NOBELREPLACE TAPERED CONICAL CONNECTION

K062566 · Nobel Biocare USA, LLC · DZE · Dec 6, 2006 · Dental

Device Facts

• Record ID: K062566
• Device Name: NOBELREPLACE TAPERED CONICAL CONNECTION
• Applicant: Nobel Biocare USA, LLC
• Product Code: DZE · Dental
• Decision Date: Dec 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Nobel Biocare's NobelReplace Tapered Conical Connection implants are endosseous dental 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. The NobelReplace Tapered Conical Connection implants are indicated for single or multiple unit restorations. The NobelReplace Tapered Conical Connection implants can be used in splinted or nonsplinted applications. The NobelReplace Tapered Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Device Story

Threaded, root-form endosseous dental implants; machined from commercially pure titanium (grade 4); feature tapered body contour, collar/thread grooves, and TiUnite surface treatment. Surgically placed in jaw bone by dental professionals to support prosthetic artificial teeth. Internal conical connection design allows compatibility with specific abutments. Restores patient esthetics and chewing function; supports single/multiple unit, splinted/nonsplinted restorations. Immediate placement and function possible upon meeting stability requirements.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Commercially pure titanium (grade 4); tapered body geometry; TiUnite surface treatment; internal conical connection; threaded root-form design.

Indications for Use

Indicated for partially or fully edentulous patients requiring single or multiple unit restorations in upper or lower jaw arches; supports prosthetic devices to restore esthetics and chewing function; suitable for immediate placement and function if initial stability criteria are met.

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

• Groovy Implants (K050258)
• SFB & CFB Implants (K061003)

Submission Summary (Full Text)

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K062566

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

DEC - 6 2006

| Submitted by: | Ms. Phuong Nguyen Son<br>Regulatory Affairs Specialist |
|----------------------------------------|----------------------------------------------------------------------------|
| Address: | Nobel Biocare USA LLC<br>22715 Savi Ranch Parkway<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | August 30, 2006 |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | NobelReplace Tapered Conical Connection |
| Legally Marketed Device(s): | Groovy Implants (K050258)<br>SFB & CFB Implants (K061003) |

## Device Description:

Nobel Biocare's NobelReplace Tapered Conical Connection implants are threaded, root-form dental implants intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients.

The NobelReplace Tapered Conical Connection implants are similar in design to the NobelReplace Tapered implants cleared under "Groovy Implants" (K050258). Like the NobelReplace Tapered implant, the NobelReplace Tapered Conical Connection implant is machined from commercially pure titanium, grade 4, have a tapered body contour, grooves on the collar, grooves on the threads of the body, and a TiUnite surface treatment. The difference between the two implants is that the NobelReplace Tapered Conical Connection implants have the same internal connection as the SFB implants, cleared under "SFB & CFB Implants"(K061003). The internal conical connection allows for the use of SFB abutments.

### Indications for Use:

Nobel Biocare's NobelReplace Tapered Conical Connection implants are endosseous dental 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. The NobelReplace Tapered Conical Connection implants are indicated for single or multiple unit restorations. The NobelReplace Tapered Conical Connection implants can be used in splinted or nonsplinted applications. The NobelReplace Tapered Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 2006

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

Re: K062566

Trade/Device Name: NobelReplace Tapered Conical Connection Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: November 22, 2006 Received: November 24, 2006

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.

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#### Page 2 - Mr. Crane

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 vour 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,

Suette y. h, okum Omd.

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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K062566

# Indications for Use

K062566 510(k) Number (if known):

Device Name: NobelReplace Tapered Conical Connection

Indications For Use:

Nobel Biocare's NobelReplace Tapered Conical Connection implants are endosseous dental 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. The NobelReplace Tapered Conical Connection implants are indicated for single or multiple unit restorations. The NobelReplace Tapered Conical Connection implants can be used in splinted or non-splinted applications. The NobelReplace Tapered Conical Connection implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

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)

Sura Romer

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