I-SURGE

K071965 · Satelec · EFB · Sep 10, 2007 · Dental

Device Facts

• Record ID: K071965
• Device Name: I-SURGE
• Applicant: Satelec
• Product Code: EFB · Dental
• Decision Date: Sep 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Satelec i-Surge is intended to be used by qualified dental practitioners as an electric micro-motor handpiece with a straight, right or contra-angle attachment for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance.

Device Story

The i-Surge is an electric micro-motor dental handpiece used by dental practitioners for surgical procedures. It accepts straight, right, or contra-angle attachments. The device consists of a control unit with a front panel keyboard and a footswitch for selecting and adjusting operational settings. It is used in clinical settings to perform procedures such as implantology, endodontia, and periodontology. The device provides the mechanical power required for these dental interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electric micro-motor handpiece; includes control unit with keyboard and footswitch; supports straight, right, and contra-angle attachments. Class I device, product code EFB.

Indications for Use

Indicated for use by qualified dental practitioners for oral dental surgical procedures, including implantology, endodontia, periodontology, and dental maintenance.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• Suni Max (K000049)

Submission Summary (Full Text)

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K071965

SEP 1 0 2007

## 13. 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

Telephone: [phone] 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 12, 2007

B. Device Identification

Common Usual Name: Dental Handpiece

Proprietary Name: i-Surge

- C. Identification of Predicate Device

| Device | Applicant | 510(k) No. | Date Cleared |
|----------|-----------|------------|---------------|
| Suni Max | Satelec | K000049 | April 4, 2000 |

The Satelec i-Surge is substantially equivalent to the predicate device by Satelec, Suni Max (K000049) previously cleared by the FDA and currently marketed.

## D. Device Description

The Satelec i-Surge is intended to be used by qualified dental practitioners as an electric micro-motor handpiece with straight, right or contra-angle attachment for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance.

Functions and settings are selected and adjusted by the footswitch and / or the front panel keyboard on the control unit.

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K071965 16
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## E. Substantial Equivalence

Both the Satelec i-Surge and the predicate device, Satelec Suni Max (K000049) are intended to be used by qualified dental practitioners as an electric micromotor handpiece with straight, right or contra-angle for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance. Differences that exist between the devices relating to technical specifications, performances, and intended use are minor and do not affect the safety and effectiveness of the i-Surge.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of government.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SFP 1 0 2007

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

Re: K071965

Trade/Device Name: i-Surge Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: July 12, 2007 Received: July 16, 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.

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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.

Chiu Lin, Ph.D.

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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071

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## Indications for Use

K071965

510(k) Number:

Device Name: i-Surge

Indications for Use:

The Satelec i-Surge is intended to be used by qualified dental practitioners as an electric micro-motor handpiece with a straight, right or contra-angle attachment for oral dental surgical procedures including implantology, endodontia, periodontology, and dental maintenance.

Prescription Use × (Part 21 CFR 801 Subpart D) 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)

Suver Punse
(Division Sign-Off)

Division of Anesthesiology, General Hospital. Infection Control, Dental Devi

510(k) Number: k071965