ROUND DENTAL BUR

K964944 · Steri-Oss, Inc. · DZE · Feb 10, 1997 · Dental

Device Facts

• Record ID: K964944
• Device Name: ROUND DENTAL BUR
• Applicant: Steri-Oss, Inc.
• Product Code: DZE · Dental
• Decision Date: Feb 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use is to cut hard structures in the mouth, such as teeth or bone. One such application is to cut holes in cortical plate bone preparatory to creation of an osteotomy for placement of dental implants.

Device Story

Rotary cutting device; used by dentists/oral surgeons; manually operated via dental handpiece. Input: mechanical rotation and forward pressure against target tissue (teeth/bone). Output: physical removal of hard tissue. Facilitates osteotomy creation for dental implant placement.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Rotary dental bur; materials: carbide steel or tungsten carbide; shank types: friction grip or right angle latch; dimensions: 19-22mm length, 0.6-2.3mm head diameter; non-sterile.

Indications for Use

Indicated for patients requiring dental procedures involving the cutting of hard oral structures, including teeth and bone, specifically for osteotomy preparation during dental implant placement.

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

• Brasseler Corporation's Round Dental Burs

Submission Summary (Full Text)

{0}

K964944
FEB 10 1997

Original 510(k)
Round Dental Bur

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: December 1996

### Device Name:

Common Name: Dental Bur
Trade Name: Round Dental Bur
Standard Product Nomenclature (Classification Name): Bur, Dental

### Predicate Device:

Substantial equivalence is claimed to Brasseler Corporation's Round Dental Burs.

### Device Description:

#### How The Device Functions:

Dental burs are rotary cutting devices. Dental burs are shaped to provide a cutting action when simultaneously rotating and advanced forward into the target material with the application of pressure.

Page 1 of 2
Steri-Oss Inc. - December 1996
22

{1}

Original 510(k)
Round Dental Bur

Section 6
510(k) Summary

## Device Description (continued):

### Scientific Concepts:

A rotary cutting device.

### Characteristics:

Round Dental Burs are manufactured from carbide steel or tungsten carbide and may have friction grip or right anlge latch shanks..

## Intended Use:

The intended use is to cut hard structures in the mouth, such as teeth or bone.

One such application is to cut holes in cortical plate bone preparatory to creation of an osteotomy for placement of dental implants.

## Comparison to Predicate:

The following table provides a comparison of the technological characteristics of Steri-Oss' Round Dental Burs to the predicate burs.

### Product Comparison

| Specification/Characteristic | Predicate: Brasseler Corporation's Round Dental Burs | New Product: Steri-Oss' Round Dental Burs |
| --- | --- | --- |
| DESIGN | | |
| Size (overall length) | 19 - 22 mm | Same |
| Diameter (across head) | 0.6 - 2.3 mm | Same |
| Diameter (Shaft) | 1.6 - 2.35 mm | Same |
| MATERIAL | | |
| Body material | Carbide Steel | Same |
| PACKAGING | | |
| Container | Unknown | Plastic vial and cap with protective layers of foam |
| Sterility | NOT Provided Sterile | Same |

## Performance Data:

Not applicable.

Page 2 of 2
Steri-Oss Inc. - December 1996