NOBEL DIRECT, MODELS 30937, 30938

K031345 · Nobel Biocare Uas, Inc. · DZE · Jul 24, 2003 · Dental

Device Facts

• Record ID: K031345
• Device Name: NOBEL DIRECT, MODELS 30937, 30938
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: DZE · Dental
• Decision Date: Jul 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Device Story

Nobel Direct is an endosseous dental implant system; functions as a one-piece implant/abutment unit placed into bone to support prosthetic teeth. Device is a modification of the predicate Replace One Piece Implant (K023952), adding a 3.0mm diameter option. Used by dental clinicians to restore chewing function in patients with specific missing incisors. 3.0mm diameter implants are restricted to maxillary lateral or mandibular central/lateral incisor positions; available in 13mm and 15mm lengths. Mandibular placement requires splinting if multiple 3.0mm implants are used adjacently. Device provides structural support for dental prosthetics.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarity to the predicate device.

Technological Characteristics

Endosseous dental implant; one-piece implant/abutment design. Materials and fundamental design are identical to the predicate device (K023952). Available in 3.0mm diameter with 13mm and 15mm lengths. Intended for surgical placement in maxillary/mandibular bone.

Indications for Use

Indicated for partially edentulous patients requiring replacement of missing maxillary lateral incisors or mandibular central and lateral incisors to support prosthetic artificial teeth.

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® One Piece Implant (K023952)

Submission Summary (Full Text)

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JUL 2 4 2003

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# 510(k) Summary of Safety and Effectiveness

| Submitted by: | Elizabeth J. Mason, 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: | April 28, 2003 |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Trade or Proprietaryor Model Name: | Nobel Direct |
| Legally Marketed Device: | Replace® One Piece Implant (K023952)<br>(also known as > Nobel Direct) |

## Device Description:

Nobel Biocare's Nobel Direct is a name change of the legally marketed device "Replace" One Piece Implant" (K023952).

Nobel Biocare's Nobel Direct utilizes the same material and fundamental design as the unmodified, predicate device, "Replace" One Piece Implant" (K023952).

Nobel Biocare's Nobel Direct incorporates a design modification by adding an endosseous implant with a diameter of 3.0mm to the existing diameter sizes already in the Nobel Direct product line.

The Nobel Direct 3.0mm implant is restricted for use only in the maxillary lateral position or the mandibular central and lateral incisor position. The Nobel Direct 3.0mm implant/abutment is only available in lengths of 13mm and 15mm. The implant represent the portion of the unit placed in the bone (i.e. threaded portion).

### Indications for Use:

The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three people, with the person in the front reaching out to the other two.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 2003

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

Re: K031345

Trade/Device Name: Nobel Direct Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: DZE Product Code: III Dated: April 28, 2003 Received: April 29, 2003

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 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), please 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 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.

Sincerely yours/

fer

Susan Runner, DDDS, MA Interim 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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#### Statement of Indications for Use 1.3

Page 1 of 1

510(k) number (if known):

'4031345

Device Name: Nobel Direct

Indications for Use:

morought for 2001
The Nobel Direct 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients.

Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

(Please do not write below this line - Continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R.Beitz, DDS for Dr. K. Mulry

510(k) N

(Optional Format 3-10-98)