PREVAIL DENTAL IMPLANTS

K051189 · Implant Innovations, Inc. · DZE · Jun 8, 2005 · Dental

Device Facts

• Record ID: K051189
• Device Name: PREVAIL DENTAL IMPLANTS
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Jun 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

3i 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

PREVAIL dental implants are endosseous implants designed for surgical placement in the upper or lower jaw. They feature an internal and external hex connection and a lateralized seating surface. The device serves as a foundation for prosthetic attachments, including single tooth restorations, bridges, and overdentures. Used by dental surgeons in clinical settings, the implants provide mechanical stability for prosthetic components. The device is manufactured from Titanium Alloy (ASTM F-136) or Commercially Pure Titanium (ASTM F-67). By providing a secure anchor in the jawbone, the implants facilitate functional and aesthetic tooth replacement, with specific protocols for immediate loading in the anterior mandible when splinted.

Clinical Evidence

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

Technological Characteristics

Endosseous dental implants; materials: Titanium Alloy (ASTM F-136) or Commercially Pure Titanium (ASTM F-67); features internal and external hex connection with lateralized seating surface; available in lengths 8.5mm to 15.0mm; sterilization via ion beam irradiation.

Indications for Use

Indicated for patients requiring dental implants for prosthetic attachment in single tooth restoration, partially or fully edentulous spans, freestanding bridges, and overdenture retention. Immediate loading indicated for patients with ≥ 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 Implants (K031632)
• 3i Implants (K935544)

Submission Summary (Full Text)

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# JUN 8 - 2005

Implant Innovations, Inc. Implant Innovations, Inc.
Traditional 510(k) Premarket Notification – OSSEOTITE IOL Implant: Device Modification

## DEVICE NAME

1.0

| Device Trade Name | PREVAIL™ Implants |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Classification Name | Dental Implants |
| ADDRESS AND REGISTRATION FOR MANUFACTURING AND<br>STERILIZATION SITES | |
| Sponsor | Implant Innovations, Inc.<br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>Tel.: [phone] |
| Official Correspondent | Jim Banic<br>Regulatory Affairs Specialist<br>Implant Innovations, Inc.<br>Tel.: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Manufacturing Site | Implant Innovations, Inc.<br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>Registration No. 1038806 |
| Sterilization Site | Ion Beam Applications (IBA)<br>formerly Sterigenics<br>1148 Porter Avenue<br>Haw River, NC 27258<br>Registration No. 1036836 |

#### CLASSIFICATION INFORMATION 2.0

| Device Class | Class II |
|----------------------|----------------------|
| Classification Panel | Dental Devices Panel |
| Regulation Number | 21 CFR §872.3640 |
| Product Code | DZE |

### LEGALLY MARKETED DEVICE INFORMATION 3.0

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The PREVAIL Implants are the subject of this 510(k) submission and are similar The I REVAL Implants are and cleared in the following premarket notifications:

- K031632 OSSEOTITE IOL Implants, cleared by letter dated September . 16, 2003.
- 10, 2009: . dated June 16, 2004.
- K935544 3i Implants, cleared by letter dated March 13, 1995. .

The proposed design modifications of the PREVAIL implants do not affect the intended use or alter the fundamental scientific technology of the device. Intended use of a Comparison Chart contained in Section F of this premarket notification.

#### INTENDED USE/INDICATION FOR USE 4.0

3i dental implants are intended for surgical placement in the upper or lower jaw to If delian infpants for prosthetic attachment in single tooth restoration and in provide a means for probablians 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.

The intended use of the PREVAIL implants is identical to those for the predicate devices cleared in K031632.

#### DEVICE DESCRIPTION 6.0

The PREVAIL implants are the same as the OSSEOTITE IOL implants [K031632] designed with an internal and external hex connection. The PREVAIL [XV21052] designed with and lateralized seating surface on both the miplants will nave the eralled implants. The PREVAIL implants will be manufactured from Titanium Alloy per ASTM F-136 or Commercially Pure Titanium per ASTM F-67.

The PREVAIL implants will be available in lengths of 8.5mm to 15.0mm with a The I REVAL implants will on. Reference is made to Section E for copies of engineering drawings. Catalog numbers are referenced in the following table.

Furthermore, the OSSEOTITE IOL implants [K031632] have been added to this submission, unmodified, in order to expand the indications.

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Image /page/2/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 three stripes forming its wings, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 8 - 2005

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

Re: K051189

Trade/Device Name: Prevail Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: May 6, 2005 Received: May 10, 2005

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 Amendinone, or to arrived act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 Mr), it hay of cashes to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.

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### Page-2 Dr. Morgan

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DT 3 lobalites or weat your device complies with other requirements mean that IDA has made a decommanen ations administered by other Federal agencies. of the Act of ally I ederal statutes and registered. Including, but not limited to: registration You must comply with an the : loveling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Pat 607), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quarty sjoccare) ejections (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) This letter will anow you to begal mading of substantial equivalence of your device to a premarket notification: - The FDF Imalis 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 advice 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 outant other general miormational and Consumer Assistance at its toll-free Division of Dieself or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Implant Innovations, Inc. Implant Innovations, Inc.
Traditional 510(k) Premarket Notification – OSSEOTITE IOL Implant: Device Modification

# Indications for Use

# 510(k) Number (if known):

Device Name:

### Indications for Use:

3i dental implants are intended for surgical placement in the upper or lower jaw to
r the surprises in the best and more in single tooth restoration and in partially 3i dental implants are intention in surgical procession and in partially or
provide a means for prosthetic attachment in single tooth resoration and to retain provide a means for prosthetic attachment in single took. Food.
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 In addition, when a minimum of 4 miplains; = 10 million and may = "
mandible and splinted in the anterior region, immediate loading is indicated.

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

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)

Sper Alvarez

Division of Anesthesiology, General Hospital. Infection Control, Dental Devices

510(k) Number:_

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