(85 days)
SDIB 101
Not Found
No
The summary describes a surgical instrument kit for fixture placement, with no mention of software, image processing, or AI/ML terms.
No.
The device is used to assist in fixture placement, which is a surgical procedure, but the device itself does not provide a therapeutic effect such as treating or preventing a disease. It is an instrument used during a procedure.
No
The device's intended use is "to assist in fixture placement," which is a procedural function, not a diagnostic one. There is no mention of identifying, detecting, or measuring a disease or condition.
No
The device description explicitly states the kit is composed of physical components (titanium tray, steel instruments), indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to assist in fixture placement," which is a surgical or procedural task performed directly on a patient.
- Device Description: The device is described as a kit with instruments made of titanium and steel, designed for assisting in a procedure.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed for testing samples taken from the human body. This device is clearly intended for use during a surgical procedure.
N/A
Intended Use / Indications for Use
The kit is indicated for use to assist in fixture placement.
Product codes
Not Found
Device Description
The Steri-Oss kit is designed to assist in fixture placement. The tray is composed of titanium and the instruments are composed of the firstruments are composible for the line of steel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not applicable.
Key Metrics
Not Found
Predicate Device(s)
Nobelpharma's Instrument set for fixture installation, SDIB 101.
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, a Bausch & Lomb company. Below the company name, the text "Original 510(k) Fixture Mount Kit" is displayed. The text is in a simple, sans-serif font and appears to be part of a product description or label. The logo is black and white.
K96321
V -5 |
ਣ ਤੇ
Section 7
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: | August 1996 |
Device Names : 1
Common Name: Kit
Trade Name: Fixture Mount Kit
Classification Name: Surgical Kit - General
Predicate Device:
Substantial equivalence is claimed to Nobelpharma's Instrument set for fixture installation, SDIB 101.
Device Description:
How device functions: The Steri-Oss kit is designed to assist in fixture placement.
Page 1 of 2
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
1
Original 510(k) Fixture Mount Kit
Device Description (cont.) :
Scientific concepts: Does not apply.
Characteristics: The tray is composed of titanium and the instruments are composed of the firstruments are composible for the line of steel.
Intended Use:
The kit is indicated for use to assist in fixture placement.
Comparison to Predicate:
The following table provides a comparison of the technological characteristic of the Steri-Oss kit to the predicate.
| Item | Predicate | Steri-Oss |
|---|---|---|
| Material | Titanium | |
| Steel | ||
| Aluminum | Titanium | |
| Steel | ||
| Silicone | ||
| Sterility | Non-Sterile | Same |
Performance Data:
Not applicable.
Steri-Oss Inc. - August 1996