(7 days)
Not Found
No
The summary describes a physical dental implant and its intended use, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is described as an endosseous implant intended to support prosthetic devices and restore chewing function, which qualifies it as a therapeutic device.
No
The device is an implant for supporting prosthetic dental devices and restoring chewing function, not for diagnosing medical conditions.
No
The device description clearly states it is a physical, threaded root-form dental 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:
- Intended Use: The intended use clearly states that the device is an implant placed in the jaw to support prosthetic devices and restore chewing function. This is a surgical and restorative procedure performed directly on the patient's body.
- Device Description: The description details a physical implant made of titanium, designed to be surgically inserted.
- 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 medical implant.
N/A
Intended Use / Indications for Use
The Nobel Biocare Replace TiUnite Endosseous Implant is intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surgical procedure.
If the single stage procedure is used, these implants may be loaded immediately following insertion -- provided -- at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchorage, can most often be obtained.
Product codes
DZE
Device Description
The Replace TiUnite endosseous implant is a threaded root-form dental implant. It comes in widths of 3.5mm, 4.3mm, 5.0mm, and 6.0mm. Each width comes in lengths of 10mm, 13mm, and 16mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean
§ 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
SEP 2 6 2002
510(k) Summary of Safety and Effectiveness
| Submitted by: | Herbert Crane, Manager Regulatory Affairs |
|---|---|
| Address: | Nobel Biocare USA, Inc. |
| 22715 Savi Ranch Parkway | |
| Yorba Linda, CA 92887 | |
| Telephone: | (714) 282 4800 x5074 |
| Fax: | (714) 998 9348 |
| Date of Submission: | 18 Sept. 2002 |
| Classification Name: | Endosseous Dental Implant (21 CFR 872.3640) |
| Trade or Proprietary | |
| or Model Name: | Replace TiUnite Endosseous Implant |
| Legally Marketed Device: | Modified Surface Implant (K993595) |
Device Description:
The Replace TiUnite endosseous implant is a threaded root-form dental implant. It comes in widths of 3.5mm, 4.3mm, 5.0mm, and 6.0mm. Each width comes in lengths of 10mm, 13mm, and 16mm. The surface of the threaded portion of the implant has a titanium oxide layer that is uniformly thin (mean