REPLACE CYLINDRICAL IMPLANTS

K980439 · Steri-Oss, Inc. · DZE · Mar 16, 1998 · Dental

Device Facts

• Record ID: K980439
• Device Name: REPLACE CYLINDRICAL IMPLANTS
• Applicant: Steri-Oss, Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.

Device Story

The Steri-Oss Replace Cylindrical Implant acts as an artificial root to support prosthetic devices, mimicking natural dentition to restore masticatory function. The device is a tapered, cylindrical titanium implant available in diameters of 3.25, 4.3, 5.0, or 6.0 mm and lengths of 10-16 mm. It may be non-coated or coated with Hydroxyapatite (HA) or Titanium Plasma Spray (TPS). The device is used by dental professionals in a clinical setting to replace missing teeth. The implant is surgically placed into the jawbone to serve as a foundation for a crown, which functions as the artificial tooth. By providing a stable root structure, the device enables the patient to regain normal chewing function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium endosseous dental implant; tapered cylindrical geometry; available in 3.25-6.0 mm diameters and 10-16 mm lengths; surface options include non-coated, HA-coated, or TPS-coated; color-coded; sterile.

Indications for Use

Indicated for edentulous or partially edentulous patients requiring restoration of masticatory function via support for prosthetic devices.

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

• Steri-Oss Replace Titanium Implants

Submission Summary (Full Text)

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

K980439

ਤੇ ਭੇ

MAR 1 6 1998

Image /page/0/Picture/2 description: The image shows the logo for "STERI-OSS A DENTAL CARE COMPANY". The logo features a stylized "S" symbol on the left, followed by the company name in bold, sans-serif font. The words "A DENTAL CARE COMPANY" are smaller and positioned below "STERI-OSS".

Original 510 (k) Original 510 (K)
Replace Cylindrical Implants

Section 6

510 (k) Summary

Manufacturer In:formation:

| Submitter's Name: | Steri-Oss Inc. | | | |
|-------------------|------------------------------------------------------------------|--|--|--|
| Address: | 22895 Eastpark Drive<br>Yorba Linda, CA 92887<br>U.S.A. | | | |
| Contact’s Name: | Paul Gasser<br>Manager, Regulatory Affairs/<br>Quality Assurance | | | |
| Phone: | 714-282-4800 | | | |
| Date Prepared: | January 1998 | | | |

### Device Names:

Endosseous Dental Implant Common Name:

Replace Cylindrical Implant Trade Name:

Classification Name: Endosseous implant

## Predicate Device:

Substantial equivalence is claimed to Steri-Oss a Replace Titanium Implants.

# Device Description:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

How device functions: The Steri-Oss Replace Cylindrical How device functions: "The Secre as support for prosthetic devices
Implant is designed to serve as support for prosthetic devices Implant is debighed shewing function.

## Page 1 of 2

Steri-Oss Inc. - January 1998

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Original 510(k) Original Siondrical Implants

# Device Description (cont.) :

Scientific concepts: Natural dentition is composed of a root (subgingival) and a crown (supragingival) (Subgingival) and a store mimic this structure to aid the patient in restoring natural masticatory function. The patient is designed to serve as the root of the artificial Implant is designed to besigned to serve as the crown.

Characteristics: The implants are 3.25, 4.3, 5.0 or 6.0 mm in character from 10 - 16 mm in length and are composed of They are tapered, cylindrical and have a hexed titanium. citallum. They are copyplants may be non-coated or coated The Replace Cylindrical Implants utilize color (HA or TPS). coding.

#### Intended Use :

The implant is indicated for use in restoring masticatory fic imprane in the edentulous and/or partially edentulous patient.

### Comparison to Predicate:

The following table provides a comparison of the technological character stic of the Steri-Oss implant to the predicate.

| Item | Predicate | Steri-Oss |
|----------------------------|------------------------------------------------------|-------------|
| Material | Titanium without<br>coating or coated<br>(HA or TPS) | Same |
| Geometry | Threaded | Cylindrical |
| Surface<br>characteristics | Color coded | Same |
| Sterility | Sterile | Same |

## Performance Data:

Not applicable.

#### Page 2 of 2

Steri-Oss Inc. - January 1998

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 16 1998

Mr. Paul Gasser Manager, Regulatory Affairs/Quality Assurance Steri-Oss®, Incorporated 22895 EastpPark Drive Yorba Linda, California 92887

Re : K980439 Replace Cylindrical Implants Trade Name: Requlatory Class: III Product Code: DZE Dated: February 3, 1998 February 4, 1998 Received:

Dear Mr. Gasser:

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 reguirements 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 Regulations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Gasser

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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Cucoreste Hor

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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Original 510(k) Replace Cylindrical Implants

### Section 9

## Indications for Use

Page 1_of _1_

510(k) Number (:f known): K980439

Replace Cylindrical Implant Device Name:

Indications For Use:

The intended use for these devices is to serve as support for The Incended use for chose as patient chewing function.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Suan Runser |
|---------------------------------------------------------------------|-------------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | Ka80439 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|------------------------------------------|----|----------------------|
|------------------------------------------|----|----------------------|

(Optional Format 1-2-96)Steri-Oss Inc. - January 1998