(125 days)
Not Found
Not Found
No
The description focuses on the material properties and mechanical function of a screw, with no mention of AI or ML algorithms for analysis, prediction, or control.
No.
The device's intended use is for screw-retained attachment of prosthetic components to one another and to dental implants, which is a structural/mechanical function, not a therapeutic one that treats or prevents a disease.
No
Explanation: The device description states that the tiodized screws are for "screw retained attachment of prosthetic components to one another and to dental implants." This describes a functional component for assembly, not a device used to provide information about a patient's health status or condition.
No
The device description clearly describes physical screws made of titanium alloy, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the mechanical attachment of prosthetic components to dental implants. This is a structural and mechanical function within the body.
- Device Description: The description details a physical screw made of titanium alloy, designed for fastening. It describes its physical characteristics, manufacturing process, and how it's used with tools.
- Lack of Diagnostic Function: There is no mention of the device being used to test a sample from the human body (like blood, urine, tissue, etc.) to provide information about a disease, condition, or state of health.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide diagnostic information. This device is used in vivo (within the body) for a mechanical purpose.
N/A
Intended Use / Indications for Use
The intended use for Steri-Oss' tiodized® screws is the screw retained attachment of prosthetic components to one another and to dental implants.
Product codes
Not Found
Device Description
Attachment of prosthetic components to one another and to implants can be achieved with screw fasteming systems. The attachment is secured by the application of torque to the screw.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Steri-Oss' 1mm and 10mm Coping Screws.
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
MAR 3 1 1997 15964739
Original 510(k) Tiodized® Screw (Slotted, ared 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: | 714-282-4800, 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 fasteming systems. The attachment is secured by the application of torque to the screw.
Page 1 of 3
Steri-Oss Inc. - November 1996
: 1
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-Qss' tiodized® screws to the predicate screws.
Page 2 of 3
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.
Page 3 of 3
Steri-Oss Inc. - November 1996
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