REPLACE TIUNITE ENDOSSEOUS IMPLANT

K023113 · Nobel Biocare Uas, Inc. · DZE · Sep 26, 2002 · Dental

Device Facts

• Record ID: K023113
• Device Name: REPLACE TIUNITE ENDOSSEOUS IMPLANT
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: DZE · Dental
• Decision Date: Sep 26, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nobel Biocare Replace TiUnite Endosseous Implant is intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure. If the single stage procedure is used, these implants may be loaded immediately following insertion -- provided -- at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.

Device Story

Replace TiUnite Endosseous Implant is a threaded root-form dental implant; available in various widths (3.5mm–6.0mm) and lengths (10mm–16mm). Features a titanium oxide surface layer (mean thickness <10μ). Implanted into upper or lower jaw by dental surgeons to support prosthetic teeth; restores chewing function. Supports two-stage or single-stage surgical protocols. Single-stage loading requires minimum four implants splinted with a bar in the anterior mandible to ensure stability. Device provides mechanical foundation for dental prosthetics.

Clinical Evidence

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

Technological Characteristics

Threaded root-form dental implant; titanium construction with a titanium oxide surface layer (mean thickness <10μ). Available in widths of 3.5mm, 4.3mm, 5.0mm, and 6.0mm; lengths of 10mm, 13mm, and 16mm. Mechanical fixation via surgical insertion into the jawbone.

Indications for Use

Indicated for patients requiring dental restoration in the upper or lower jaw to support prosthetic devices and restore chewing function. Suitable for two-stage or single-stage surgical procedures. Single-stage loading requires at least four implants splinted with a bar, placed predominantly in the anterior mandible between the mental foramina where good initial stability is achievable.

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

• Modified Surface Implant (K993595)

Submission Summary (Full Text)

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SEP 2 6 2002

K023113

510(k) Summary of Safety and Effectiveness

| Submitted by: | Herbert Crane, Manager Regulatory Affairs |
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| Address: | Nobel Biocare USA, Inc.<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone] x5074 |
| Fax: | [phone] |
| Date of Submission: | 18 Sept. 2002 |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | Replace TiUnite Endosseous Implant |
| Legally Marketed Device: | Modified Surface Implant (K993595) |

## Device Description:

The Replace TiUnite endosseous implant is a threaded root-form dental implant. It comes in widths of 3.5mm, 4.3mm, 5.0mm, and 6.0mm. Each width comes in lengths of 10mm, 13mm, and 16mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean<10μ).

### Indications for Use:

The Nobel Biocare Replace TiUnite Endosseous Implant is intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.

If the single stage procedure is used, these implants may be loaded immediately following insertion -- provided -- at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.

Nobel Biocare USA, Inc. 510(k) Notification Replace™ TiUnite Endosseous Implant September 2002

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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SEP 2 6 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Herbert Crane Manager, Regulatory Affairs Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K023113

Trade/Device Name: Replace TiUnite Endosseous Implant Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 18, 2002 Received: September 19, 2002

Dear Mr. Crane:

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.

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.

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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 (OS) 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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# 510(k) Number (if known): K023113

Device Name: Replace TiUnite Endosseous Implant

Indications For Use:

The Nobel Biocare Replace TiUnite Endosseous Implant is intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth, and to restore patient's chewing function. This may be accomplished using a two stage surgical procedure or a single stage surgical procedure.

If the single stage surgical procedure is used, these implants may be loaded immediately following insertion - provided - at least four implants are placed and splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foraminae) where good initial stability of the implants with or without bi-cortical anchorage, can most often be obtained.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rupp

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

510(k) Number:

(Optional Format 3-10-98)