(62 days)
K/DEN: Not Found
Not Found
No
The description focuses on the mechanical function and material of a dental bur, with no mention of AI or ML.
No.
The device's intended use is to cut hard structures like teeth or bone, which is a surgical tool function, not a therapeutic one. It does not treat or cure a disease or condition.
No
The device, dental burs, is described as a cutting device used to cut hard structures in the mouth, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical, rotary cutting device made of carbide steel or tungsten carbide, which are hardware materials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut hard structures in the mouth, such as teeth or bone." This is a mechanical action performed directly on the patient's body.
- Device Description: The device is described as a "rotary cutting device" that works by "simultaneously rotating and advanced forward into the target material with the application of pressure." This is a physical tool for surgical procedures.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device described is a surgical instrument used for cutting tissue within the mouth, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
Device Description
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.
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..
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth, teeth, bone, cortical plate bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not applicable.
Key Metrics
Not Found
Predicate Device(s)
Brasseler Corporation's Round Dental Burs
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3640 Endosseous dental implant.
(a)
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.(b)
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.
0
Original 510(k) Round Dental Bur
FEB 10 1997
Section 6
ietterhead
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: | 714-282-4800, 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
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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.
Companson 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.
Steri-Oss Inc. - December 1996
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