LAKONG ULTRASONIC SCALER

K103498 · Lakong Medical Device Company, Ltd. · ELC · Mar 31, 2011 · Dental

Device Facts

• Record ID: K103498
• Device Name: LAKONG ULTRASONIC SCALER
• Applicant: Lakong Medical Device Company, Ltd.
• Product Code: ELC · Dental
• Decision Date: Mar 31, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lakong 2200 Ultrasonic Scaler is intended for use during dental cleanings and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.

Device Story

Lakong 2200 Ultrasonic Scaler is a dental device used by dental professionals for calculus removal. Device utilizes ultrasonic vibration delivered via a scaler tip to the tooth surface to facilitate cleaning and periodontal therapy. Operated in a clinical dental setting. Benefits include efficient removal of dental calculus compared to manual scaling.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ultrasonic scaler; utilizes ultrasonic vibration for calculus removal; intended for dental clinical use; class II device (21 CFR 872.4850).

Indications for Use

Indicated for dental cleanings and periodontal therapy to remove calculus deposits from teeth in patients requiring professional dental hygiene or periodontal treatment.

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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Danny Wang President Lakong Medical Devices Company, Limited 18525 East Gale Avenue City of Industry, California 91748

MAR 3 1 2011

Re: K103498 Trade/Device Name: Lakong 2200 Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scalar Regulatory Class: II Product Code: ELC Dated: March 23, 2011 Received: March 25, 2011

Dear Mr. Wang:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Wang

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use:

The following document provides a separate page indentifying the Indications for Use for the LK2200 Ültrasonic Scaler.

| 510(k) Number: | K103498 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Lakong 2200 Ultrasonic Scaler |
| Indications for Use: | The Lakong 2200 Ultrasonic Scaler is intended for use during dental cleanings and periodontal therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth. |
| Prescription Use | and / or Over the Counter Use |
| | (please do not write below the line- continue on another page if necessary ) |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Burns

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

510(k) Number: K103498