NOBELDIRECT OD IMPLANT

K041876 · Nobel Biocare Uas, Inc. · DZE · Aug 20, 2004 · Dental

Device Facts

• Record ID: K041876
• Device Name: NOBELDIRECT OD IMPLANT
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 20, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NobelDirect™ OD Implant is a root form endosseous implant intended to provide immediate retention for removable tissue supported lower dentures in fully edentulous patients.

Device Story

Threaded one-piece root form endosseous implant; integrated ball attachment; designed for one-stage surgical procedures. Input: surgical site in anterior mandible. Operation: implant placed in edentulous arch; primary stability required for immediate function. Output: immediate retention for removable tissue-supported lower overdentures. Used in clinical dental settings by dentists/oral surgeons. Benefits: immediate stabilization of overdentures for fully edentulous patients. Utilizes Gold Cap for Ball Attachment.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use comparisons.

Technological Characteristics

Machined titanium; TiUnite titanium oxide surface treatment; one-piece design with integrated ball attachment; straight or tapered contour; endosseous root form; non-sterile (implied by surgical use); no software or electronic components.

Indications for Use

Indicated for fully edentulous patients requiring immediate retention for removable tissue-supported lower overdentures in the anterior mandible.

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

• Brånemark System Implants (K022562)
• Replace One-Piece Implants (K023952)

Submission Summary (Full Text)

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K041876

## AUG 2 0 2004

## 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: | July 9, 2004 |
| Classification Name: | Endosseous Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | NobelDirect™ OD Implant |
| Legally Marketed Device(s): | Brånemark System Implants (K022562)<br>Replace One-Piece Implants (K023952) |

## Device Description:

്ക് Nobel Biocare's NobelDirect™ OD Implant is a threaded one-piece root form endossions with an integrated ball attachment designed for one-stage surgical procedures and overdenture restorations. The integratou ball attablimont as intended to provide immediate retention for removable tissue supported lower overdentures in fully edentulous jaws.

Nobel Biocare's NobelDirect™ OD Implant can be placed in an edentulous arch or piaced simultaneously Nobel Diocare 3 Nobel Biocare's Nobel Biocare's NobelDirect™ OD Implant in immediate function applications, it is essential to obtain primary implant stability. Nobel Biocare's Gold Cap for Ball Attachment is to be utilized with the NobelDirect™ OD Implant.

Nobel Biocare's NobelDirect™ OD Implant is machined from titanium and is available with a straight or tapered contour. The NobelDirect™ OD Implant has a surface treatment that consists of a titanium oxide layer (TiUnite) that extends over the implant threads and onto the implant collar.

Indications for Use:

The NobelDirect™ OD Implant is a root form endosseous implant intended to provide immediate retention for removable tissue supported lower dentures in fully edentulous patients.

000009

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that represent the wings and body of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2004

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

Re: K041876

Trade/Device Name: NobelDirect™ OD Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: July 9, 2004 Received: July 21, 2004

Dear Ms. Mason:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) promised is substantially equivalent (for the referenced above and have determined are to legally marketed predicate devices marketed in indications for use stated in the encreating of the enactment date of the Medical Device interstate conments, or to thay 20, 1778, and the same with the provisions of Amendments, of to devices that have occi. Toot) that do not require approval of a premarket the Federal Pood, Drug, and Cosmette Por (recefore, subject to the general approval appreation (1 Mr.). Tou sees, controls provisions of the Act include controls provisions of the Fiel. "The ginners of devices, good manufacturing practice, requirements for nibitions 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 above) into enotrels. Existing major regulations affecting (PMA), II may be subject to Sach additional Prairies of Parts 800 to 898. In your device can be found in the Code of Pecements 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 Please be advised that IDA S Issuance of a substantes with other requirements
mean that FDA has made a determination that your device Federal agencies mean that FDA has made a decermination that no administered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by powired to of the Act or any rederal statues and reguirements, including, but not limited to: registration
You must comply with all the Act's requirements . . . . . . . . . . . . . . . You must comply with an the Act 3 requirements and 801); good manufacturing practice
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Fart 807), labeling (21 CFR Part 820); and if requirements as set form in the quality systems (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) This letter will anow you to begin manceant 7 500 stantial equivalence of your device to a premarket notification. THC I DA miaing or 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 Part 801), a If you desire specific advice for your deries of the street. Also, please note the regulation please contact the Other or Comphanes and (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain offer general information on Jour Capper Assistance at its toll-free DIVIsion of Sman Manata [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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## Indications for Use

510(k) Number (if known):

KO41876

Device Name: NobelDirect'" OD Implant

Indications For Use:

The NobelDirect™ OD Implant is a root form endosseous implant intended to provide ime NobelDiroot - OB Thiplantes of Supported overdenture. The NobelDirect™ immediate fotorkion for a foraminal area of the anterior mandible for the fully edentulous lower 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)

Swam Purna

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

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510(k) Number. K091862