BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM

K972029 · Bicon, Inc. · DZE · Aug 18, 1997 · Dental

Device Facts

• Record ID: K972029
• Device Name: BICON DENTAL IMPLANTS II PART ABUTMENT SYSTEM
• Applicant: Bicon, Inc.
• Product Code: DZE · Dental
• Decision Date: Aug 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Bicon Two Part Abutment is designed for use in the mandible or maxilla for the support of a terminal or intermediate crown for fixed bridgework or for a single tooth crown.

Device Story

Bicon Two Part Abutment system functions as dental implant component; provides structural support for prosthetic crowns. Device implanted in mandible or maxilla by dental clinician; serves as interface between dental implant and fixed bridgework or single tooth crown. System facilitates restoration of missing teeth; enables functional and aesthetic rehabilitation. Clinical benefit derived from secure attachment of dental prosthetics to underlying implant infrastructure.

Clinical Evidence

Bench testing only.

Technological Characteristics

Two-part dental abutment system designed for integration with dental implants in the mandible or maxilla. Mechanical design facilitates fixed bridgework or single tooth crown support. Sterilization and material specifications are subject to general controls and Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.

Indications for Use

Indicated for patients requiring support for a terminal or intermediate crown for fixed bridgework or a single tooth crown in the mandible or maxilla.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vincent Morgan, D.M.D. President Bicon, Incorporated 1153 Centre Street 02130 Boston, Massachusetts

UG 1 8 1997

Re : K972029 Bicon Dental Implants Two Part Abutment Trade Name: System Requlatory Class: III Product Code: DZE Dated: May 20, 1997 June 2, 1997 Received:

Dear Dr. Morgan:

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 (for the indications for use stated in the enclosure) 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, 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

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Page 2 - Dr. Morgan

through 542 of the Act for devices under the Electronic chrough 542 or the 1100 in provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA gescribed in your 510\n premaince of your device to a legally marketed predicate device results in a classification for your marketed predicate actres your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in ritro diagnostic devices), please contact the Office of Vitio draghobere actrios, / 18. Additionally, for questions on compriation and advertising of your device, please contact the Dromocion and adversions of [phone]. Also, please note the Orice Of Compriand, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general prematice noctrout responsibilities under the Act may be Information on your responsible Manufacturers Assistance oblained from the Divibion [phone] or [phone] or at at its coll free namber (o:s)/www.fda.gov/cdrh/dsmamain.html".

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

Enclosure

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PM. JACOBTHAI

Page

K972029 510(k) Number (if known):

Two Part Abutment System Device Name:

Indications For Use:

The Bicon Two Part Abutment is designed for use in the mandible or maxilla for The Droof a terminal or intermediate crown for fixed bridgework or for a single tooth crown.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number R972029

Prescription Use in (Per 21 Ci-R 801.109)

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Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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