LIFECORE CONICAL ABUTMENT
Device Facts
| Record ID | K965135 |
|---|---|
| Device Name | LIFECORE CONICAL ABUTMENT |
| Applicant | Lifecore Biomedical, Inc. |
| Product Code | DZE · Dental |
| Decision Date | Feb 25, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
Implant systems are for use in single tooth, partially edentulous, completely edentulous, mandibles and maxillae as a support or attachment for prosthetic restoration. The restoration can be detachable (screw retained) prosthetics in multiple, free standing or terminal restorations.
Device Story
Conical abutment serves as interface between endosseous implant and prosthetic crown or bridgework; provides base for screw-retained detachable prosthetics. Used in oral surgery/restorative dentistry by clinicians. Device functions as mechanical support for dental restorations in upper or lower jaw.
Clinical Evidence
Bench testing only; no clinical data provided.
Technological Characteristics
Titanium construction; mechanical attachment for endosseous implants; conical form factor; non-powered; sterile.
Indications for Use
Indicated for patients requiring prosthetic restoration in single tooth, partially edentulous, or completely edentulous mandibles and maxillae.
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
- Lifecore Conical Abutments Systems (K924589, K954512)
- Bränimark Miruscone Abutment System (K944964, K981728)
- 3i Microminilplant System (Catalog # MCA 31-MCA 34)
- Steri-Oss HL Abutment System (Catalog # 2654-2657)
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- K984198 — WIDE BODY ABUTMENTS · Vident · Feb 18, 1999
