SURGIC IV IMPLANT CONTROL UNIT

K020327 · Nakanishi, Inc. · EBW · Apr 8, 2002 · Dental

Device Facts

• Record ID: K020327
• Device Name: SURGIC IV IMPLANT CONTROL UNIT
• Applicant: Nakanishi, Inc.
• Product Code: EBW · Dental
• Decision Date: Apr 8, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures.

Device Story

Surgic IV Dental Implant Unit is a control unit designed to power dental handpieces, contra angles, and attachments. It utilizes an electric micromotor to drive burs and drills for bone surgery. The system includes a roller pump for delivering saline or sterile water irrigation to the surgical site via a disposable, ETO-sterilized irrigation tube set. Operated by dental or oral surgeons in clinical settings, the device provides mechanical power and irrigation control to facilitate bone preparation. The healthcare provider uses the unit to perform precise bone procedures; the irrigation system helps maintain tissue temperature and clear debris. The device is not for use in environments with flammable anesthetics.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Control unit with electric micromotor and roller pump irrigation system. Micromotor and cord are autoclavable. Irrigation tube set is ETO sterilized, pyrogen-free. Operates as a dental handpiece accessory. Class I device.

Indications for Use

Indicated for dental, oral, and small surgical procedures requiring drilling, reaming, decorticating, and smoothing of bone and bone-related tissue. Contraindicated for use in the presence of flammable anesthetics.

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.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Hiroji Sekiguchi Marketing Director Nakanishi, Incorporated 700 Shimohinata Kanuma-Shi. Touchigi-Ken, JAPAN

Re: K020327

Trade/Device Name: Surgic IV Dental Implant Unit Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: January 29, 2002 Received: January 31, 2002

Dear Mr. Sekiguchi:

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.

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

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### Page 2 - Mr. Sekiguchi

of the Act or any Federal statutes and regulations administered by other Federal agencies. or the Act of all - such all the Act's requirements, including, but not limited to: registration r ou intist compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and ifsing (21 et read on the quality systems (QS) regulation (21 CFR Part 820); and if requirents as between 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 110(k) premarket notification. The FDA finding of substantial equivalence of your device to s rotts) premiered 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and alle Act may of overained its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Timothy Ulatowski

Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

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# 020327

### Indications For Use Statement

510(k) Number (if known):

Device Name:

Surgic IV Dental Implant Unit

Indications For Use:

The device is a control unit intended to drive contra angles and other attachments that are used with appropriate burs and drills for drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of dental, oral surgical and other small surgical procedures.

### Remarks:

The control unit is equipped with a roller pump to deliver saline solution or sterile water as irrigant to the handpiece. The electric micromotor and its cord are autoclavable. The irrigation tube set used between the irrigation nozzle at the handpiece and the saline solution bottle via roller pump is supplied as an accessory item in the control unit package. It is ETO sterilized for 10 sterility, pyrogen-free.

The control unit has risk of explosion if used in the presence of flammable anesthetics.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runne

| (Division Sign-Off) | |
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| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K020327 |

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use _

(Optional Format 1-2-96