STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS
Device Facts
| Record ID | K960886 |
|---|---|
| Device Name | STERI-OSS 6 MM DIAMETER HA COATED IMPLANTS |
| Applicant | Steri-Oss, Inc. |
| Product Code | DZE · Dental |
| Decision Date | Aug 1, 1996 |
| 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
Endosseous implant serves as artificial root for prosthetic tooth; supports masticatory function. Device implanted into jawbone by clinician. Mimics natural dentition structure; implant acts as root, abutment/prosthetic acts as crown. Available in 6 mm diameter, 8-18 mm lengths; cylindrical or threaded geometries. Titanium core with hydroxylapatite (HA) coating.
Clinical Evidence
No clinical data; substantial equivalence supported by mathematical justification.
Technological Characteristics
Titanium and hydroxylapatite (HA) construction. 6 mm diameter; 8-18 mm length. Threaded or cylindrical geometry. Flat or hex lock superior surface. Sterile.
Indications for Use
Indicated for edentulous or partially edentulous patients requiring restoration of masticatory function.
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
- Nobelpharma's 3.75 mm implant
Related Devices
- K961020 — STERI-OSS 6MM DIAMETER TPS COATED IMPLANTS · Steri-Oss, Inc. · Jun 5, 1996
- K973423 — STERI-OSS 3.25 MM REPLACE(HYDROXYAPATITE-COATED)DENTAL IMPLANT · Steri-Oss, Inc. · Dec 5, 1997
- K973433 — STERI-OSS 3.25 MM REPLACE(TITANIUM PLASMA SPRAYED) DENTAL IMPLANT · Steri-Oss, Inc. · Dec 5, 1997
- K240232 — EK D3.3 and Ultra Wide Implants · Hiossen, Inc. · Sep 13, 2024
- K022424 — REPLACE HA COATED IMPLANT, MODELS 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132 & 60162 · Nobel Biocare Uas, Inc. · Sep 27, 2002
