← Product Code [ELC](/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC) · K140233 # ULTRASONIC SCALER (K140233) _Nanning Baolai Medical Instrument Co., Ltd. · ELC · Apr 6, 2015 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K140233 ## Device Facts - **Applicant:** Nanning Baolai Medical Instrument Co., Ltd. - **Product Code:** [ELC](/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC.md) - **Decision Date:** Apr 6, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.4850 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use The ultrasonic scaler is intended to: 1. Remove supra and sub gingival calculus deposits and stain from the teeth; 2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement; 3. Clean and irrigate root canals. ## Device Story Ultrasonic scaler P7 uses piezoelectric technology to generate high-frequency vibrations for dental procedures. Device consists of a control unit, handpiece with cord, and detachable scaling tips. Connects to external water supply for irrigation during operation. Operated by dental professionals in clinical settings. Piezoelectric transducer converts electric power into mechanical vibrations (28kHz ± 3kHz) at the tip to remove calculus, stains, and perform lavage or root canal irrigation. Water delivery through handpiece provides cooling and cleaning. Output allows clinicians to perform periodontal and endodontic maintenance, improving oral hygiene and patient dental health. ## Clinical Evidence No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), output characteristics (IEC 61205), biocompatibility (ISO 10993-5, ISO 10993-10), and steam sterilization validation (AAMI/ANSI ST79). ## Technological Characteristics Piezoelectric ultrasonic scaler. Handpiece shell: aluminum alloy. Frequency: 28kHz ± 3kHz. Components: control unit, handpiece, cord, detachable tips. External water supply connection. Sterilization: moist heat (steam) per AAMI/ANSI ST79. Standards: IEC 60601-1, IEC 60601-1-2, IEC 61205, ISO 10993-5, ISO 10993-10. ## 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. ## Predicate Devices - Guilin Woodpecker USD-L ultrasonic scaler ([K053555](/device/K053555.md)) ## 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 U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to symbolize the department's focus on health and well-being. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 6, 2015 Nanning Baolai Medical Instruments Co., Ltd. c/o Mr. Mike Gu Osmunda Medical Device Service Group Level 7, Jin Gui Business Center 982 Cunyun Road, Baiyun District Guangzhou, Guangdong 510420 CHINA Re: K140233 Trade/Device Name: Ultrasonic scaler P7 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic scaler Regulatory Class: II Product Code: ELC Dated: February 28, 2014 Received: March 3, 2015 Dear Mr. Gu: 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. {1}------------------------------------------------ Page 2 - Mr. Mike Gu 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K140233 Device Name Ultrasonic scaler P 7 #### Indications for Use (Describe) The ultrasonic scaler is intended to: - 1. Remove supra and sub gingival calculus deposits and stain from the teeth; - 2. Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement; - 3. Clean and irrigate root canals. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image is a logo for BAOLAI MEDICAL. The logo features the company name in blue, with a stylized "b" above it. The "b" is made up of several parallel lines that curve around to form the shape of the letter. The logo is set against a white background with a blue border. ## 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Submitter: | Nanning Baolai Medical Instruments Co., Ltd.,
7th Floor, General Building, Hetai Sci. &Tech. Park, No.9 Gaoxin
4th RD., Nanning ,Guangxi, 530007, China | |---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Contact Person: | Mike Gu
Regulatory Affairs Manager
Osmunda Medical Device Consulting Co., Ltd.
(+86)-020-62321333
(+86)-020-86330253 | | Secondary Contact Person: | Wanqing Bi
Deputy Manager
Nanning Baolai Medical Instrument Co., Ltd.
0086-771-3815998
0086-771-3217883 | | Device: | | | Trade Name: | Ultrasonic scaler P7 | | Common/Usual Name: | Ultrasonic scaler | | Classification Names: | Ultrasonic scaler | | Product Code: | ELC | | RegulationNumber | 21 CFR 872.4850 | | Date prepared | April 1th, 2015 | | Number of submission | K140233 | | Predicate Device(s): | Guilin Woodpecker USD-L ultrasonic scaler, K053555 | | Device Description: | Ultrasonic scaler employs piezoelectric technology to produce a
steady power. It is composed of a control unit housing a
generator that produces piezo-electric vibrations. The working
instrument for the ultrasonic scaler is the handpiece, which is
connected to the control unit via a handpiece cord. A scaling tip
specific to a particular procedure is attached to the end of the
handpiece. The ultrasonic scaler connects to an external water
supply and delivers water via connected handpiece. | | Intended Use: | The ultrasonic scaler is intended to:
1. Remove supra and sub gingival calculus deposits and
stain from the teeth;
2. Carry out periodontal pocket lavage with
simultaneous ultrasonic tip movement;
3. Clean and irrigate root canals. | | Technology: | The ultrasonic scaler is powered by the piezoelectric technology | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image is a logo for BAOLAI MEDICAL. The logo features a stylized letter "b" made of concentric circles. The text "BAOLAI MEDICAL" is written in a bold, sans-serif font below the letter "b". The background is a gradient of light blue to white. which is also employed by the predicate device. The electric power is transduced into high-frequency vibration via an ultrasonic transducer. The working instrument for both the proposed and predicate devices is the handpiece, which is connected to the control unit via a handpiece cord. Both the proposed and predicate ultrasonic scalers connect to an external water supply and deliver water via the handpiece. Determination of Substantial The ultrasonic scaler and its predicate device : Equivalence: - have the same intended use; - both employ piezoelectric technology and produce ultrasonic vibrations at a frequency of 28kHz ± 3kHz; - Have similar main components, i.e. control unit, handpiece cord, handpiece and detachable scaling tips. Compared to the predicate device, most of their specifications are identical except that the handpiece of the proposed ultrasonic scaler has a metal shell made from aluminum alloy rather than the plastic material used by the predicate device. The difference does not affect the safety of the proposed device as a biocompatibility testing aiming to the handpiece metal shell was conducted and result pass. Summary of of Non-Clinical Electrical safety tests according to IEC 60601-1: 2005+CORR. 1 Tests: (2006)+CORR. 2 (2007) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance; > Electromagnetic Compatibility Test according to IEC 60601-1-2:2007: General requirement for basic safety and essential performance standard: compatibility - Requirements and tests; > Bench testing according to IEC 61205:1993 Ultrasonics-Dental descaler systems-Measurement and declaration of the output characteristics. > Biocompatibility testing according to ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-10:2006 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains a logo for BAOLAI MEDICAL. The logo features a stylized letter "b" made of several concentric lines. Below the "b" is the text "BAOLAI MEDICAL" in a bold, sans-serif font. The text and the "b" are in a blue color, and the background is white. Moist sterilization validation according to AAMI / ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, (Consolidated Text) Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities Summary of Clinical Tests: The subject of this premarket submission, ultrasonic scaler, did not require clinical studies to support substantial equivalence. Conclusion: Based on the similarities in intended use, principles of operation, design rationale, test results, and performance, Nanning Baolai Medical Instrument Co., Ltd. considers the ultrasonic scaler to be substantially equivalent to the predicate device USD-L ultrasonic scaler. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K140233](https://fda.innolitics.com/submissions/DE/subpart-e%E2%80%94surgical-devices/ELC/K140233) **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