KIS MT4
Device Facts
| Record ID | K960111 |
|---|---|
| Device Name | KIS MT4 |
| Applicant | The Implant Center of the Palm Beaches |
| Product Code | DZE · Dental |
| Decision Date | Mar 27, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3640 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The wide body abutments and pre-angled abutments are similar to those of other implant systems in their intended use which is to facilitate the prosthetic phase and installation of the prosthesis for the patient.
Device Story
Endosseous implant system comprising implants, tools, and abutments; includes pre-machined angulated abutments (15 and 25 degrees) and wide-body prosthetic abutments (4, 5, and 6 mm platform diameters). Used by periodontists/dentists in clinical settings to support prosthetic attachments following implant integration. Abutments placed on implant fixtures to enable prosthesis installation. Benefits include correction of angulation and support for wide-body prosthetic requirements.
Clinical Evidence
No clinical data provided; substantial equivalence based on design, material, and manufacturing similarity to predicate devices.
Technological Characteristics
Materials: ASTM B-348-93 titanium grade 3, 4, and titanium alloy ELI-grade 5. Components: Pre-machined angulated abutments (<30 degrees) and wide-body (4, 5, 6 mm) abutments. Sterilization: Gamma. Manufacturing: GMP compliant.
Indications for Use
Indicated for patients requiring prosthetic restoration via endosseous dental implants; facilitates prosthetic phase and installation of dental prosthesis.
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
- Dental Imaging Associates (K902433)
- Dental Imaging Associates (K902434)
- Dental Imaging Associates (K902435)
- Implant Innovations - Pre-angled abutments (K932123)
- Nobelpharma (K925766)
- Nobelpharma (K934826)
- Nobelpharma (K934495)
- Implant Innovations (K933969)
- Implant Innovations (K934126)
- Implant Innovations (K933462)
Related Devices
- K961382 — MT1A · The Emerging Technologies Group · Sep 25, 1996
- K961387 — MT-X · The Emerging Technologies Group · Sep 25, 1996
- K961385 — MT-3A · The Emerging Technologies Group · Sep 25, 1996
- K961386 — MT-2A · The Emerging Technologies Group · Sep 25, 1996
- K960110 — KIS MT3 · The Implant Center of the Palm Beaches · Mar 20, 1996
