NOBEL BIOCARE ENDOSSEOUS IMPLANTS

K041661 · Nobel Biocare Uas, Inc. · DZE · Aug 26, 2004 · Dental

Device Facts

• Record ID: K041661
• Device Name: NOBEL BIOCARE ENDOSSEOUS IMPLANTS
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nobel Biocare Endosseous Implants are indicated for use as root form endosseous implants in partially or fully edentulous patients for the purpose of restoring chewing function. Implants may be tilted up to 45°. When used with angulations between 30° and 45°, the following applies: - the tilted implants must be splinted - a minium of four implants must be used when supporting a fixed prosthesis in a fully edentulous arch

Device Story

Nobel Biocare Endosseous Implants are threaded, root-form dental implants; machined from titanium; available in straight or tapered geometries. Surface configurations include hydroxyapatite (HA) coating, titanium oxide layer (TiUnite), or uncoated/untreated (Brånemark). Implants are surgically placed in the upper or lower jaw by dental professionals using single or two-stage procedures; immediate loading is permitted for single-stage procedures. Devices support prosthetic artificial teeth to restore chewing function in edentulous patients. Clinical benefit derived from restoring oral function and stability for prosthetic support.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium. Surface: HA coated, titanium oxide layer, or uncoated. Form factor: Threaded, root-form, straight or tapered. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for partially or fully edentulous patients requiring root form endosseous implants to restore chewing function. Implants may be placed in upper or lower jaw; tilted up to 45° (requires splinting if 30°-45°).

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

• Replace HA Coated Implants (K022424)
• Brånemark System Implants (K022562)
• Replace TiUnite Endosseous Implants (K023113)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness 1.4

| Submitted by: | Elizabeth J. Mason<br>Sr. Regulatory Affairs Specialist |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA Inc.<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | June 16, 2004 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | Nobel Biocare Endosseous Implants |
| Legally Marketed Device(s): | Replace HA Coated Implants (K022424)<br>Brånemark System Implants (K022562)<br>Replace TiUnite Endosseous Implants (K023113) |

Device Description:

Nobel Biocare Endosseous Implants are threaded, root-form dental implants intended for use in the upper and/or lower jaw to support prosthetic devices, such as artificial teeth, in order to restore chewing function to partially or fully edentulous patients.

Nobel Biocare Endosseous Implants are machined from titanium and available straight or tapered. The implants are either a) coated with hydroxyapatite powder, i.e. HA coated implants; b) have a surface treatment of the implant that consists of a titanium oxide layer, i.e. TiUnite implants; or c) do not have any coating or surface treatment, i.e. Branemark implants.

Nobel Biocare Endosseous Implants may be placed in the oral cavity using either a single stage surgical procedure or a two stage surgical procedure. If a single stage procedure is used, the implants may be immediately loaded following insertion. Nobel Biocare Endosseous Implants can be placed anywhere in the upper or lower jaw where good initial stability of the implant can be obtained.

Indications for Use:

Nobel Biocare Endosseous Implants are indicated for use as root form endosseous implants in partially or fully edentulous patients for the purpose of restoring chewing function. Implants may be tilted up to 45°. When used with angulations between 30° and 45°, tilted implants must be splinted.

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Image /page/1/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle, following its curvature. The logo is black and white and appears to be of moderate resolution.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 6 2004

Ms. Elizabeth J. Mason Senior Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K041661

Trade/Device Name: Nobel Biocare Endosseous Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: June 16, 2004 Received: June 22, 2004

Dear Ms. Mason:

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 - Ms. Mason

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 roquiceller as 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) rms reter 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), r you 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 Inter 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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K04166

510(k) Number (if known):

Device Name: Nobel Biocare Endosseous Implants

Indications For Use:

Nobel Biocare Endosseous Implants are indicated for use as root form endosseous implants in partially or fully edentulous patients for the purpose of restoring chewing function. Implants may be tilted up to 45°. When used with angulations between 30° and 45°, the following applies:

- · the tilted implants must be splinted
- · a minium of four implants must be used when supporting a fixed prosthesis in a fully edentulous arch

X 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 Runnr

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: