THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM

K972417 · Bicon, Inc. · DZE · Sep 17, 1997 · Dental

Device Facts

• Record ID: K972417
• Device Name: THE 6.0 X 8.0MM DENTAL IMPLANT SYSTEM
• Applicant: Bicon, Inc.
• Product Code: DZE · Dental
• Decision Date: Sep 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 6.0 x 8.0mm implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement.

Device Story

The 6.0 x 8.0mm Dental Implant System is a surgical implant used by dental professionals to restore missing teeth. It is placed into edentulous sites in the mandible or maxilla to provide structural support for various dental prosthetics, including complete dentures, fixed bridges, partial dentures, or single tooth replacements. The device functions as an anchor for these restorations, facilitating functional and aesthetic rehabilitation for the patient.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental implant system with dimensions of 6.0mm x 8.0mm. Designed for surgical implantation in the mandible or maxilla. No specific materials or software algorithms described.

Indications for Use

Indicated for patients with edentulous sites in the mandible or maxilla requiring support for complete denture prostheses, fixed bridgework (terminal or intermediate abutment), partial dentures, or single tooth replacement.

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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SEP 1 7 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Vincent J. Morgan, D.M.D. President Bicon Dental Implants 1153 Centre Street Boston, Massachusetts 02130-3492

Re : K972417 The 6.0 x 8.0mm Dental Implant System Trade Name: Regulatory Class: III Product Code: DZE Dated: June 24, 1997 Received: June 27, 1997

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 Regulations, Title 21, Parts 800 to 895. ಗಿ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Patricia Caceres Flor

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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

6.0 x 8.0mm Dental Implant System

ענע עענישער יענע

Indications For Use:

The 6.0 x 8.0mm implant is designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement.

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

of CDRH, Office of Device Evaluation (ODE)

Russell Skipper

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

**Prescription Use** /
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

2003

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