TIUNITE IMPLANTS

K050705 · Nobel Biocare AB · DZE · May 19, 2005 · Dental

Device Facts

• Record ID: K050705
• Device Name: TIUNITE IMPLANTS
• Applicant: Nobel Biocare AB
• Product Code: DZE · Dental
• Decision Date: May 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nobel Biocare TiUnite® Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare TiUnite® Implants are indicated for single or multiple unit restorations in splinted applications. Nobel Biocare TiUnite® Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. TiUnite implants are indicated for use in soft bone whenever immediate or early loading is applied. The TiUnite implants are preferred in these soft bone indications because bone formation is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates.

Device Story

TiUnite Implants are threaded, root-form dental implants; machined from titanium with a titanium oxide surface layer. Placed in upper or lower jaw bone via single or two-stage surgical procedures; support prosthetic devices like artificial teeth. Surface treatment promotes rapid bone-to-implant contact; enhances osseointegration; maintains initial stability in soft bone. Used by dental surgeons in clinical settings. Output is a stable foundation for dental prosthetics; enables immediate or early loading protocols; improves success rates in soft bone compared to machined implants.

Clinical Evidence

No clinical data provided in the summary. Substantial equivalence is based on technological characteristics and performance comparisons to the predicate device.

Technological Characteristics

Root-form threaded dental implants; material: titanium with titanium oxide (TiUnite) surface layer. Available in straight or tapered contours. Designed for endosseous placement in jaw bone.

Indications for Use

Indicated for patients requiring single or multiple unit dental restorations in the upper or lower jaw. Suitable for immediate or early loading, particularly in soft bone, to restore esthetics and 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

• Nobel Biocare Endosseous Implants (K041661)

Submission Summary (Full Text)

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K050705

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

MAY 1 9 2005

| Submitted by: | Herbert Crane<br>Manager, Regulatory Affairs |
|----------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 5074 |
| Facsimile: | [phone] |
| Date of Submission: | March 18, 2005 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | TiUnite™ Implants |
| Legally Marketed Device(s): | Nobel Biocare Endosseous Implants (K041661) |

#### Device Description:

Nobel Biocare TiUnite" 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 patient esthetics and chewing function to partially or fully edentulous patients.

Til hite Implants machined from titanium and have a surface treatment consisting of a thin, uniform titanium oxide (TiUnite") layer. Nobel Biocare TiUnite Implants are available with a straight or tapered contour.

Nobel Biocare TiUnite" 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 where good initial stability can be obtained.

Due to a more rapid formation and greater amount of bone to implant contact during healing. Nobel Biocare's TiUnites surfaced implants result in faster and stronger ossecuntegration and better maintenance of the initial implant stability than machined titanium implants. When piaced in soft bone and immediately loaded, the faster and stronger osseointegration of Nobel Biocare's TiUnites surfaced implant results in a higher success rate compared to machined implants

### Indications for Use:

Nobel Biocare TiUnite® Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare TilUnite® Implants are indicated for single or multiple unit restorations in splinted applications. Nobel Biocare TiUnite® Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

TiUnite implants are indicated for use in soft bone whenever immediate or early loading is applied. The TiUnite implants are preferred in these soft bone indications because bone formation is more rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability. faster and stronger osseointegration, and higher success rates

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

MAY 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nobel Biocare AB C/O Mr. Herbert Crane Manager Regulatory Affairs Nobel Biocare USA, LLC 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K050705

Trade/Device Name: TiUnite® Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: March 17, 2005 Received: March 18, 2005

Dear Mr. Crane:

We have reviewed your Section 510(k) premarket notification of intent to market the device WE have reviewed your becares researce is substantially equivalent (for the referenced above and have determined are to tegally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate comments, or to that bay been reclassified in accordance with the forcement Amendinents, or to de vices that have obct (Act) that do not require approval of a prematice the Federal Food, Drug, and Cosment 1 10 ( 16) - 16) - 16, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 10, 1 approval application (1 Mr ). - Four my - Four - San - San - Sat include controls provisions of the rich - 110 gisting of devices, good manufacturing practice, requirements for animons against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see ass rolling controls. Existing major regulations affecting (PMA), it may of subject to Such adaments. Title 21, Parts 800 to 898. In the Cl., Parts 800 to 898. In your device can be found in the Oode of receined in the Federal Register.

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## Page 2 - Mr. Crane

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that IDA S Issualice of a babound. Vice complies with other requirements mean that FDA has made a decemmanent and regulations administered by other Federal agencies. of the Act of ally rederal statues and regulations, but not limited to: registration it You must comply with an the Het brequired (21 CFR Part 801); good manufacturing practice and ifsing (21 CFR Part 607), laceming (21 CFR Pat 820), regulation (21 CFR Part 820); and if requirements as set form in the quality brovisions (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 5 10(k) This letter will anow you to begin mailing of substantial equivalence of your device to a premarket notification. The PDA midness of bassification 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 Patt 801), If you desire specific advice for your do records on the Also, please note the regulation prease contact the Office of Ochiphants and entification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain other general miormation on and Consumer Assistance at its toll-free Division of Binas 2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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# Indications for Use

510(k) Number (if known):

Device Name: TiUnite® Implants

Indications For Use:

dications I of Or Obe.

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bone of the upper or lower jaw arches to proxtins . Nohol Rincere , such as bone of the upper or lower jaw arches to provide suppor Til bith Implants are indicated for order to restore patient esthetics and chewing function. Nobel Biocare Titlenter Intent malants
single or multiple unit restorations in splinted or non-splinted the intilal single or multiple unit restorations in splinted of nor-splined applications working the initial stability requirements
may be placed immediately and put into immediate funct may be place -----------------------------------------------------------------------------------------------------------------------------------------------------------------

TiUnite® implants are indicated for use in soft bone whenever immediate or early bading is applied. The TiUnite® implants are indicated for use in Sol bone indications because bone formation is more rapid and Tillnite® implants are preferred in these soft bother maintenance of initial implant stability, faster greater than on midonix.
and stronger osseointegration, and higher success rates.

Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR

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 Penn

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

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510(k) Number.