STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB
Device Facts
| Record ID | K981516 |
|---|---|
| Device Name | STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW IMPLANT HA COATED , REFER TO TABLE 1 IN SUB |
| Applicant | Sterngold/Implamed |
| Product Code | DZE · Dental |
| Decision Date | May 11, 1998 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Sterngold ImplaMed Implant System can be used in dental implant applications for oral rehabilitation of endentuous and partially dentate patients in the maxillae and mandible. Implant retained restoration may consist of single crowns or bridges as well as complete or partial dentures.
Device Story
Sterngold ImplaMed Hex Screw Implants are dental implants designed for oral rehabilitation. Available in TPS (Titanium Plasma Sprayed) and HA (Hydroxyapatite) coated versions. Used by dental professionals in clinical settings to support prosthetic restorations including single crowns, bridges, and dentures. Implants are surgically placed into the maxilla or mandible to provide a stable foundation for dental prosthetics, benefiting patients by restoring oral function and aesthetics.
Clinical Evidence
No clinical data provided; substantial equivalence based on device description and intended use.
Technological Characteristics
Dental screw implants; available in Titanium Plasma Sprayed (TPS) and Hydroxyapatite (HA) coated configurations. Designed for surgical implantation in the maxilla or mandible.
Indications for Use
Indicated for oral rehabilitation of edentulous and partially dentate patients in the maxillae and mandible requiring dental implants for single crowns, bridges, or complete/partial dentures.
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.
