TEETH IN AN HOUR - ARK IMPLANT CONCEPT

K030685 · Nobel Biocare AB · DZE · Feb 6, 2004 · Dental

Device Facts

• Record ID: K030685
• Device Name: TEETH IN AN HOUR - ARK IMPLANT CONCEPT
• Applicant: Nobel Biocare AB
• Product Code: DZE · Dental
• Decision Date: Feb 6, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Teeth in an Hour - ARK Implant System is indicated for the treatment of totally edentulous jaws for placement of implant fixtures with immediate load function to restore the patient's chewing function. The following prerequisites must be fulfilled: - adequate amount of jaw bone - the quality of jaw bone must be judged as adequate - capability to open the mouth at least 50mm (this is especially important for lower jaws with the opposite jaw)

Device Story

System uses pre-operative modeling of patient jaw to determine implant placement; surgical template created with embedded cylinders and sleeves. During surgery, template positioned in patient mouth using anchor pins; osteotomies created through template sleeves. Implants placed into jaw; pre-produced prosthetic reconstruction attached immediately. Used in clinical dental settings by trained clinicians. Facilitates immediate loading of implants; reduces surgical complexity; restores patient chewing function.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and design similarities to predicate devices.

Technological Characteristics

Surgical template composed of acrylic material with embedded metal cylinders and sleeves. System utilizes standard endosseous dental implants. No electronic components, software, or energy sources involved. Sterilization of surgical components required.

Indications for Use

Indicated for totally edentulous patients requiring dental implant fixtures with immediate load function to restore chewing. Prerequisites: adequate jaw bone volume and quality; minimum 50mm mouth opening capability.

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

• Branemark Novum (K000018)
• Branemark System Implants - Immediate Function Indication (K022562)

Submission Summary (Full Text)

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FEB - 6 2004

KD30685

#### 510(k) Summary of Safety and Effectiveness 1 5

| Submitted by: | Elizabeth J. Mason, Sr. Regulatory Affairs Specialist |
|----------------------------------------|--------------------------------------------------------------------------------------------------|
| Address: | Nobel Biocare USA Inc.<br>22715 Savi Ranch Parkwav<br>Yorba Linda, CA 92887 |
| Telephone: | [phone], ext. 7830 |
| Facsimile: | [phone] |
| Date of Submission: | March 3, 2003 |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Trade or Proprietary<br>or Model Name: | Teeth in an Hour - ARK Implant Concept |
| Legally Marketed Device(s): | Branemark Novum (K000018)<br>Branemark System Implants - Immediate Function Indication (K022562) |

### Device Description:

The Teeth in and Hour – ARK Implant System is a concept bridging the use of existing modeling THE Teetir in and Tion - ARRS Inplant oy through a surgical template that transfers pre-determined implant locations to a patient.

Existing modeling techniques are performed to create a model of a patient's jaw in order to pre-determine implant location. A surgical template, comprised of acrylic material with cylinders and sleeves embedded, implant nodation: " F. Sargream for the purpose of transfering the pre-determined implant and based upon the modeling, to produced for the parposal template is held in position in the patient's mouth locations to the pation. "Daning ourgery, and steetomies are created using the surgical using anonor pine, which and accessories. Implants are then placed into the jaw using standard template, necessary unlo, and anchor pins are then removed. After the implants are inserted, this concept then allows for pre-produced prosthetic reconstruction to be attached.

### Indications for Use:

The Teeth in an Hour - ARK Implant Concept is indicated for the treatment of totally or partially rille Toch in an Prod. " K. R. major implant fixtures with immediate load function to restore the patient's chewing function.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three curved lines, resembling a human form or a stylized caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 1 - 2004

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

Re: K030685

Trade/Device Name: Teeth in an Hour-ARK Implant Concept Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: November 11, 2003 Received: November 12, 2003

Dear Ms. Mason:

This letter corrects our substantially equivalent letter of November 11, 2003 regarding the Device Name.

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 (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 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 continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Ques

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): K030685

Device Name: Teeth in an Hour - ARK Implant Concept

Indications For Use:

مم ج

> The Teeth in an Hour - ARK Implant System is indicated for the treatment of totally edentulous jaws for placement of implant fixtures with immediate load function to restore the patient's chewing function. The following prerequisites must be fulfilled:

- * adequate amount of jaw bone
- * the quality of jaw bone must be judged as adequate

* capability to open the mouth at least 50mm (this is especially important for lower jaws with the opposite jaw)

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)

Suze Rua,

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

510(k) Number.

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