KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)

K962753 · Biomedical Implant Technology, Inc. · DZE · May 19, 1997 · Dental

Device Facts

• Record ID: K962753
• Device Name: KWAN HEXAGONAL ABUTMENT IMPLANT SYSTEM (HAIS)
• Applicant: Biomedical Implant Technology, Inc.
• Product Code: DZE · Dental
• Decision Date: May 19, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Kwan HAIS is intended for single tooth replacement, as an intermediate abutment on long span bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support over dentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxilla. The HAIS is intended to be used in single stage and two stage procedures.

Device Story

Kwan Hexagonal Abutment Implant System (HAIS) is a dental implant system used by dentists/oral surgeons for tooth replacement and prosthetic support. System functions as an interface between bone-anchored implants and dental prosthetics (crowns, bridges, overdentures). Used in clinical settings for single or two-stage surgical procedures. Provides mechanical stability for fixed or removable dental restorations. Benefits patients by restoring masticatory function and aesthetics in edentulous or partially edentulous arches.

Technological Characteristics

Dental implant abutment system featuring a hexagonal connection interface. Designed for integration with dental implants to support various prosthetic configurations. Materials and specific dimensions not detailed in provided text.

Indications for Use

Indicated for patients requiring dental restoration, including single tooth replacement, long span bridgework, free-end edentulous area restoration, and support for overdentures or full arch fixed prostheses in totally or partially edentulous mandibles or maxillae. Used in single or two-stage surgical 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 19 1997

Biomedical Implant Technology, Incorporated
C/O Mr. Ronald McCarley
10304 Islander Drive
Boca Raton, Florida 33498

Re: K962753
Trade Name: Kwan Hexagonal Abutment Implant System (HAIS)
Regulatory Class: III
Product Code: DZE
Dated: October 11, 1996
Received: October 17, 1996

Dear Mr. McCarley:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Page 2 - Mr. McCarley

This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-320) at [phone]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at their toll free number [phone] or at [phone].

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control, and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

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Jan-13-97 12:56P OPHTEC McCarley 561-483-3312 P.02

# REVISED INDICATIONS FOR USE STATEMENT
(revised 1/10/96)

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510(k) Number: K962753

Device Name: Kwan hexagonal Abutment Implant System (HAIS)

Indications for Use:

The Kwan HAIS is intended for single tooth replacement, as an intermediate abutment on long span bridgework, as distal abutments on free-end edentulous areas to be restored with fixed bridgework, to support over dentures in totally or partially edentulous arches, and as abutments supporting a full arch fixed prosthesis in the totally edentulous mandible or maxilla. The HAIS is intended to be used in single stage and two stage procedures.

Per 21 CFR 801.109

Note: Underlined portion represents amendment.


Prescription Use ☑
(Per 21 CFR 801.109)