NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM

K070857 · Nobel Biocare AB · DZE · Dec 28, 2007 · Dental

Device Facts

• Record ID: K070857
• Device Name: NOBELDIRECT 3.0-IMMEDIATE LOAD, 3.0 X 13 MM AND 3.0 X 15 MM
• Applicant: Nobel Biocare AB
• Product Code: DZE · Dental
• Decision Date: Dec 28, 2007
• 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. The NobelDirect 3.0 Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied. Mandible central and lateral incisors must be splinted if using two or more 3.0mm implants adjacent to one another.

Device Story

Threaded one-piece root form endosseous dental implant with integrated abutment; 3.0mm diameter; 13mm and 15mm lengths. Designed for one-stage surgical procedures to support prosthetic teeth. Used by dental clinicians in clinical settings to restore chewing function in partially edentulous patients. Implant provides structural foundation for artificial teeth; immediate loading permitted contingent upon specific stability criteria. Mandibular splinting required for adjacent implants to ensure stability.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use similarities to the predicate device.

Technological Characteristics

One-piece root form endosseous dental implant; integrated abutment; 3.0mm diameter; 13mm and 15mm lengths. Material and manufacturing specifications are consistent with the predicate NobelDirect system.

Indications for Use

Indicated for partially edentulous patients requiring treatment for missing maxillary lateral incisors or mandibular central and lateral incisors. Supports prosthetic devices to restore chewing function. Allows immediate function if stability requirements are met; mandibular central/lateral incisors require splinting if multiple 3.0mm implants are adjacent.

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

• NobelDirect (K031345)

Submission Summary (Full Text)

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K070857

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

| Submitted by: | Herbert Crane<br>Director, Global Regulatory Affairs | DEC 2 8 2007 |
|----------------------------------------|----------------------------------------------------------------------------|--------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 | |
| Telephone: | [phone], ext. 7830 | |
| Facsimile: | [phone] | |
| Date of Submission: | March 27, 2007 | |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) | |
| Trade or Proprietary<br>or Model Name: | NobelDirect 3.0 - Immediate Load | |
| Legally Marketed Device(s): | NobelDirect (K031345) | |

### Device Description:

Nobel Biocare's NobelDirect 3.0 Implant is a threaded one-piece root form endosseous implant with an integrated abutment designed for one-stage surgical procedures. The NobelDirect 3.0 is 3.0mm in diameter and available in lengths of 13mm and 15mm.

#### 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. The NobelDirect 3.0 Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" around the edge. In the center of the seal is an abstract image of an eagle.

DEC 2 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nobel Biocare AB C/O Ms. Phuong Nguyen Son Regulatory Affairs Specialist Nobel Biocare USA, Incorporated 22715 Savi Ranch Parkway Yorba Linda, California 92887

Re: K070857

Trade/Device Name: NobelDirect 3.0- Immediate Load Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 10, 2007 Received: December 11, 2007

Dear Ms. Son:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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 vour 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. Son

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 (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), 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/industry/support/index.html.

Sincerely yours.

Shule H. Murphy, MD

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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K070857

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# Indications for Use

510(k) Number (if known):

Device Name: NobelDirect 3.0 - Immediate Load

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. The NobelDirect 3.0 Implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

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

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)

Shule H. Murgatroy ho

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