OSSEOTITE DENTAL IMPLANT SYSTEM

K980549 · Implant Innovations, Inc. · DZE · Apr 28, 1998 · Dental

Device Facts

• Record ID: K980549
• Device Name: OSSEOTITE DENTAL IMPLANT SYSTEM
• Applicant: Implant Innovations, Inc.
• Product Code: DZE · Dental
• Decision Date: Apr 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An Endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient's chewing function. A successfully Osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium alloy implant when surgically implanted under controlled conditions, per well known clinical studies.

Device Story

Osseotite dental implant system; screw-type titanium alloy implant with defined surface morphology. Used in oral surgery for prosthetic attachment; restores chewing function. Implanted by specialized dental clinicians in clinical settings. Surface structure designed to enhance osseointegration, particularly in poor-quality bone (e.g., posterior maxilla). Clinical performance supported by animal studies showing increased bone-to-surface contact and countertorque resistance, and clinical trials demonstrating improved life table outcomes compared to machined-surface implants. Healthcare providers use clinical/radiographic screening to select candidates; device provides stable root form for restorative appliances. Benefits include improved anchorage and clinical outcomes in challenging bone conditions.

Clinical Evidence

Evidence includes published literature, animal studies, and ongoing clinical trials. Animal studies demonstrated increased bone-to-surface contact and higher countertorque extraction resistance for Osseotite vs. machined surfaces. Clinical trial data (n=2) reported an approximately 8.8% improvement in life table curves at 24 months for Osseotite implants placed in poor-quality bone compared to non-Osseotite machined implants.

Technological Characteristics

Screw-type endosseous dental implant; titanium alloy construction; defined surface morphology (Osseotite). Standalone device; non-powered. Surgical placement requires specialized clinical technique.

Indications for Use

Indicated for surgical placement in upper or lower jaw arches to restore chewing function via prosthetic attachment. Contraindicated in patients with insufficient bone width/height, poor oral hygiene, heavy smoking/tobacco abuse, blood disorders, infection, vascular impairment, uncontrolled diabetes, drug/alcohol abuse, chronic high-dose steroid therapy, anticoagulant therapy, or metabolic bone disease.

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

• 3i standard and self-tapping implants (K935544)

Submission Summary (Full Text)

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K980549

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APR 2 8 1998

# 510(k) SUMMARY

# 510(k) SUBMISSION: "Osseotite" Dental Implant System: "Enhanced Performance in Poor Bone"

To the Requestor:

This information is taken directly from the original Pre-Market Notification [510(k)], submission, provided to the United States Food and Drug Administration. No information regarding safety or efficacy has been deleted from that submission, for this summary.

- CLASSIFICATION NAME: Endosseous Dental Implant 1.
- COMMON/USUAL NAMES: Dental implants, Screw type dental implants, 2.
- 3. PROPRIETARY NAME: "Osseotite" Dental Implants
- CLASSIFICATION: Endosseous implants, per 872.3640 are class III devices. 4. Date PMA or notice of Completion of a PDP is required but no effective date has yet been established for the requirements for pre-market approval .

#### PERFORMANCE STANDARDS: Unknown ડ.

#### 6. FORM:

Screw type implant with a "Defined Surface Structure". In , the Company submitted information to support distribution clearance for a manufacturing process change, that would produce a "Defined Surface Structure (morphology) to the Company's threaded implants. This design feature, now known as "Osseotite"was cleared for commercial distribution on

Since introduction, "Osseotite" has generated significant interest in the dental implant community. Numerous academic and clinical researchers are involved with a variety of studies to evaluate the unique "Osseotite" surface and bone interface and reaction. Prospective clinical trials are ongoing (to support Class III clinical trial requirements for Pre-market Approval).

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Several studies have recently been published that present significant findings indicating the "Osseotite" surface performs overall, at least as well as other "non-Osseotite" surfaced implants and in some cases, appears to offer improved or enhanced performance in areas of the oral cavity, known (or commonly known) to have poor or poorer quality bone, as defined by Albrektsson ' such as the posterior maxilla.

Published studies are supported by preliminary results reported from clinical trials, using "Osseotite". Published results of animal studies using "Osseotite" implants contained within this report, demonstrate either an increase in bone-tosurface contact or an increase in resistance to countertorque extraction for "Osseotite" compared to machined surfaced implants. In two ongoing clinical trials. It is reported that "Osseotite" implants surgically placed in areas known to have poor quality bone, have life table curves that are approximately 8.8% ( "Osseotite" ys "non-Osseotite", machined surface implants) 0/0 greater than for similar implants at 24 months. This demonstrates improvement in outcomes of implants of similar design but with different surface morphology.

- SUBSTANTIAL EQUIVALENCE: 3i "Osseotite" Implants have been 7. determined substantially equivalent in design and materials to 31's standard and self-tapping implants, the and implant systems. Information and materials contained within this submission do not alter the Agency's original determination of substantial equivalence of the "Osseotite" implant, but does provide adequate information to support a marketing claim of "Enhanced performance" as defined herein.
#### 9. LABEL/LABELING MATERIALS:

Product labels will not change from those specified in the original "Osseotite" Pre-Market notification (K ). Marketing materials, including claims for "Enhanced performance in poor bone", "... poor quality bone", or similar wording will be developed and will site, or identify means by which completed. published studies and/or ongoing clinical study results may be obtained that support these "enhanced performance"claims.

#### "OSSEOTITE" TECHNICAL REPORT: 10.

Branemark PI, Introduction to Osseointegration. In: Branemark PI, Zarb GA, Albrektsson T, editors. Tissue integrated prosthesis: Osseointegration in clinical dentistry: Chicago: Quintessence, 1985. p 202.

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# 11. INDICATIONS FOR USE:

An Endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient's chewing function. A successfully Osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium alloy implant when surgically implanted under controlled conditions, per well known clinical studies.

There has been no change in the indications for use from those specified in the ). This submission only provides original Pre-Market Notification (K clinical information and data to support a claim of enhanced performance in poor quality bone, using the 3i "Osseotite" Implant.

#### CONTRAINDICATIONS: 12.

3i implants should not be used in cases where the remaining jaw bone is too diminished to provide adequate width or height to surround the implant. Lack of osseointegration or subsequent implant failure may occur in cases where there is insufficient available bone or poor bone quality, poor oral hygiene, heavy smoking or tobacco abuse, or medical conditions such as blood disorders, infection(s), vascular impairment at surgical site, uncontrolled diabetes, heavy smoking or tobacco abuse, drug or alcohol abuse, chronic high dose steroid therapy, medical conditions such as blood clotting disorders, current or ongoing anticoagulant therapy, metabolic bone disease or other metabolic or systemic disorders which may adversely affect bone or wound healing or cases in which the available bone is too diminished to provide adequate width or height to adequately hold implants and restorative appliances.

#### 13. WARNINGS:

For safe and effective use of 3i implants, it is strongly suggested that specialized training be undertaken since the surgical techniques required to place dental implants are highly specialized and complex procedures. Improper patient selection and technique can cause implant and/or abutment failure with possible loss of supporting bone.

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#### PRECAUTIONS: 14.

Thorough screening of prospective implant candidates must be performed. Visual inspection as well as panoramic and periapical radiographs are essential to determine anatomical landmarks, occlusal conditions, parodontal status, and adequacy of bone. Lateral cephalometric radiographs, CT Scans, and tomogram may also be beneficial.

#### ADVERSE EFFECTS: 15.

Loss of implant anchorage (failure to osseointegrate) and loss of the prosthesis are possible occurrences after surgery. Lack of quantity or quality of remaining bone, infections, poor patient oral hygiene or cooperation, and generalized diseases (diabetes, etc.) are some potential causes for loss of anchorage.

#### SURGICAL COMPLICATIONS: : 16.

The implant procedure has risks, including localized swelling, dehiscence, tenderness of short duration, edema, hematoma, or bleeding. Numbness of the lower lip and chin region following lower jaw surgery, and of the tissue beside the nose following upper jaw surgery, is a possible side effect of the surgery. Though it would most probably be of a temporary nature, in very rare cases, the numbness has been permanent. Gingival/Mucosal (gum tissue) ulceration, tissue reaction, or infection may occur, but generally responds to local care.

re 1 re

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 1998

Mr. William G. Conety ·Regulatory Affairs Implant Innovations®, Incorporated 4555 Riverside Gardens Palm Beach Gardens, Florida 33410

Re : K980549 Osseotite Dental Implant System Trade Name: Regulatory Class: III Product Code: DZE Dated: January 28, 1998 Received: January 28, 1998

Dear Mr. Conety:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Conety

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fdp.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number: K980549

Page 1 of 1

Device Name: "Osseotite" Dental Implant System (Original K935544 - Process change) Performance Claim: "Enhanced Performance in Poor Bone"

## INDICATIONS FOR USE:

An Endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient's chewing function. This submission provides information and animal/clinical data to support a clinical performance claim of "Enhanced Performance in Poor Quality Bone".

## DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Llive sus for MSR
(Division Sign-Off)
Division of Denmai, Infection Control,
and General Hospital Devices
510(k) Numoer K980549

Prescription Use: ***_*** OR Over-The-Counter Use: **_** Per 21 CFR 801.109)