MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER

K051910 · D.B.I. America Corp. · ELC · Sep 2, 2005 · Dental

Device Facts

• Record ID: K051910
• Device Name: MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER
• Applicant: D.B.I. America Corp.
• Product Code: ELC · Dental
• Decision Date: Sep 2, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ultrasonic Scaler is intended to be used by a dental hygienist for use during dental cleaning to remove calculus deposits from the teeth.

Device Story

Ultrasonic scaler used by dental hygienists in clinical settings for dental prophylaxis; removes calculus deposits from teeth via ultrasonic vibration; device operates as a handheld dental instrument; output is mechanical vibration at the tip to facilitate cleaning; benefits include efficient removal of dental calculus; device is a standard dental tool.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultrasonic scaler; handheld dental instrument; operates via ultrasonic vibration for calculus removal; class II device; product code ELC.

Indications for Use

Indicated for use by dental hygienists for the removal of calculus deposits from teeth during dental cleaning procedures.

Regulatory Classification

Identification

An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a symbol of three stylized human profiles facing right. The profiles are stacked vertically, with the top profile slightly larger than the others. The seal is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 2 2005

Mr. Ubiraci R. Fernandes Vice President D.B.I. America Corporate 2909 Busch Lake Boulevard Tampa, Florida 33614

Re: K051910

Trade/Device Name: Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: June 24, 2005 Received: July 14, 2005

Dear Mr. Fernandes:

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. Fernandes

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,

Syfette by. Micheline Onns

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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## Indication for Use

510(K) number (if known)

K0519/0

Device Name:

Ultrasonic Scaler (21CFR872.4850)

Indication for use:

Ultrasonic Scalet (21) - Pro/2400)
The Ultrasonic Scalet is intended to be used by a dental hygienist for use during dental
e the Ultraster and saley denosits from the teeth. The Ultrasonic Scaler is intended to be arrivery
cleaning to remove calculus deposits from the teeth.

**Prescription Use**
(Per 21 CFR 801.109) _/

Susan Runne

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

510(k) Number. K051916