BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM

K970499 · Nobel Biocare Uas, Inc. · DZE · Oct 16, 1997 · Dental

Device Facts

• Record ID: K970499
• Device Name: BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: DZE · Dental
• Decision Date: Oct 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nobel Biocare Brånemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.

Device Story

The Brånemark System Zygomaticus Fixture System is an endosseous dental implant system. It consists of titanium fixtures, drills, hand instruments, cover screws, and accessories. The system is surgically placed into the upper jaw arch by a clinician to provide a stable foundation for prosthetic devices, such as artificial teeth. By anchoring the prosthesis, the device restores the patient's chewing function. The system is used in a clinical setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and design similarity to legally marketed predicate devices.

Technological Characteristics

Endosseous dental implant system constructed of titanium. Components include fixtures, drills, hand instruments, and cover screws. The system is designed for surgical placement in the upper jaw.

Indications for Use

Indicated for patients requiring endosseous dental implants in the upper jaw arch to support prosthetic devices (artificial teeth) 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

• Fixtures (K925762)
• Drills (K925770)
• Fixture Mount (K925775)
• Cover Screws (K925771)
• Hand Instruments (K925774)
• Hand Instruments (K925483)
• Tray (K953774)
• Drill Guide (K951510)

Submission Summary (Full Text)

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K970499
OCT 16 1997

Pre-market Notification
February 6, 1997
Page -3-

## VII. 510(k) Summary of Safety and Effectiveness

### A. Name and Address

This Summary of Safety and Effectiveness is being submitted by Nobel Biocare USA, Inc., 777 Oakmont Lane, Suite 100, Westmont, IL 60559. Their telephone number is: [phone], extension 2002, and the contact person will be Betsy Brown, the Director, Regulatory Affairs.

### B. Name of the Device

This device consists of fixtures and numerous components to be used in conjunction with the BRÅNEMARK SYSTEM® Zygomaticus Fixture System, including Fixtures, Drills, Hand Instruments, Cover Screws and accessories specific to the Zygomaticus Fixture System.

### C. The Predicate Product

The predicate products used in this Premarket Notification are other components marketed by Nobel Biocare including the Fixtures, K925762, Drills, K925770, Fixture Mount, K925775, Cover Screws, K925771, and Hand Instruments, K925774, K925483 and a tray, K953774. The predicate products also include a Drill Guide, K951510 which is manufactured by Ace Surgical Supply Co.

### D. Description of the Device

The Nobel Biocare BRÅNEMARK SYSTEM® Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover screws and accessories.

### E. Intended Use of the Device

The Nobel Biocare BRÅNEMARK SYSTEM® Zygomaticus Fixture System is intended to be used as an endosseous implant to be surgically placed in the upper jaw to support prosthetic devices such as artificial teeth and to restore a patient's chewing function.

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Pre-market Notification
February 6, 1997
Page -4-

## F. Comparison of Technological Characteristics

The technological characteristics between the components of Zygomaticus Fixture System and the corresponding predicate products, comparable components in the BRÄNEMARK SYSTEM® and the drill guide manufactured by Ace Surgical Supply Co. are identical.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Ms. Betsy A. Brown
Vice President, Regulatory Affairs
Nobel Biocare USA, Incorporated
777 Oakmont Lane, Suite 100
Westmont, Illinois 60559

OCT 16 1997

Re: K970499
Trade Name: Branemark System Zygomaticus Fixture System
Regulatory Class: III
Product Code: DZE
Dated: July 18, 1997
Received: July 23, 1997

Dear Ms. Brown:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Brown

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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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510(k) Number (if known): _________________________

Device Name: Zygomaticus Fixture System

## Indications For Use:

The Nobel Biocare Brånemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runse

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number KA70491

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)