REPLACE TITANIUM IMPLANT SYSTEM
Device Facts
| Record ID | K964220 |
|---|---|
| Device Name | REPLACE TITANIUM IMPLANT SYSTEM |
| Applicant | Steri-Oss, Inc. |
| Product Code | DZE · Dental |
| Decision Date | Mar 5, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.
Device Story
Replace Titanium Implant System; endosseous dental implant; serves as artificial root for prosthetic crown; restores masticatory function. Used in dental clinic by clinicians. Tapered, threaded titanium design; hexed superior surface; color-coded for identification. Sizes: 4.3, 5.0, 6.0 mm diameter; 10-16 mm length. Implant supports prosthetic devices to replace missing teeth.
Clinical Evidence
No clinical data; performance data not applicable.
Technological Characteristics
Titanium construction; tapered, threaded geometry; hexed superior surface; color-coded; diameters 4.3, 5.0, 6.0 mm; lengths 10-16 mm; sterile.
Indications for Use
Indicated for edentulous or partially edentulous patients requiring restoration of masticatory function via endosseous dental implants.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Steri-Oss Titanium Implants, Healing Screws, Healing Abutments and Abutments
Related Devices
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