ULTRASONIC SCALER ELEGANCE MS-10 (25K)

K040396 · Rolence Enteprise, Inc. · ELC · Apr 22, 2004 · Dental

Device Facts

• Record ID: K040396
• Device Name: ULTRASONIC SCALER ELEGANCE MS-10 (25K)
• Applicant: Rolence Enteprise, Inc.
• Product Code: ELC · Dental
• Decision Date: Apr 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

THE ELEGANCE MS-10 (25K) ULTRASONIC SCALER IS DESIGNED FOR USE IN PROPHYLAXIS TREATMENTS PERIODONTIA , AND OTHER AREAS OF OPERATIVE DENTISTRY.

Device Story

Elegance MS-10 (25k) is an ultrasonic scaler used by dental professionals in clinical settings. Device converts electrical energy into mechanical ultrasonic vibrations to remove dental calculus, plaque, and debris from tooth surfaces. Operates via handpiece with interchangeable tips; controlled by clinician to perform scaling and root planing. Benefits include efficient removal of hard deposits during periodontal and prophylactic treatments, facilitating improved oral hygiene and disease management.

Clinical Evidence

Bench testing only.

Technological Characteristics

Ultrasonic scaler; 25kHz operating frequency; electrical energy conversion to mechanical vibration; handpiece-based system with interchangeable scaling tips; Class II device (21 CFR 872.4850).

Indications for Use

Indicated for use in dental prophylaxis, periodontia, and operative dentistry 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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Public Health Service

APR 2 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sterling Cheng Manager Rolence Enterprise Incorporated 18-3, Lane 231, Pu Chung Road Chungli 320, Taiwan R.O.C.

Re: K040396

Trade/Device Name: Elegance MS-10 (25k) Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 6, 2004 Received: February 17, 2004

Dear Mr. Cheng:

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 approvisions 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 (1 WI (), it may be outsyst to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can or roundsh further announcements concerning your device in the Federal Register.

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## Page 2 - Mr. Cheng

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 moan that I Dr mas made a aves and regulations administered by other Federal agencies. of the Act of ally I oderal bates as requirements, including, but not limited to: registration 1 ou must comply with an are reseling (21 CFR Part 801); good manufacturing practice and listing (21 CF reful 007), accling systems (QS) regulation (21 CFR Part 820); and if requirements us bet form in are quadis ion 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) This reter will and in J . The FDA finding of substantial equivalence of your device to a premarket nonneation - The PDF 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), 11 you desire specific af 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 may obtain 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/dsma/dsmamain.html

Sincerely yours,

Qiu Lin, Ph.D.

nu 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

. .

510(k) Number (if known):___K040396

Device Name: ELEGANCE MS-10 (25k) ULTRASONIC SCALER

Indications for Use:

## THE ELEGANCE MS-10 (25K) ULTRASONIC SCALER IS DESIGNED FOR USE IN PROPHYLAXIS TREATMENTS PERIODONTIA , AND OTHER AREAS OF OPERATIVE DENTISTRY.

AND/OR Prescription Use x _ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Arbutz Beitz MD for Dr. Susan Kummer

(Division Sign-(Division Sign-Off, General Hospital, Infection Control, Dental Devices

510(k) Number. K040396