(68 days)
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No
The summary describes a dental implant, a physical device, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as an artificial root structure for abutments for bridgework and denture retention, designed to restore natural masticatory function. This fits the definition of a therapeutic device as it is intended to treat a condition (missing teeth) and restore function.
No
The device description states it functions as a replacement for the root portion of natural dentition and serves as a structural component for prosthetics, indicating a therapeutic or restorative purpose rather than a diagnostic one.
No
The device description clearly describes a physical implant made of titanium, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description and Intended Use: The description clearly states the device is an "implant" intended for use "in the mandible and maxilla" as an "artificial root structure." This means it is a device that is surgically placed inside the body.
- Lack of IVD Characteristics: There is no mention of testing samples, analyzing biological markers, or providing diagnostic information based on laboratory analysis.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
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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 titanium.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mandible and maxilla
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)
Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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 features a stylized "S" made of horizontal lines on the left. To the right of the "S" is the text "STERI-OSS" in a bold, sans-serif font. Below the company name is the text "A BAUSCH & LOMB Company" in a smaller, sans-serif font.
Original 510 (k) TPS Apical Implant NOV - 5 199
। ਰੇ
1963401
Section 6
510 (k) Summary
Manufacturer Information:
| Submitter's Name: | Steri-Oss |
|---|---|
| Address: | 22895 Eastpark Drive |
| Yorba Linda, CA 92887 | |
| U.S.A. | |
| Contact's Name: | Paul Gasser |
| Regulatory Affairs Specialist | |
| Phone: | 714-282-6515 |
| Date Prepared: | August 1996 |
Device Names:
- Common Name : Endosseous dental implant
TPS Apical Implant Trade Name:
Classification Name: Endosseous implant
Predicate Device:
Substantial equivalence is claimed to Steri-Oss' Apical Implants.
Device Description:
How device functions: The Steri-Oss implant functions by serving as a replacement for the root portion of natural dentition, upon which a prosthetic may be constructed.
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Steri-Oss Inc. - August 1996
Steri-Oss Inc. 22895 Eastpark Drive Yorba Linda, CA 92687 * (714) 282-6515 Fax: (714) 998-9236 • (800) 993-8100 ート | アイト | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | …………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………… - - -・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
1
Original 510(k) TPS Apical Implant
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 titanium.
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.
Comparison to Predicate:
The following table provides a comparison of the technological characteristics of the Steri-Oss implant to the predicate.
| Item | Predicate | TPS Apical Implant |
|---|---|---|
| Material | Titanium and HA | Titanium |
| Width (mm) | 3.8 | Same |
| Length (mm) | 8 - 18 | Same |
| Geometry | Threaded | Same |
| Sterility | Sterile | Same |
Performance Data:
Not applicable.