CERTAIN PREVAIL DENTAL IMPLANT

K061629 · Implant Innovations, Inc. · DZE · Feb 23, 2007 · Dental

Device Facts

• Record ID: K061629
• Device Name: CERTAIN PREVAIL DENTAL IMPLANT
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Feb 23, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

3 i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures. In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

Device Story

Certain PREVAIL Implants are endosseous dental implants designed for surgical placement in the jaw to support prosthetic restorations. The device features a parallel-walled, straight-collared design with an internal connection and a lateralized seating surface. Used by dental surgeons in clinical settings, the implants provide a foundation for single teeth, bridges, or overdentures. The device is surgically implanted into the bone; the lateralized seating surface facilitates prosthetic attachment. By providing a stable anchor, the implants restore oral function and aesthetics for patients with missing teeth. Immediate loading is supported under specific clinical conditions involving splinted mandibular implants.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Titanium Alloy (Ti6Al4V) per ASTM F-136. Design: Parallel-walled, straight-collared, internally connected with lateralized seating surface. Dimensions: Lengths 8.5-15mm; Diameters 4.0-5.0mm. Energy source: N/A (mechanical).

Indications for Use

Indicated for patients requiring prosthetic attachment in the upper or lower jaw for single tooth restoration, partially or fully edentulous spans, freestanding bridges, or overdenture retention. Immediate loading indicated for patients with at least 4 implants (≥ 10 mm length) placed and splinted in the anterior mandible.

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

• OSSEOTITE IOL Dental Implants (K031632, K051189)

Submission Summary (Full Text)

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| Submitter | Implant Innovations, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410 | FEB 23 2007 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact | Jim Banic<br>Regulatory Affairs Specialist<br>Implant Innovations, Inc.<br>4555 Riverside<br>Palm Beach Gardens, FL 33410<br>Tel. [phone]<br>Fax. [phone]<br>Email: [e-mail] | |
| Date Prepared | 07 June 2006 | |
| Device Name | Certain™ PREVAIL™ Implants | |
| Classification Name | Endosseous Dental Implant | |
| Device<br>Classification | Class II<br>Dental Devices Panel<br>21 CFR § 872.3640 | |
| Predicate<br>Devices | OSSEOTITE IOL Dental Implants<br>K031632, K051189 | |
| Performance | Performance standards have not been established by the<br>FDA under Section 514 of the Federal Food, Drug and<br>Cosmetic Act. | |
| Device Description | The Certain PREVAIL Implants are parallel walled,<br>straight collared internally connected implants with a<br>lateralized seating surface. They will be available in<br>lengths of 8.5, 10.0, 11.5, 13.0 and 15mm. The diameters<br>will be 4.0 and 5.0mm. The collar diameters will be 4.1mm<br>for the 4.0mm diameter implants and 5.0mm for the 5.0mm<br>implants. The seating surface will lateralize back to 3.4mm<br>for the 4.0mm diameter implants, and 4.1mm for the<br>5.0mm implants. The material these devices are made out<br>of is Titanium Alloy [Ti6A14V] per ASTM F-136. | |

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3i dental implants are intended for surgical placement in Indications for Use the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.

> In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

> > 008

The Certain™ PREVAIL™ Implants contain features Technological and functions which are similar to the currently available Characteristics OSSEOTITE® IOL Implants.

The Certain PREVAIL Implants are substantially Conclusion equivalent to the legally marketed OSSEOTITE® IOL Implants.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jim Banic Regulatory Affairs Specialist 3i Implant Innovations. Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410

FEB 2 3 2007

Re: K061629

Trade/Device Name: Certain™ PREVAIL™ Dental Implants Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 24, 2007 Received: January 25, 2007

Dear Mr. Banic:

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. Banic

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,

Clares

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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## 1061629 510(k) Number (if known):

Device Name: Certain™ PREVAIL™ Dental Implants

Indications for Use:

3 i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restoration and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

OR

Over the Counter Use:

Susan Dunne

is of of Anesthestology, Concelal Huspisal, · mon Control, Dental Devices

061629