O BUTMENT HS IMPLANT

K973926 · O Co., Inc. · DZE · Jan 5, 1998 · Dental

Device Facts

• Record ID: K973926
• Device Name: O BUTMENT HS IMPLANT
• Applicant: O Co., Inc.
• Product Code: DZE · Dental
• Decision Date: Jan 5, 1998
• 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

The "O" Butment HS Implant is a cylinder-shaped, commercially pure titanium dental implant featuring external threads and a hydroxylapatite coating. It is surgically placed into the bone of the upper or lower jaw by a dental professional to provide a stable foundation for prosthetic devices, thereby restoring a patient's chewing function. The device functions as an endosseous anchor for dental restorations.

Clinical Evidence

Bench testing only. Lateral and vertical stress analysis performed by Rocky Mountain Testing confirmed physical integrity.

Technological Characteristics

Commercially pure titanium dental implant; cylinder-shaped with external threads; hydroxylapatite coating. Mechanical device; no software or energy source.

Indications for Use

Indicated for patients requiring surgical placement of an endosseous implant in the upper or lower jaw arches to support prosthetic devices and restore chewing function.

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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K973926

JAN - 5 1998

## 510(K) SUMMARY

September 30, 1997

| Contact Person: | David D. Dalise<br>President / owner, "O" Company, Inc. |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name:<br>Common Name: | "O" Butment HS Implant<br>Endosseous Screw Implant<br>Classification Name: Dental Implant Endosseous / Code 76DZE |
| Substantial Equivalence to: | "O" Butment ES Implant referenced as K923889 and<br>Screw-Vent Implant referenced as K900179 |
| Description of Device: | A cylinder shaped commercially pure titanium dental<br>implant with external threads and a Hydroxylapatite Coating. |
| Intended Use: | The titanium endosseous implant is a device intended to be surgically<br>placed in the bone of the upper or lower jaw arches to provide support for<br>prosthetic devices. |
| Substantial Equivalence: | Substantial Equivalence for the "O" Butment HS Implant is<br>is based on the following comparison of predicate devices such as "O"<br>Company's "O" Butment ES Implant and Dentsply's Screw Vent<br>Implant. The design, function, labeling, material composition and intended use is<br>equivalent to the devices currently marketed. |
| Non-clinical tests: | Based on lateral and vertical stress analysis performed by Rocky Mountain<br>Testing, it has been determined that the physical integrity of the implant<br>has not been compromised by the modifications. |

This data supports our determination that the "O" Butment HS Implant is substantially equivalent to the "O" Company's "O" Butment ES Implant (K923889) and Dentsply's Screw Vent Implant (K900179).

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and clean, and it is easily recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 5 1998

Dr. David D. Dalise ·President / Owner "O" Company, Incorporated 600 Paisano, N.E., Suite A Albuquerque, New Mexico 87123

Re : K973926 "O" Butment HS Implant Trade Name: Requlatory Class: III Product Code: DZE September 30, 1997 Dated: Received: October 15, 1997

Dear Dr. Dalise:

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 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 Requlations, Title 21, Parts 800 to 895. A 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 (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation 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. Dalise

through 542 of the Act for devices under the Electronic enrough Size of Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as first receir wire 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally rinang or earsome device results in a classification for your marketed productorermits 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 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.fdal.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K973926
n/a

510(k) Number (if known):

Dental Implant Endosseous Device Name:

Indications For Use:

"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ewald Shipp

(Division Sian-Off and Ga 510k) Nu

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)