← Product Code [ELC](/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC) · K053555 # ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L (K053555) _Guilin Woodpecker Medical Instrument Co., Ltd. · ELC · Aug 21, 2006 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K053555 ## Device Facts - **Applicant:** Guilin Woodpecker Medical Instrument Co., Ltd. - **Product Code:** [ELC](/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC.md) - **Decision Date:** Aug 21, 2006 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4850 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use Model :UDS-J/K/N1/N2 : 1. Removing supra and sub gingival calculus deposits and stains from the teeth 2. Periodontal pocket lavage with simultaneous ultrasonic tip movement Model: UDS-L : 1. Removing supra and sub gingival calculus deposits and stains from the teeth AND/OR 2. Periodontal pocket lavage with simultaneous ultrasonic tip movement 3. Preparing, cleaning, and irrigating root canals 4. Retrograde preparation of root canals ## Device Story Ultrasonic scaler system (Models UDS-J, UDS-K, UDS-L, UDS-N1, UDS-N2) used by dental professionals in clinical settings. Device utilizes ultrasonic vibration of a metal tip to mechanically remove calculus and stains from tooth surfaces and perform periodontal pocket lavage. Model UDS-L includes additional functionality for endodontic procedures, specifically root canal preparation, cleaning, and irrigation. Device operates via electrical power to drive ultrasonic transducer; output is mechanical vibration at the tip. Healthcare providers use the device to perform routine dental hygiene and endodontic therapy, facilitating removal of deposits and cleaning of root canal systems, thereby supporting periodontal and endodontic health. ## Clinical Evidence Bench testing only. ## Technological Characteristics Ultrasonic scaler; electrical energy source; metal scaling tips; handheld transducer assembly; standalone dental unit; no software/firmware described. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized depiction of an eagle or bird-like figure with three distinct heads or sections, suggesting a sense of unity or collaboration. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. ## AUG 2 1 2006 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Guilin Woodpecker Medical Instrument Company, Limited C/O Mr. Charlie Mack Principal Engineer International Regulatory Consultants 340 Shady Grove Road Flintville, Tennessee 37335 Re: K053555 ﮨﺴ ﺮ Trade/Device Name: Ultrasonic Scaler, Models UDS-J, UDS-K, UDS-N1, UDS-N2 Regulation Number: 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: August 9, 2006 Received: August 18, 2006 Dear Mr. Mack: 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 me road 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 Mr.), it may 80 ode of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ ## Page 2 -- Mr. Mark 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, 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 {2}------------------------------------------------ K053555 ## Indications for Use 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name: __ Ultrasonic Scaler, Models UDS-J, UDS-K, UDS-L, UDS-N1, UDS-N2 Indications For Use: Model :UDS-J/K/N1/N2 : 1. Removing supra and sub gingival calculus deposits and stains from the teeth 2. Periodontal pocket lavage with simultaneous ultrasonic tip movement Model: UDS-L : - 1. Removing supra and sub gingival calculus deposits and stains from the teeth AND/OR 2. Periodontal pocket lavage with simultaneous ultrasonic tip movement 3. Preparing, cleaning, and irrigating root canals 4. Retrograde preparation of root canals Prescription Use X X (Part 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (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) Sincerly n of Anesthesiology, General Hospital, on Control, Dental Device ) Number: 105 335K Page 1 of 1 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K053555](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K053555) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com