AMORPHOUS DIAMOND COATED DRILL

K990846 · Nobel Biocare Uas, Inc. · DZI · Jun 10, 1999 · Dental

Device Facts

• Record ID: K990846
• Device Name: AMORPHOUS DIAMOND COATED DRILL
• Applicant: Nobel Biocare Uas, Inc.
• Product Code: DZI · Dental
• Decision Date: Jun 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The drill is used to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The amorphous diamond coated drill design is intended to minimize corrosion and to increase longevity of the tool.

Device Story

Amorphous Diamond Coated Drill is a surgical bone-cutting instrument used by dental professionals to prepare osteotomy sites for endosseous dental implants. The device consists of a surgical-grade stainless steel body with an amorphous diamond coating on the cutting portion. It features three cutting flutes and supports both internal and external irrigation. The device is used in a clinical setting, attached to a standard dental handpiece. The diamond coating is intended to reduce corrosion and extend the tool's operational lifespan compared to traditional titanium nitride-coated drills. The healthcare provider uses the drill to manually create the implant site; the output is the physical preparation of the bone, which facilitates the subsequent placement of the dental implant.

Clinical Evidence

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

Technological Characteristics

Surgical grade stainless steel construction; amorphous diamond coating; three cutting flutes; internal or external irrigation; latch-end design for dental handpiece compatibility; non-sterile.

Indications for Use

Indicated for patients requiring osteotomy preparation in the maxilla or mandible for endosseous dental implant placement.

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

• Steri-Oss System Surgical Drill

Submission Summary (Full Text)

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# JUN 10 1999

Original 510(k) Amorphous Diamond Coated Drill

Image /page/0/Picture/2 description: The image shows a sequence of handwritten alphanumeric characters. The characters appear to be 'K990896'. The writing style is cursive and somewhat stylized, with some characters connected to each other. The image is in black and white.

## 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: | March 1999 |

#### Device Name:

| Common Name: | Surgical Drill. |
|----------------------|------------------------------------------|
| Trade Name: | Amorphous Diamond Coated Drill. |
| Classification Name: | Bone cutting instrument and accessories. |

#### Predicate Device:

Substantial equivalence is claimed to Nobel Biocare USA, Inc. Steri-Oss System Surgical Drill.

### Device Description:

Device Function: The Amorphous Diamond Coated Drill is designed for use in the preparation of an osteotomy for an endosseous dental implant site.

Scientific Concepts: Bone cutting instrument.

Page 1 of 2

Nobel Biocare USA March 1999

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Characteristics: The Amorphous Diamond Coated Drill is constructed of surgical grade stainless steel. The bone cutting portion of the drill is coated with amorphous diamond coating.

#### Intended Use:

The drill is used to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement.

#### Comparison to Predicate:

| Characteristic | Nobel Biocare<br>Steri-Oss System<br>Titanium Nitride Coated<br>Drills | Amorphous Diamond<br>Coated Drill |
|----------------|------------------------------------------------------------------------|-----------------------------------|
| Material | Stainless Steel | Same |
| Coating | Titanium Nitride | Amorphous Diamond |
| Design | Latch end to use with<br>handpiece | Same |
| Cutting Flutes | Two | Three |
| Irrigation | Internal | Internal or external |
| Sterility | Non-sterile | Same |
| Packaging | Plastic vial with foam<br>inserts | Same |

### Performance Data:

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

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 1999

Ms. Kim Rendon Regulatory Affairs Analyst Nobel Biocare USA, Incorporated 22895 East Park Drive Yorba Linda, California 92887

Re : K990846 Amorphous Diamond Coated Drill Trade Name: Requlatory Class: II Product Code: DZI Dated: March 12, 1999 Received: March 15, 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, good manufacturing practice, labelinq, 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 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 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 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 - Ms. Rendon

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

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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Original 510(k) Amorphous Diamond Coated Drill

### Section 8 Indications for Use

Page 1 of 1

510(k) Number (if known):

Device Name: Amorphous Diamond Coated Drill

Indications For Use:

The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement. The amorphous diamond coated drill design is intended to minimize corrosion and to increase longevity of the tool.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Susan Kunn |
|----------------------------------------|----------------------------------------|
| | (Division Sign-Off) |
| | Division of Dental, Infection Control, |
| | and General Hospital Devices |
| 510(k) Number | K990846 |
| Prescription Use _(Per 21 CFR 801.109) | OR Over-The-Counter Use _ |

(Optional Format 1-2-96)

Nobel Biocare USA March 1999