AMORPHOUS DIAMOND COATED SCREW

K992538 · Nobel Biocare Uas, Inc. · DZE · Nov 23, 1999 · Dental

Device Facts

• Record ID: K992538
• Device Name: AMORPHOUS DIAMOND COATED SCREW
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: DZE · Dental
• Decision Date: Nov 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3640
• Device Class: Class 2

Indications for Use

The Amorphous Diamond Coated Screw is used to retain prosthetic components to dental implants or to other prosthetic components. The amorphous diamond coating will add a greater pre-load to the screw, which in turn help prevent the screw and prosthetic components from loosening.

Device Story

Amorphous Diamond Coated Screw functions as a mechanical fastener for dental prosthetic components. Device consists of titanium alloy screw with amorphous diamond coating applied to working length beneath head. Coating increases preload capacity during torque application, reducing risk of screw loosening compared to uncoated variants. Used in dental clinical settings by practitioners to secure prosthetics to implants. No software, electronics, or automated processing involved.

Clinical Evidence

Biological and mechanical test data performed to support indications for use. No clinical human trial data provided.

Technological Characteristics

Material: Titanium alloy. Surface: Amorphous diamond coating. Geometry: Threaded screw, internally hexed for driver. Mechanical principle: Increased preload via coating to prevent loosening. Sterile.

Indications for Use

Indicated for patients requiring retention of prosthetic components to dental implants or other prosthetic components.

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 Tiodized Screw (K964739)

Submission Summary (Full Text)

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Original 510(k) Amorphous Diamond Coated Screw

K992538

Page 1 of 2

Section 6 510(k) Summary

### Manufacturer Information:

| Submitter's Name: | Nobel Biocare USA, Inc. |
|-------------------|------------------------------------------------------|
| Address: | 22895 Eastpark Drive<br>Yorba Linda, CA 92887<br>USA |
| Contact Name: | Kim Rendon<br>Regulatory Affairs Analyst |
| Phone: | 714-282-4800 |
| Date Prepared: | July 1999 |

#### Device Name:

| Common Name: | Prosthetic Attachment Screw. |
|----------------------|---------------------------------|
| Trade Name: | Amorphous Diamond Coated Screw. |
| Classification Name: | Endosseous Dental Implant. |

### Predicate Device:

Substantial equivalence is claimed to the Nobel Biocare USA, Inc. Steri-Oss Tiodized Screw, 510(k) K964739, approved February 27, 1997.

### Device Description:

Device Function: The Amorphous Diamond Coated Screw is designed to fasten prosthetic components to implants and/or other prosthetic components. The attachment is secured by applying torque to the screw.

Scientific Concepts: Screws used to fasten prosthetic components can some times loosen. The greater the preload that is applied, the less chance there is that the screw will eventually become loose. Titanium screws with an amorphous diamond coating applied to the working length of the screw

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underneath the head, can be preloaded to a much greater torque than uncoated screws and thus are less likely to loosen.

Characteristics: The Amorphous Diamond Coated Screw is constructed of titanium alloy with an amorphous diamond coating applied to the working length of the screw underneath the head.

# Intended Use:

The Amorphous Diamond Coated Screw is used to retain prosthetic components to dental implants or to other prosthetic components. The amorphous diamond coating will add a greater preload to the screw, which in turn help prevent the screw and prosthetic components from loosening.

| Characteristic | Steri-Oss Tiodized<br>Screw | Amorphous Diamond<br>Coated Screw |
|------------------------------|--------------------------------------------------|-----------------------------------|
| Material | Titanium Alloy | Same |
| Surfactant | Anodized Titanium Alloy | Amorphous Diamond<br>Coating |
| Geometry | Threaded Screw | Same |
| Screw Design<br>(for driver) | Internally Hexed | Same |
| Intended Use | Fasten Steri-Oss System<br>Prosthetic Components | Same |
| Packaging | Chevron pouch in plastic<br>case | Same |
| Sterility | Sterile | Same |

### Comparison to Predicate:

# Performance Data:

Biological and mechanical test data were performed to support the indications for use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2:3 1999

Ms. Kim Rendon Requlatory Affairs Analyst Nobel Biocare USA, Inc. 22895 Eastpark Drive Yorba Linda, CA 92887

Re : K992538 Amorphous Diamond Coated Screw Trade Name: Requlatory Class: III Product Code: DZE Dated: July 28, 1999 Received: July 30, 1999

Dear Ms. Rendon:

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, Druq, 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, qood manufacturing practice, labeling, and prohibitions aqainst 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. Existinq major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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

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Page 2 - Ms. Rendon

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.

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA debornous in formalence 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 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 compriation and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to ene regaration" (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,

Timothy A. Ulatowski

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

Enclosure

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Original 510(k) Amorphous Diamond Coated Screw

### Section 8 Indications for Use

Page 1 of 1

510(k) Number (if known): K992538

Device Name: Amorphous Diamond Coated Screw

Indications For Use:

The Amorphous Diamond Coated Screw is used to retain prosthetic components to dental implants or to other prosthetic components. The amorphous diamond coating will add a greater pre-load to the screw, which in turn help prevent the screw and prosthetic components from loosening.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number J

| Prescription Use:<br>(Per 21 CFR 801.109) | <div style="display:inline-block;">✓</div> |
|-------------------------------------------|--------------------------------------------|
|-------------------------------------------|--------------------------------------------|

OR

| Over-The-Counter Use | ________________ |
|----------------------|------------------|
|----------------------|------------------|

(Optional Format 1-2-96)

| | Sivar Kuna<br>(Division Sign-Off) |
|--------------------------------|------------------------------------------------------------------------|
| Nobel Biocare USA<br>July 1999 | Division of Dental, Infection Control,<br>and General Hospital Devices |

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