STERI-OSS TIODIZED SCREW

K964739 · Steri-Oss, Inc. · DZE · Mar 31, 1997 · Dental

Device Facts

• Record ID: K964739
• Device Name: STERI-OSS TIODIZED SCREW
• Applicant: Steri-Oss, Inc.
• Product Code: DZE · Dental
• Decision Date: Mar 31, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

The intended use for Steri-Oss' tiodized® screws is the screw retained attachment of prosthetic components to one another and to dental implants.

Device Story

Prosthetic attachment screw used to fasten dental prosthetic components to each other and to endosseous dental implants; functions via torque application to create preload; tiodized® titanium alloy surface treatment allows higher torque application compared to untreated screws, reducing risk of loosening; operated by dental professionals in clinical settings; device provides mechanical fixation; benefits patient by increasing stability of dental prosthetic restorations.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Titanium alloy screws with proprietary anodization (tiodized®) coating; diameters 0.086-0.106 inches; lengths 0.160-0.576 inches; slotted, internally hexed, or externally hexed head designs; provided sterile.

Indications for Use

Indicated for the screw-retained attachment of prosthetic components to one another and to dental implants in patients requiring dental prosthetic restoration.

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' 1mm and 10mm Coping Screws

Submission Summary (Full Text)

{0}

MAR 31 1997
1964739

Original 510(k)
Tiodized® Screw (Slotted, and Internally and Externally Hexed)

Section 6

letterhead

## 510(k) Summary

### Manufacturer Information:

Submitter's Name: Steri-Oss Inc.

Submitter's Address: 22895 Eastpark Drive
Yorba Linda, CA 92887
U.S.A.

Contact's Name: Jeff Hausheer, Ph.D.
Steri-Oss Inc.

Contact's Telephone: [phone], extension 3815

Date Prepared: November 1996

### Device Name:

Common Name: Prosthetic Attachment Screw

Trade Name: Steri-Oss' Tiodized® Screw

Classification Name: Endosseous dental implant

### Predicate Device:

Substantial equivalence is claimed to Steri-Oss' 1mm and 10mm Coping Screws.

### Device Description:

#### How The Device Functions:

Attachment of prosthetic components to one another and to implants can be achieved with screw fastening systems. The attachment is secured by the application of torque to the screw.

Steri-Oss Inc. - November 1996

{1}

Original 510(k)

Tiodized® Screw (Slotted, and Internally and Externally Hexed)

Section 6

**510(k) Summary**

## Device Description (continued):

### Scientific Concepts:

Screws used to fasten the prosthetic components can sometimes loosen. The greater the preload that is applied, the less chance there is that the screw will eventually become loose. Titanium screws that have been "tiodized®" can be preloaded to a much greater torque than untreated prosthetic component screws and thus are less likely to loosen.

### Characteristics:

Tiodized® screws are manufactured in diameters (across the head) ranging from 0.086 to 0.106 inches and lengths ranging from 0.160 to 0.576 inches and are composed of titanium alloy that has been subjected to a proprietary anodization process. The screws are slotted or are internally or externally hexed for acceptance of driving tools such as screw drivers, hex drivers and wrenches. Tiodized® screws are provided sterile, and are packaged either individually or in sets of up to 6 screws. Tiodized® screws may also be packaged with dental implants or dental implant prosthetic components.

## Intended Use:

The intended use for Steri-Oss' tiodized® screws is the screw retained attachment of prosthetic components to one another and to dental implants.

## Comparison to Predicate:

The following table provides a comparison of the technological characteristics of Steri-Oss' tiodized® screws to the predicate screws.

Steri-Oss Inc. - November 1996

{2}

Original 510(k)
Tiodized® Screw (Slotted, and Internally and Externally Hexed)

Section 6
510(k) Summary

**Device Description (continued):**

**Product Comparison**

| Specification/Characteristic | Predicate: 1mm & 10mm Coping Screws | Steri-Oss' Tiodized® Screw |
| --- | --- | --- |
| DESIGN | | |
| Geometry | Threaded Screw | Same |
| External design (for driver) | Slotted | Slotted, Internally Hexed and Externally Hexed |
| MATERIAL | | |
| Body material | Titanium alloy | Same |
| Coating | None | Same |
| PACKAGING | | |
| Container | Chevron pouch in plastic case | Same |
| Sterility | Provided Sterile | Same |

**Performance Data:**

Not applicable.

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Steri-Oss Inc. - November 1996