(122 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for the Lakong 2200 Ultrasonic Scaler. It indicates that the device has been found substantially equivalent to a predicate device. However, this document does not contain the acceptance criteria, reported device performance, or details of a study proving the device meets acceptance criteria.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with specific performance acceptance criteria for devices like an ultrasonic scaler, which is in a lower risk class (Class II).
Therefore, I cannot provide the requested information from the given input. The document is too limited to answer the specific questions about acceptance criteria and detailed study information.
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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 (800) 638-2041 or (301) 796-7100 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
§ 872.4850 Ultrasonic scaler.
(a)
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.(b)
Classification. Class II.