AS 123 PROSTHETIC INSTRUMENTATION SYSTEM

K963951 · BioHorizons Implant Systems, Inc. · DZE · Dec 31, 1996 · Dental

Device Facts

• Record ID: K963951
• Device Name: AS 123 PROSTHETIC INSTRUMENTATION SYSTEM
• Applicant: BioHorizons Implant Systems, Inc.
• Product Code: DZE · Dental
• Decision Date: Dec 31, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Intended Use

The AS 123 Prosthetic Instrumentation System is a hand-operated instrument which facilitates the installation and removal of cover screws, temporary healing abutments, abutment screws and posts in dental implant procedures.

Device Story

Hand-operated dental instrument; facilitates installation/removal of cover screws, healing abutments, abutment screws, and posts. Features thumbwheel for tactile feedback; interchangeable driver bits; t-handle attachment for torque control. Used in dental clinics by clinicians; provides access to posterior regions. Benefits include improved vision, tactile control, and torque management during prosthetic component placement.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: surgical grade stainless steel. Operation: manual/hand-operated. Components: thumbwheel, interchangeable driver bits, t-handle attachment. Form factor: handheld dental instrument.

Indications for Use

Indicated for use by dental professionals for the installation and removal of cover screws, temporary healing abutments, abutment screws, and posts during dental implant procedures.

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

• Steri-Oss Prosthetic Instrumentation
• Implant Innovations, Inc. Drivers and Placement Instruments

Submission Summary (Full Text)

{0}

BioHorizons Implant Systems, Inc.
510(k) Notification
September 27, 1996
K963951
Dec. 31, 1996

# 510(k) Summary of Safety and Effectiveness

## Proprietary Name
AS 123 Prosthetic Instrument System

## Common Name
Screw installation and removal instrument

## Classification Name
Prosthetic accessory

## Classification
Class III

## Official Contact
R. Steven Boggan, M.S., M.B.A.
President
BioHorizons Implant Systems, Inc.
2129 Montgomery Highway
Birmingham, AL 35209
[phone]
FAX [phone]

## Device Description
The AS 123 Prosthetic Instrumentation System is a hand-operated instrument which facilitates the installation and removal of cover screws, temporary healing abutments, abutment screws and posts in dental implant procedures. All components are manufactured from surgical grade stainless steel.

The primary advantages of the AS 123 over other prosthetic instruments are as follows:
- advantage of vision and easy access to difficult-to-reach posterior regions
- tactile feedback of screw placement and removal
- control of torque associated with the operation

{1}

BioHorizons Implant Systems, Inc.
510(k) Notification
September 27, 1996

The thumbwheel operation provides excellent tactile feedback in placement of prosthetic components. Driver bits are easily interchangeable with the AS 123 instrument. A t-handle attachment provides the necessary torque for installation of abutment screws.

## Substantial Equivalence Information

The AS 123 Prosthetic Instrumentation System is substantially equivalent in all features which could affect safety or effectiveness to the Steri-Oss® “Prosthetic Instrumentation” and Implant Innovations, Inc. “Drivers and Placement Instruments”