(85 days)
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Not Found
No
The summary describes a physical dental implant and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is described as an implant used for restoring masticatory function by serving as support for prosthetic devices (artificial teeth), which falls under the category of a medical device intended to restore function, not primarily to treat or cure a disease or medical condition in a therapeutic sense, but to replace a missing body part and restore function.
No
The device, a dental implant, is described as restoring masticatory function by serving as a support for prosthetic devices (acting as the root of an artificial tooth). Its purpose is restorative, not diagnostic.
No
The device description clearly states the device is an implant made of titanium, which is a physical hardware component.
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 edentulous and/or partially edentulous patients by serving as support for prosthetic devices. This is a therapeutic or restorative function, not a diagnostic one.
- Device Description: The device is a titanium implant designed to mimic the root of a tooth. This is a physical implant for surgical placement, not a reagent, instrument, or system used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVDs are used to perform tests on samples taken from the body to gain information about the body's state. This device is implanted into the body to restore a physical function.
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
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Device Description
How device functions: The Steri-Oss implant 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 6 mm in diameter, from 8 -They are 18 mm in length and are composed of titanium. available with a flat or hex lock superior surface, and are either cylindrical or threaded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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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)
A mathematical justification demonstrates the substantial equivalence of the predicate to the Steri-Oss products.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 graphic to the left of the company name, "STERI-OSS," which is written in a bold, sans-serif font. Below the company name, it says "A BAUSCH & LOMB Company" in a smaller, serif font. The overall design is simple and professional.
Original 510(k) Steri-Oss 6 mm Diameter TPS Coated Implants
JUN - 5 1996
32
Section 6
510(k) Summary
Manufacturer Information:
| Submitter's Name: | Steri-Oss |
|---|---|
| Address: | 22895 Eastpark Drive |
| Yorba Linda, CA 92687 | |
| U.S.A. | |
| Contact's Name: | Paul Gasser |
| Regulatory Affairs Specialist | |
| Phone: | 714-282-4800 |
| Date Prepared: | March 1996 |
Device Names:
Common Name: Implant
Trade Name: None
Endosseous implant Classification Name:
Predicate Device:
Substantial equivalence is claimed to Nobelpharma's 3.75 mm implant.
Device Description:
How device functions: The Steri-Oss implant is designed to serve as support for prosthetic devices to restore patient chewing function.
Page 1 of 2
Steri-Oss - March 1996
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. 22895 East Park Drive Yorba Linda, CA 92687 . (714) 282-6515 Fax: (714) 998-9236 . (800) 993-8100 Steri-Oss Inc. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1
Original 510(k) Steri-Oss 6 mm Diameter TPS Coated Implants
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.
Characteristics: The implants are 6 mm in diameter, from 8 -They are 18 mm in length and are composed of titanium. available with a flat or hex lock superior surface, and are either cylindrical or threaded.
Intended Use:
(1
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 | Titanium |
| Diameter (mm) | 3.75 | 6 |
| Length (mm) | 7 - 20 | 8 - 18 |
| Geometry | Threaded | Threaded or Cylindrical |
| Sterility | Sterile | Same |
Performance Data:
A mathematical justification demonstrates the substantial equivalence of the predicate to the Steri-Oss products.
Page 2 of 2
Steri-Oss - March 1996