O BUTMENT ET IMPLANT

K961665 · O Co., Inc. · DZE · Nov 15, 1996 · Dental

Device Facts

• Record ID: K961665
• Device Name: O BUTMENT ET IMPLANT
• Applicant: O Co., Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The titanium endosseous implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices.

Device Story

Cylinder-shaped, commercially pure titanium endosseous screw implant; surgically placed in upper or lower jaw bone by dental professionals; provides structural support for prosthetic dental devices; design features external threads; physical integrity verified via lateral and vertical stress analysis.

Clinical Evidence

Bench testing only. Physical integrity verified through lateral and vertical stress analysis performed by Rocky Mountain Testing.

Technological Characteristics

Commercially pure titanium; cylinder-shaped; external threads; endosseous screw design.

Indications for Use

Indicated for patients requiring dental implants to support prosthetic devices in the upper or lower jaw arches.

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

• O Butment ES Implant (K923889)
• Screw-Vent Implant (K900179)

Submission Summary (Full Text)

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"O" Company, Inc.
NOV 15 1996
Dental Implant & Attachment Systems
600 Paisano NE
Albuquerque, NM 87123
510(K) SUMMARY
K961665

April 22, 1996

Contact Person: David D. Dalise
President / owner, "O" Company, Inc.

Trade Name: "O" Butment ET Implant
Common Name: Endosseous Screw Implant
Classification Name: Dental Implant Endosseous / Code 76DZE

Substantial Equivalence to: "O" Butment ES Implant referenced as K923889 and Screw-Vent Implant referenced as K900179

Description of Device: A cylinder shaped commercially pure titanium dental implant with external threads.

Intedended Use: The titanium endosseous implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices.

Substantial Equivalence: Substantial Equivalence for the "O" Butment ET Implant is based on the following comparison of predicate devices such as "O" Company's "O" Butment ES Implant and Dentsply's Screw Vent Implant. The design, function, labeling, material composition and intended use is equivalent to the devices currently marketed.

Non-clinical tests: Based on lateral and vertical stress analysis performed by Rocky Mountain Testing, it has been determined that the physical integrity of the implant has not been compromised by the modifications.

This data supports our determination that the "O" Butment ET Implant is substantially equivalent to the "O" Company's "O" Butment ES Implant (K923889).

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