STATIS DENTAL HANDPIECES

K071891 · Scican , Ltd. · EFB · Sep 13, 2007 · Dental

Device Facts

• Record ID: K071891
• Device Name: STATIS DENTAL HANDPIECES
• Applicant: Scican , Ltd.
• Product Code: EFB · Dental
• Decision Date: Sep 13, 2007
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The STATIS dental handpieces and drives are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth. They are designed for use by a trained professional in the field of general dentistry.

Device Story

STATIS dental handpieces and drives are mechanical instruments used by trained dental professionals in clinical settings. Devices function by providing rotational power to dental burs or polishing attachments for the removal of carious material, reduction of hard tooth structure, cavity preparation, and finishing of restorations. Operated by dentists or dental staff, these handpieces facilitate precise tooth modification and restoration procedures. Clinical benefit includes efficient and controlled removal of tooth structure and restorative materials, enabling effective dental treatment. No software or electronic processing is involved.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical dental handpiece and drive system. Operates via rotational energy for dental procedures. Class I device, Product Code EFB.

Indications for Use

Indicated for removal of carious material, reduction of hard tooth structure, cavity preparation, finishing of restorations, and polishing of teeth in general dentistry patients. For use by trained dental professionals.

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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## SEP 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Brenda Murphy Director of Regulatory Affairs SciCan Limited 1440 Don Mills Road Toronto, Ontario CANADA M3B 3P9

Re: K071891

Trade/Device Name: STATIS DENTAL Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: June 29, 2007 Received: July 9, 2007

Dear Ms. Murphy:

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 in the 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 - Ms. Murphy

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 egencies. 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 of 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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## Indications for Use Statement

510(k) Number (if known):

Device Name: STATIS DENTAL Handpieces

Indications For Use:

,

The STATIS dental handpieces and drives are intended for the removal of carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and for polishing teeth.

They are designed for use by a trained professional in the field of general dentistry.

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)

| (Division Sign-Off) | Surer Kunde |
|-----------------------------------------------------------------------------------|-------------|
| Division of Anesthesiology, General Hospital<br>Infection Control, Dental Devices | |
| 510(k) Number: | K071891 |

SCICAN
STATIS 510(k)
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