural foundation for cement-retained, screw-retained, or over-denture restorations and fixed bridgework. Benefits patients by restoring oral function and aesthetics in edentulous sites.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Root-form endosseous dental implants and abutments. Designed for osseointegration. Materials and dimensions consistent with standard dental implant systems. No software or electronic components.

Indications for Use

Indicated for patients with partially or fully edentulous mandibles and maxillae (type 1 or II bone) requiring single or multiple-unit restorations, including cement-retained, screw-retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework.

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

• Branemark Implants (K022562)
• Branemark Implants (K993595)
• 3i Dental Implant Systems (K022113)
• 3i Dental Implant Systems (K022009)

Submission Summary (Full Text)

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K05 2254

JUN - 1 2006

510(k) Summary of Safety and Effectiveness (As Required by 21 C.F.R. §807.92)

Brainbase Corporation Applicant: Yoneyama 2nd Bldg 6F, 22-13 Oi 1-chome, Shinagawa-ku Tokyo, Japan 140-0014

Hiromi Shiojiri Contact Person: Phone [phone] Fax [phone] e-mail: [e-mail]

July 26, 2005 Date of summary Device name Mytis Arrow Implant Systems

Common name Endosscous Implant and Endosseous Dental Implant Abutment

| Classification names | Regulation Number | Product Code |
|----------------------|-------------------|----------------|
| | 21 CFR 872.3640 | DZE (Implant) |
| | 21 CFR 872.3630 | HNA (Abutment) |

Device Description The Mytis Arrow Implant system comprises various sets of root form endosseous dental implants and compatible implant abutment systems. Mytis Arrow Systems are designed for use in dental implant surgery and are intended to be used in a manor in which the implant integrates with the bone. The Mytis Arrow abutments include various abutments designed to enable the implant process from healing through final restoration. Mytis implants are for single and two-stage surgical procedures.

The device is substantially equivalent to other legally marketed Predicate Device devices in the United States including Branemark Implants (K022562 & K993595) and 3i Dental Implant Systems (K022113 & K022009).

Intended Use - Mytis Implant Systems are intended for immediate placement in partially or fully edentulous mandibles and maxillae (type 1 or II bone), in support of single or multiple-unit restorations including, cement retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework.

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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 features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 1 2006

Brainbase Corporation C/O Mr. Craig R. Bruns Law Office of Craig Bruns 10 Montecito Drive Danville, California 94526

Re: K052254

Trade/Device Name: Mytis Arrow XXXX Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE, NHA Dated: May 24, 2006 Received: May 30, 2006

Dear Mr. Bruns:

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. Bruns

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,

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: K052254

Device Name: Mytis Anow XXXX

Indications For Use:

Mytis Arrow XXXX systems are intended for immediate placement in extraction or surgically prepared sites in partially or fully edentulous mandibles and maxillae (type 1 or II bone), in support of single or multiple-unit restorations including; cement retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

1 3.43-Off of Anesthesiology, General Hospital, :on Control, Dental Devices

Number: KG52231

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