(185 days)
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Not Found
No
The description focuses on the physical structure and function of a dental implant, with no mention of AI or ML technologies.
Yes
The device is described as an "artificial root structure" that "functions by serving as a replacement for the root portion of natural dentition" to "aid the patient in restoring natural masticatory function," which indicates a therapeutic purpose of restoring a lost bodily function.
No
Explanation: The device description states it functions as a replacement for the root portion of natural dentition and serves as an artificial root structure for abutments. This indicates it is a prosthetic or restorative device, not one used for diagnosis.
No
The device description clearly describes a physical implant made of titanium with a hydroxylapatite coating, intended for surgical implantation in the mandible and maxilla. 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 serve as an artificial root structure in the mandible and maxilla for dental prosthetics. This is a surgical implant used in vivo (within the body).
- Device Description: The description details a physical implant designed to replace a tooth root. It functions mechanically to support a prosthetic.
- 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 clearly an in vivo medical device.
N/A
Intended Use / Indications for Use
The implant is indicated for use in the mandible and maxilla for use as an artificial root structure for abutments for bridgework and denture retention.
Product codes
Not Found
Device Description
The Steri-Oss implant functions by serving as a replacement for the root portion of natural dentition, upon which a prosthetic may be constructed.
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 implant is threaded with a 3.8 mm width and an 8, 10, 12, 14, 16 and 18 mm length. The superior aspect is flat. Half of the implant is coated with hydroxylapatite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
mandible and maxilla
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Static tensile, static 90° transverse, static 30° compression and 30° compression fatique were conducted on the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Steri-Oss' Titanium Screw Series Implants.
Reference Device(s)
Not Found
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/1 description: The image shows the Steri-Oss logo. The logo consists of a stylized letter S on the left, followed by the word "STERI-OSS" in bold, sans-serif font. Below the word "STERI-OSS" is the text "A BAUSCH & LOMB Company" in a smaller font size. The logo is black and white.
Original 510(k) Steri-Oss Apical Implant 20
Section 7
letterhead
AUG - 1 1996
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: | 714-282-6515 |
| Date Prepared: | January 1996 |
Device Names:
Endosseous dental implant Common Name:
Steri-Oss Apical Implant Trade Name:
Classification Name: Endosseous implant
Predicate Device:
Substantial equivalence is claimed to Steri-Oss' Titanium Screw Series Implants.
Device Description:
The Steri-Oss implant functions by How device functions: serving as a replacement for the root portion of natural dentition, upon which a prosthetic may be constructed.
Page 1 of 3
Steri-Oss, Inc. - January 1996
Steri-Oss Inc. 22895 Eastpark Drive Yorba Linda, CA 92687 * (714) 282-6515 Fax: (714) 998-9236 • (800) 993-8100
1
Original 510(k) Steri-Oss Apical Implant
ﻤﺴﺴﺴﺴ
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 implant is threaded with a 3.8 mm width and an 8, 10, 12, 14, 16 and 18 mm length. The superior aspect is flat. Half of the implant is coated with hydroxylapatite.
Intended Use:
The implant is indicated for use in the mandible and maxilla for use as an artificial root structure for abutments for bridgework and denture retention.
Page 2 of 3
2
Original 510(k) Steri-Oss Apical Implant
Comparison to Predicate:
The following table provides a comparison of the technological characteristics of the Steri-Oss implant to the predicate.
| Item | Predicate | Apical Implant |
|---|---|---|
| Material | Titanium alloy | Titanium alloy and HA |
| Coating | ||
| Configuration | All but 1 mm | |
| neck (8 mm | ||
| length) | 50% of apical threads | |
| All but 2 mm neck | ||
| (10, 12, 14, 16, | ||
| 18 mm lengths) | ||
| Width (mm) | 3.8 | Same |
| Length (mm) | 8, 10, 12, | |
| 14, 16, 18 | Same | |
| Design | Threaded root | |
| form with | ||
| flat superior | ||
| aspect | Same | |
| Packaging | Double vial | Same |
| Sterility | Sterile | Same |
Performance Data:
Static tensile, static 90° transverse, static 30° compression and 30° compression fatique were conducted on the predicate.
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Steri-Oss, Inc. - January 1996