SPI VECTODRILL CERAMIC DRILLS

K070290 · Thommen Medical AG · NDP · Apr 17, 2007 · Dental

Device Facts

• Record ID: K070290
• Device Name: SPI VECTODRILL CERAMIC DRILLS
• Applicant: Thommen Medical AG
• Product Code: NDP · Dental
• Decision Date: Apr 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3980
• Device Class: Class 1

Intended Use

SPI® VECTOdrill™ Ceramic Drills are for use in the preparation of the implant site for all SPI® System implants.

Device Story

Reusable zirconia dental implant drill bits; used with SPI Dental Implant System. Includes pilot drill and progressive twist drills. Pilot drill initiates hole, allows lateral cutting for axial correction; twist drills provide automatic axial guidance via integrated tip. Used in dental clinics by professionals. Drills feature depth markings for VECTOdrill depth gauge; proximal end fits dental handpiece latch. Made of alumina toughened zirconia (ATZ); provided non-sterile; resterilizable up to 20 times. Benefits include efficient osteotomy preparation and precise axial alignment.

Clinical Evidence

Bench testing only. Testing established retention of cutting ability under aggressive conditions and confirmed mechanical properties are appropriate for safe use.

Technological Characteristics

Material: Alumina toughened zirconia (ATZ). Form factor: Pilot drill (2.0mm diameter) and twist drills (2.8mm, 3.5mm, 4.3mm diameters). Features: Integrated depth markings, dental handpiece latch interface. Reusable (up to 20 cycles). Sterilization: Resterilizable.

Indications for Use

Indicated for preparation of the implant site for all SPI® System dental implants.

Regulatory Classification

Identification

Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.

Predicate Devices

• Thommen Medical AG, SPI VECTOdrill stainless steel drills

Submission Summary (Full Text)

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510(k) Summary

1872 SPI® VECTOdrill™ Ceramic Drills

K070290

510(k) Summarv

APR 1 7 2007

# Thommen Medical AG SPI® VECTOdrill™ Ceramic Drills

#### ADMINISTRATIVE INFORMATION

Manufacturer Name:

Thommen Medical AG Hauptstrasse 26d CH-4437 Waldenburg, Switzerland Telephone [phone] Fax [phone]

Official Contact:

Representative/Consultant:

Orlando Antunes

Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone [phone] Fax [phone] email: [e-mail]

## DEVICE NAME

Classification Name: Trade/Proprietary Name: Common Name:

Accessories, Implant, Dental, Endosseous SPI® VECTOdrill" Ceramic Drills dental implant drill bit

DEVICE CLASSIFICATION

FDA has classified "Accessories, Implant, Dental, Endosseous" as Class I devices (21 CFR 888.3980), with a product code of NDP.

## INDICATIONS FOR USE

SPI® VECTOdrill™ Ceramic Drills are for use in the preparation of the implant site for all SPI® System implants.

## DEVICE DESCRIPTION

SPI® VECTOdrill™ ceramic drills are reusable zirconia dental implant drill bits for use with the SPI Dental Implant System. SPI VECTOdrill ceramic drills include a pilot drill and three progressive twist drills. The pilot drill has a sler, highly efficient tip that initiates

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K070290 a9z
SPI® VECTOdri\l" Ceramic Drills

the pilot hole without the need for a round bur. The pilot drill also has the ability to cut laterally, in order to allow slight axial correction. The twist drills do not cut laterally, which helps to avoid enlarging the diameter of the osteotomy site. Each twist drill has an integrated guide at the tip, which is the same diameter as the preceding drill, in order to provide automatic axial quidance.

The pilot drill has a diameter of 2.0 mm and is available in 29.0 mm and 34.0 mm lengths. The twist drill is available in three diameters (2.8 mm, 3.5 mm and 4.3 mm) and two lengths for each diameter (29.0 mm and 34.0 mm).

Both the pilot drill and the twist drill have the proximal end configured to fit into a dental handpiece latch. All SPI VECTOdrills have a length 0.5 mm longer than the corresponding SPI Dental Implants. Each drill has depth markings that correspond to the VECTOdrill depth gauge in increments of 1.5 mm, from 8.0 mm to 17.0 mm. SPI VECTOdrill ceramic drills are intended to be resterilized and reused up to 20 times.

SPI VECTOdrill ceramic drills are made of alumina toughened zirconia (ATZ). SPI VECTOdrill ceramic drills are packed individually in a transparent plastic tube contained in a sealed plastic sleeve and are provided non-sterile.

Testing of SPI VECTOdrill ceramic drills established their ability to retain their cutting ability under aggressive cutting conditions. Testing also resulted in the conclusion that the mechanical properties of SPI VECTOdrill ceramic drills are appropriate for their safe use.

#### EQUIVALENCE TO MARKETED DEVICE

Thommen Medical AG submits the following information to demonstrate that, for the purposes of FDA's regulation of medical devices, the SPI VECTOdrill ceramic drills are substantially equivalent in indications and design principles to the following predicate device: Thommen Medical AG, SPI VECTOdrill stainless steel drills which are considered Class I, exempt.

The SPI VECTOdrill ceramic drills have the following similarities to the predicate device:

- · has the same intended use,
- · uses the same operating principle,
- · incorporates the same design

In summary, the SPI VECTOdrill ceramic drills described in this submission are, in our opinion, substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Thommen Medical AG C/O Mr. Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

APR 1 7 2007

Re: K070290

Trade/Device Name: SPI® VECTOdrill™ Ceramic Drills Regulation Number: 21 CFR 872.3980 Regulation Name: Endosseous Dental Implant Accessories Regulatory Class: I Product Code: NDP Dated: January 29, 2007 Received: January 30, 2007

Dear Mr. Larson:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Larson

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Swifte Y. Michael Omd.

Chiu Lin, Ph.D. Director Division of Anesthesiology. General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Premarket Notification

SPI® VECTOdrill™ Ceramic Drills

KO70296

Indications for Use

Applicant:

Thommen Medical AG

510(k) Number (if known):

Device Name: SPI® VECTOdrill™ Ceramic Drills

Indications for Use:

SPI® VECTOdrill™ Ceramic Drills are for use in the preparation of the implant site for all SPI® System implants.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

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*K) Number K070290

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