(88 days)
Nobelpharma's 3.75 mm implant.
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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.
Yes
The device is described as an implant used to restore masticatory function, serving as support for prosthetic devices to restore patient chewing function, which is a therapeutic purpose.
No
Explanation: The device is described as an implant used to restore masticatory function, serving as support for prosthetic devices. Its purpose is therapeutic/restorative, not to diagnose a condition.
No
The device description clearly states it is a physical implant made of titanium, designed to be surgically placed in the jawbone. This is a hardware device, 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 support for prosthetic devices. This is a therapeutic and structural function within the body.
- Device Description: The device is an implant designed to mimic the root of a tooth and is composed of titanium. This is a physical implant placed within the body.
- 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 in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) as a structural component.
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
The Steri-Oss implant is designed to serve as support for prosthetic devices to restore patient chewing function. 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 3.8, 5.0 or 6.0 mm in diameter, from 8 - 18 mm in length and are composed of a titanium body and titanium coating. They are tapered, have a hexed superior surface, and are threaded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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
A mathematical justification demonstrates the substantial equivalence of the predicate to the Steri-Oss products.
Key Metrics
Not Found
Predicate Device(s)
Nobelpharma's 3.75 mm implant.
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, which is "A BAUSCH & LOMB Company". Below the logo, the text "Original 510 (k)" is present, possibly indicating a regulatory submission. The text "Replace TPS Coated Implants" is also present, which may refer to a product or procedure.
K962844 33
Section 6
OCT 1 8 1996
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 |
| Regulatory Affairs Specialist | |
| Phone: | 714-282-4800 |
Date Prepared:
Device Names:
Common Name : Implant
Trade Name: Replace TPS Coated Implants
Classification Name: Endosseous implant
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 Inc. - July 1996
1
Original 510(k) Replace 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 3.8, 5.0 or 6.0 mm in diameter, from 8 - 18 mm in length and are composed of a titanium body and titanium coating. They are tapered, have a hexed superior surface, and are threaded.
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 | Titanium |
| Diameter (mm) | 3.75 | 3.8, 5.0, 6.0 |
| Length (mm) | 7 - 20 | 8 - 18 |
| Geometry | Threaded | Same |
| 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 Inc. - July 1996