IMPLANT CENTER 2

K091252 · Satelec · DZI · Jul 22, 2009 · Dental

Device Facts

• Record ID: K091252
• Device Name: IMPLANT CENTER 2
• Applicant: Satelec
• Product Code: DZI · Dental
• Decision Date: Jul 22, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2

Intended Use

The intended use of the Satelec Implant Center 2 is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.

Device Story

Implant Center 2 is a dental operative unit serving as a base for dental tools and accessories. Operated by qualified dental practitioners in a clinical setting; device supplies necessary utilities to connected tools. Functions as a support platform for dental procedures; output is the provision of power/utilities to accessories. Benefits include centralized control and utility management for dental instrumentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dental operative unit; serves as a base for dental tools and accessories. Provides utility supply to connected instrumentation. No specific materials, software, or connectivity details provided.

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

• Implant Center (K072030)

Submission Summary (Full Text)

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

JUL 2 2 2009

A. Submitter Information SATELEC 17, Avenue Gustave Eiffel BP 30216 33708 Merignac Cedex FRANČE

> Telephone: [phone] Fax: [phone]

Contact Person: Rick Rosati

SATELEC c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel, NJ 08054 Tel: [phone] Ext. 39 Fax: [phone] Email: [e-mail]

Date Prepared:

04 / 30 / 2009 REVISED 7/16/09

B. Device Identification

"Bone Cutting Instrument and Accessories" Common Usual Name:

Proprietary Name:

Implant Center 2

C. Identification of the Predicate Device

| Device | Applicant | 510(k) No. | Date Cleared |
|----------------|-----------|------------|----------------|
| Implant Center | Satelec | K072030 | 11 / 19 / 2007 |

The Satelec Implant Center 2 is substantially equivalent to the predicate device by Satelec, the Implant Center (K072030) previously cleared by the FDA and currently marketed.

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## D. Device Description

The Satelec Implant Center 2 is a dental operative unit that supplies utilities to and serves as a base for dental tools and accessories for use by qualified dental practitioners.

## E. Substantial Equivalence

The Implant Center 2 and the predicate device, Implant Center (K072030) are both dental operative units that supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners. Differences that exist between the devices relating to technical specification, performances and intended use are minor and do not affect the safety and effectiveness of the Implant Center 2.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 22 2000

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

Re: K091252

Trade/Device Name: IMPLANT CENTER 2 Regulation Number: 21 CFR 872.4120 Regulation Name: Bone Cutting Material and Accessories Regulatory Class: II Product Code: DZI Dated: April 29, 2009 Received: April 29, 2009

Dear Mr. Rosati:

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 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. Rosati

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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,

Sion Cunner

Susan Runner, D.D.S., M.A. Acting 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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## Indications for Use

510(k) Number:

Device Name:

IMPLANT CENTER 2

Indications for Use:

"The intended use of the Satelec Implant Center 2 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)

- 12 - 15 - 12 - 12 - 14

AND/OR

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)

Ken Muly for MSR

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

510(k) Number: K091252