NOBLEPHARMA WIDE ACCESSORIES
Device Facts
| Record ID | K962403 |
|---|---|
| Device Name | NOBLEPHARMA WIDE ACCESSORIES |
| Applicant | Nobelpharma USA, Inc. |
| Product Code | DZE · Dental |
| Decision Date | Sep 6, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Nobelpharma BRÄNEMARK SYSTEM® - Wide Platform Accessories are intended to be used as accessories in conjunction with the Wide Platform endosseous implant system and in the exact same manner as their counterpart predicate product.
Device Story
System consists of dental implant components including hand instruments, healing abutments, impression copings, and machine instruments; used with BRÄNEMARK SYSTEM® Wide Platform Fixtures. Components facilitate surgical and restorative procedures for dental implants. Operated by dental professionals in clinical settings. Output provides mechanical support, site healing, or impression taking for prosthetic fabrication. Assists clinicians in implant placement and restoration; benefits patients by enabling functional dental reconstruction.
Clinical Evidence
No clinical data; substantial equivalence based on identical technological characteristics to predicate devices.
Technological Characteristics
Components include abutments, healing abutments, hand instruments, impression copings, and machine instruments. Design and materials are identical to existing BRÄNEMARK SYSTEM® predicate components. Mechanical interface specific to Wide Platform Fixtures.
Indications for Use
Indicated for use as accessories with Wide Platform endosseous dental implant systems for patients requiring dental restoration.
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
- Drills (K925770)
- Screw Taps (K925768)
- Hand Instruments (K925774)
- Healing Abutments (K925779)
- Cover Screws (K925771)
- Machine Instruments (K925775)
- MirusCone accessories (K961728)
- CeraOne accessories (K961737)
Related Devices
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- K063364 — ALPHA BIO DENTAL IMPLANT SYSTEM · Alpha-Bio Tec , Ltd. · Mar 14, 2007
- K230126 — Dentis s-Clean Regular Abutment · Dentis Co., Ltd. · Aug 4, 2023
- K162004 — PREMIUM Implant Systems SHELTA Implant Systems · Sweden & Martina S.P.A. · Dec 5, 2016
- K140934 — HIOSSEN IMPLANT SYSTEM · Hiossen, Inc. · Nov 12, 2014
