MINIMATIC VARIOUS IMPLANT SYSTEMS

K952905 · Minimatic, Inc. · DZE · Apr 16, 1997 · Dental

Device Facts

• Record ID: K952905
• Device Name: MINIMATIC VARIOUS IMPLANT SYSTEMS
• Applicant: Minimatic, Inc.
• Product Code: DZE · Dental
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Device Story

Dental devices designed, manufactured, and marketed by Minimatic; intended for use in dental procedures; claimed substantially equivalent to currently marketed dental devices.

Clinical Evidence

No clinical data provided; manufacturer attests to safety and effectiveness based on intended use.

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.

Submission Summary (Full Text)

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K95805

"Tomorrow's Technology Today"

APR 16 1997

June 23, 1995

FDA
LOU H1AVINKA HFZ-410
DEVICE CONTROL
9200 CORPORATE BLVD
ROCKVILLE, MD 20856

510K Summary

RE: 510K REVIEW AND UPDATE.

Minimatic attests that:

1. Minimatic is the designer, manufacturer, and marketer of the enclosed devices.
2. The devices are Dental devices that currently are classified in Class III.
3. The devices are substantially equivalent to devices currently being marketed.
4. The devices in and of themselves are considered safe and effective provided that the devices are utilized as intended.

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