THE GUIDED SURGERY CONCEPT

K050393 · Nobel Biocare AB · DZE · May 4, 2005 · Dental

Device Facts

• Record ID: K050393
• Device Name: THE GUIDED SURGERY CONCEPT
• Applicant: Nobel Biocare AB
• Product Code: DZE · Dental
• Decision Date: May 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Guided Surgery Concept is intended for the treatment of totally and partially edentulous jaws as well as single unit cases. The Guided Surgery Concept enables a predictable, fast and minimally invasive endosseous dental implant installation procedure according to case planning done by the clinician. The Guided Surgery Concept enables the final prosthesis to be produced prior to and attached in the same session as the implant installation. The entire procedure is typically completed within one hour and can be used for the treatment of totally and partial edentulous patients as well as patients missing a single tooth.

Device Story

System uses 3D planning software to process CT-scan data; clinician performs virtual case planning to determine implant location/orientation. Software output used to fabricate physical surgical template. Clinician uses template during surgery to guide site preparation and implant placement; enables immediate attachment of prefabricated temporary or final prosthesis. Procedure performed in clinical setting; typically completed within one hour. Benefits include predictable, fast, minimally invasive installation and immediate restoration of function/esthetics.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

System includes 3D planning software and surgical templates. Software processes CT-scan data for virtual surgical planning. Template acts as physical guide for implant site preparation and placement. No specific materials or connectivity standards provided.

Indications for Use

Indicated for treatment of single, partially, and totally edentulous jaws for placement of implant fixtures with immediate function to restore esthetics and chewing function. Prerequisites: adequate amount and quality of jaw bone.

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

• Teeth in an Hour - ARK Implant Concept (K030685)

Submission Summary (Full Text)

{0}------------------------------------------------

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

| Submitted by: | Elizabeth J. Mason<br>Sr. 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: | February 16, 2005 |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | The Guided Surgery Concept |
| Legally Marketed Device(s): | Teeth in an Hour - ARK Implant Concept (K030685) |

#### Device Description:

The Guided Surgery Concept is intended for the treatment of totally and partially edentulous jaws as well as single unit cases. The Guided Surgery Concept enables a predictable, fast and minimally invasive endosseous dental implant installation procedure according to case planning done by the clinician.

The Guided Surgery Concept enables the final prosthesis to be produced prior to and attached in the same session as the implant installation. The entire procedure is typically completed within one hour and can be used for the treatment of totally and partial edentulous patients as well as patients missing a single tooth.

The Guided Surgery Concept includes 3D Planning Software that enables the clinician to view threedimensional CT-scan data as well as to plan the case in a virtual three-dimensional environment. This case planning can be used to produce a Surgical Template, thus transferring the virtual case planning into physical tools enabling the surgical installation according to the virtual case planning.

The Guided Surgery Concept is based upon knowledge of the location and orientation of the implant(s) prior to the surgery. This knowledge enables the production of a Surgical Template. Aided by the Surgical Template, the sites can be prepared and the implants placed in the predetermined locations enabling the immediate attachment of the prefabricated temporary or final prosthesis.

### Indications for Use:

maled Surgery Concept and Teeth-in-an-Hour are indicated for the treatment of single, partially and totally edentulous jaws for placement of implant fixtures with immediate function to restore patient esthetics and chewing function. The following prerequisites must be fulfilled:

- adequate amount of jaw bone

- the quality of jaw bone must be judged as adequate

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 4 2005

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

Re: K050393

Trade/Device Name: The Guided Surgery Concept Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: February 16, 2005 Received: February 16, 2005

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 referenced above and in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 the Federal F 000, Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls pro riments 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 (1 Nr.), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device can be foundsh further announcements concerning your device in the Federal Register.

{2}------------------------------------------------

## Page 2 - Ms. Mason

Please be advised that FDA's issuance of a substantial equivalence determination does not Fleast be auvrsou mat 1 DTF o ibstains on that your device complies with other requirements mean that i DA mas made statutes and regulations administered by other Federal agencies. of the Act of ally I oderal statuse and equirements, including, but not limited to: registration r ou must compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and ilsuing (21 OF R Part 807), absitiss systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quadiation 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) I mis letter wrif anon your co bogan finding of substantial equivalence of your device to a premarket notified.com - I a 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), If you desire specific at 100 Tompliance 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 may overn other generational and Consumer Assistance at its toll-free Division [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clive

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

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known):

K050393

Device Name: The Guided Surgery Concept

Indications For Use:

The Guided Surgery Concept and Teeth-in-an-Hour are indicated for the treatment of single, partially and I he Guided Surgery Concept and 160th in the new with immediate function to restore patient esthetics and chewing function. The following prerequisites must be fulfilled.

- adequate amount of jaw bone

- the quality of jaw bone must be judged as adequate

× 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)

Rai Muley for HSR

on Sam-Gif vision of Anesthesiology, General Hospital, Intection Control, Dental Devices

Tick) Number

Page 1 of 1