(134 days)
Steri-Oss Titanium Implants, Healing Screws, Healing Abutments, Abutments
Not Found
No
The summary describes a physical dental implant made of titanium and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a dental implant system designed to restore chewing function, serving as support for prosthetic devices, not to treat or cure a disease or medical condition.
No
This device is described as an implant used to restore masticatory function, serving as a support for prosthetic devices. Its purpose is therapeutic (restoring function), not diagnostic (identifying a condition).
No
The device description clearly states the device is a titanium implant, which is a physical hardware component, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to restore masticatory function in patients by serving as a support for prosthetic devices. This is a direct therapeutic intervention within the body.
- Device Description: The device is a titanium implant designed to function as an artificial tooth root. This is a physical implant placed surgically.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is implanted within the body for a structural and functional purpose.
N/A
Intended Use / Indications for Use
The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.
Product codes
Not Found
Device Description
How device functions: The Steri-Oss Replace Titanium Implant System is designed to serve as support for prosthetic devices to restore patient chewing function.
Scientific concepts: Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown.
Characteristics: The implants are 4.3, 5.0 or 6.0 mm in diameter, from 10 - 16 mm in length and are composed of titanium. The Replace Titanium Implant System They are tapered, threaded and have a hexed superior surface. utilizes color coding.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Data: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Steri-Oss Titanium Implants, Healing Screws, Healing Abutments and Abutments.
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
Image /page/0/Picture/0 description: The image shows the logo for STERI-OSS, a Bausch & Lomb company. The logo consists of a stylized "S" shape on the left, followed by the text "STERI-OSS" in bold, uppercase letters. Below the text is the phrase "A BAUSCH & LOMB Company" in a smaller font size. The logo is black and white.
Original 510(k) Replace Titanium Implant System MAR - 5 199
3 ୧
Image /page/0/Picture/4 description: The image shows a handwritten string of characters. The characters appear to be a mix of letters and numbers. The string starts with the letter 'K', followed by the numbers '964220'. The characters are written in a cursive style, with some of the numbers connected to each other.
Section 6
510 (k) Summary
Manufacturer Information:
| Submitter's Name: | Steri-Oss Inc. |
|---|---|
| Address : | 22895 Eastpark Drive |
| Yorba Linda, CA 92887 | |
| U.S.A. | |
| Contact's Name: | Paul Gasser |
| Manager, Regulatory Affairs | |
| Phone : | 714-282-4800 |
| Date Prepared: | October 1996 |
Device Names:
Common Name : Implant
Trade Name: Replace Titanium Implant System
Classification Name: Endosseous implant
Predicate Device:
Substantial equivalence is claimed to Steri-Oss Titanium Implants, Healing Screws, Healing Abutments and Abutments.
Device Description:
How device functions: The Steri-Oss Replace Titanium Implant System is designed to serve as support for prosthetic devices to restore patient chewing function.
Page 1 of 2
Steri-Oss Inc. - October 1996
Steri-Oss Inc. 22895 Eastpark Drive Yorha Linda, CA 92687 Fax: (714) 998-9236 • (800) 993-8100
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Original 510 (k) Replace Titanium Implant System
Device Description (cont.) :
Scientific concepts: Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown.
The implants are 4.3, 5.0 or 6.0 mm in Characteristics: diameter, from 10 - 16 mm in length and are composed of They are tapered, threaded and have a hexed titanium. The Replace Titanium Implant System superior surface. utilizes color coding.
Intended Use :
The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.
Comparison to Predicate:
The following table provides a comparison of the technological characteristic of the Steri-Oss implant to the predicate.
| Item | Predicate | Steri-Oss |
|---|---|---|
| Material | Titanium | Same |
| Surface | ||
| characteristics | Non-color coded | Color coded |
| Sterility | Sterile | Same |
Performance Data:
Not applicable.
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Steri-Oss Inc. - October 1996