(88 days)
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No
The 510(k) summary describes a dental implant made of titanium and hydroxylapatite, designed to restore chewing function. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components. The performance study is a mathematical justification of equivalence, not a performance evaluation of an AI/ML model.
Yes
The intended use of the implant is to restore masticatory function, which is a therapeutic purpose to improve a patient's health and quality of life by addressing a medical condition (edentulism/partial edentulism). Additionally, the device description mentions it serves as support for prosthetic devices to restore patient chewing function, directly linking it to a therapeutic outcome.
No
The device, an implant, is described as restoring masticatory function by serving as support for prosthetic devices (mimicking a tooth root). Its purpose is functional restoration and replacement, not diagnostic assessment or detection of a medical condition.
No
The device description explicitly states the implant is composed of titanium and hydroxylapatite (HA) and describes physical dimensions (diameter and length), indicating it is a physical medical device, not software-only.
Based on the provided text, 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 direct treatment/restoration of a physiological function within the body.
- Device Description: The device is an implant designed to be surgically placed within the body (mimicking a tooth root).
- 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 samples from the body. This device is designed to be implanted within the body.
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
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 titanium and hydroxylapatite (HA). They are tapered, have a hexed superior surface, and are threaded.
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
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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.)
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Predicate Device(s)
Nobelpharma's 3.75 mm implant
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, in a smaller font, is the text "A BAUSCH & LOMB Company." The overall design is simple and professional.
Original 510 (k) Replace HA Coated Implants
K96 2845
3 3
OCT 18 1996
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 |
| Regulatory Affairs Specialist | |
| Phone: | 714-282-4800 |
July 1996 Date Prepared:
Device Names:
Common Name : Implant
Replace HA Coated Implants Trade Name:
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 Inc. - July 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) Replace HA 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.
The implants are 3.8, 5.0 or 6.0 mm in Characteristics: diameter, from 8 - 18 mm in length and are composed of titanium and hydroxylapatite (HA). 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 and HA |
| 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.
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Steri-Oss Inc. - July 1996