XP TECHNOLOGY ULTRASONIC SCALER

K042972 · American Eagle Instruments, Inc. · ELC · Mar 18, 2005 · Dental

Device Facts

• Record ID: K042972
• Device Name: XP TECHNOLOGY ULTRASONIC SCALER
• Applicant: American Eagle Instruments, Inc.
• Product Code: ELC · Dental
• Decision Date: Mar 18, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

An ultrasonic scaling system is used by dental professionals as 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. This device is contraindicated for children and adults with synthetic teeth. This device should not be used on patients or by users who have a pacemaker.

Device Story

Ultrasonic scaling system used by dental professionals in clinical settings for dental cleaning and periodontal therapy. Device utilizes ultrasonic vibrating scaler tip to remove calculus deposits from teeth. Operated by dental professionals; contraindicated for patients with synthetic teeth or patients/users with pacemakers. Device functions as a mechanical tool for dental hygiene; no complex software or algorithmic processing described.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic scaling system; operates via ultrasonic vibration of a scaler tip. Class II device (Product Code ELC).

Indications for Use

Indicated for dental professionals performing dental cleaning and periodontal therapy to remove calculus deposits. Contraindicated for patients with synthetic teeth and patients or users with pacemakers.

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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MAR 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Tom Thompson American Eagle Instruments, Incorporated 6575 Butler Creek Road Missoula, Montana 59808

Re: K042972

Trade/Device Name: XP TECHNOLOGY Ultrasonic Scaler Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 21, 2005 Received: February 25, 2005

Dear Mr. Thompson:

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 Amerate ents, 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 cither 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 Eederal Register.

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Page 2 - Mr. Thompson

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 vour 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,

Suyate Michael Durd.

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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## D. INDICATIONS FOR USE

510(k) Number : K042972

Device Name: XP TECHNOLOGY Ultrasonic Scaler

Indications For Use: ¡ An ultrasonic scaling system is used by dental professionals as 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 This device is contraindicated for children and adults with synthetic teeth teeth.

This device should not be used on patients or by users who have a pacemaker

Swor Runre

on Sien-Off) on of Anesthesiology, General Hospital, Josen Control, Dental Devices

... . . . . Number: __________________________________________________________________________________________________________________________________________________________

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)