IMPLANT CENTER

K072030 · Satelec - Acteon Group · DZI · Nov 19, 2007 · Dental

Device Facts

• Record ID: K072030
• Device Name: IMPLANT CENTER
• Applicant: Satelec - Acteon Group
• Product Code: DZI · Dental
• Decision Date: Nov 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2

Intended Use

The intended use of the Satelec Implant Center is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.

Device Story

The Satelec Implant Center is a dental operative unit serving as a base for dental tools and accessories. It supplies necessary utilities to these tools for use by qualified dental practitioners in a clinical setting. The device includes a casing that can be decontaminated with dental disinfectant wipes and utilizes sterile tubing for irrigation, which is ethylene oxide (EO) sterilized and intended for single use. The device functions as a support system for dental procedures, providing the power or utility interface required for handpieces and associated dental instruments. It does not perform automated analysis or diagnostic processing.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental operative unit; provides utilities to dental handpieces and accessories. Includes EO-sterilized single-use irrigation tubing. Casing compatible with dental disinfectant wipes. No software or complex algorithm described.

Indications for Use

Indicated for use by qualified dental practitioners as a base unit to supply utilities to dental tools and accessories.

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

• Cocoon Hygienist (K040529)

Submission Summary (Full Text)

{0}------------------------------------------------

K072036

## 8. Cleaning, Disinfecting, and Sterilization:

Unit casing can be decontaminated with dental disinfectant wipes.

Sterile tubing for irrigation is ethylene oxide (EO) sterilized and is for single use only.

Refer to specific user manuals for cleaning, disinfecting, and sterilizing the handpieces and cords used with the dental operative unit.

# 9. SMDA Summary of Safety and Effectiveness - "510(k) Summary"

A. Submitter Information SATELEC Z.I. du Phare, BP 30216 17, Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE

> Telephonê: 011 33 556 34 0607 Fax: [phone]

Contact Person:

Steve Salesky SATELEC c/o Acteon, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Telephone: [phone] Ext. 40 Fax: [phone] E-mail: [e-mail]

Date Prepared:

July 23, 2007

B. Device Identification

Common Usual Name: Dental operative unit and accessories

Proprietary Name: Implant Center

C. Identification of Predicate Device

| Device<br>Comments of Children of Children and Children | Applicant | 510(k) No.<br>The property of the control of the control of the contributed | Date Cleared |
|---------------------------------------------------------|-----------|-----------------------------------------------------------------------------|----------------------|
| Cocoon Hygienist | Satelec | K040529 | I<br>August 19, 2004 |

The Satelec Implant Center is substantially equivalent to the predicate device by Satelec, the Cocoon Hygienist (K040529) previously cleared by the FDA and currently marketed.

NOV 1 9 2007

{1}------------------------------------------------

### D. Device Description

The Satelec Implant Center is a dental operative unit that supplies utilities to The Sutoloo implane for dental tools and accessories for use by qualified dental practitioners.

#### E. Substantial Equivalence

0

The Implant Center and the predicate device, Cocoon Hygienist (K040529) are both dental operative units that supply utilities to and serve as a base for dental both dental operative anile that supplif and practitioners. Differences that tools and accessories for access relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the Implant Center.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## NOV 1 9 2007

SATELEC C/O Mr. Steve Salesky Quality Manager ACTEON, Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054

Re: K072030

Trade/Device Name: Implant Center Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Instrument and Accessories Regulatory Class: II Product Code: DZI Dated: November 12, 2007 Received: November 14, 2007

Dear Mr. Salesky:

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.

{3}------------------------------------------------

Page 2 - Mr. Salesky

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,

Neil R.P. Ogden

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

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number:

Device Name:

K072030

Implant Center

Indications for Use:

The intended use of the Satelec Implant Center is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

5-1

Over-The-Counter Use (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)

Suan Quare

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072030