Who is the manufacturer of Ultrasonic Scaler Tips?

Guilin Refine Medical Instrument Co., Ltd. filed the 510(k) submission for Ultrasonic Scaler Tips (K230641).

What is the FDA product code for Ultrasonic Scaler Tips?

ELC. It is classified under 21 CFR 872.4850 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Ultrasonic Scaler Tips?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Ultrasonic Scaler Tips?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Ultrasonic Scaler Tips

K230641 · Guilin Refine Medical Instrument Co., Ltd. · ELC · Nov 21, 2023 · Dental

Device Facts

Record ID	K230641
Device Name	Ultrasonic Scaler Tips
Applicant	Guilin Refine Medical Instrument Co., Ltd.
Product Code	ELC · Dental
Decision Date	Nov 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.4850
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The ultrasonic scaler tips are intended for use by dental professionals to: 1. Remove supra and sub gingival calculus deposits and stain from the teeth; 2. Clean and irrigate root canals.

Device Story

Ultrasonic scaler tips function as accessories to piezoelectric ultrasonic handpieces and scaler units. Tips attach to handpieces via M3x0.6 internal thread; vibrate at ultrasonic frequencies (23kHz-33kHz) to remove calculus deposits, stain, and perform endodontic root canal cleaning/irrigation. Used by dental professionals in clinical settings. Output is mechanical vibration applied directly to tooth surfaces or root canals. Benefits include efficient removal of dental deposits and effective root canal preparation. Device is provided non-sterile and requires steam sterilization by the user.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench performance testing, including biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity), reprocessing validation (ISO 17665-1), and mechanical performance testing per ISO 18397 and ISO 3630-5.

Technological Characteristics

Materials: Stainless Steel 30Cr13 and Nickel Titanium Alloy. Energy: Piezoelectric ultrasonic vibration (23kHz-33kHz). Form factor: Tips with M3x0.6 internal thread. Sterilization: Steam sterilization (132°C for 4 minutes). Connectivity: Mechanical attachment to compatible piezo-electric dental scalers.

Indications for Use

Indicated for dental professionals to remove supra and sub gingival calculus and stain from teeth, and to clean and irrigate root canals.

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.

Predicate Devices

Sapphire Plus Tips (K960889)

Reference Devices

tün ultrasonic tips product family (K182145)
Symmetry S-Series Piezoelectric Scaling Tips (K053178)

Related Devices

K182145 — tün® ultrasonic tips product family · Engineered Endodontics · Jun 7, 2019
K132609 — EDS ULTRASONIC TIPS · Essential Dental Systems, Inc. · Jan 22, 2014
K163414 — Ultrasonic scaler · Nanning VV Dental Co., Ltd. · Nov 21, 2017
K061448 — BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES · Bonart Co., Ltd. · Aug 17, 2006
K994299 — ART-P3, MODEL P3-1-ART-A1 · Bonart Co., Ltd. · Mar 6, 2000

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. November 21, 2023 Guilin Refine Medical Instrument Co., Ltd. % Alice Yang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 CHINA Re: K230641 Trade/Device Name: Ultrasonic Scaler Tips Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: August 28, 2023 Received: August 28, 2023 Dear Alice Yang: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfpmn/pmn.cfm identifies combination product submissions. 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}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, # Michael E. Adjodha -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K230641 Device Name Ultrasonic Scaler Tips Indications for Use (Describe) - The ultrasonic scaler tips are intended for use by dental professionals to: - 1. Remove supra and sub gingival calculus deposits and stain from the teeth; - 2. Clean and irrigate root canals. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------|----------------------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {4}------------------------------------------------ # 510(K) Summary K230641 ### Prepared in accordance with the requirements of 21 CFR Part 807.92 Prepared Date: November 20, 2023 #### Submission sponsor 1. Name: Guilin Refine Medical Instrument Co., Ltd. Address: No.8-3, Information Industrial Park, High-Tech Zone, Qixing District, Guilin, GuangXi, China 541004 Contact person: Chen Judong Title: Management Representative E-mail: chenjudong@refine-med.com #### 2. Submission correspondent Name: Chonconn Medical Device Consulting Co., Ltd. Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067 Contact person: Alice Yang E-mail: yangjie@chonconn.com Tel: +86-755 33941160 | Trade/Device Name | Ultrasonic Scaler Tips | |-------------------|---------------------------------------------------| | Model | GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1 | | Regulatory Class | Class II | | Classification | 21 CFR 872.4850 / Ultrasonic scaler / ELC | | Submission type | Traditional 510(K) | #### 3. Subiect Device Information #### 4. Predicate Device - 1. Sapphire Plus@ Tips, San Diego Swiss Machining, K960889 (Primary) - 2. tün® ultrasonic tips product family, Engineered Endodontics., K182145 (Reference) Symmetry S-Series Piezoelectric Scaling Tips, Hu-Friedy Manufacturing Company, Incorporated, 3. K053178 (Reference). #### 5. Device Description Ultrasonic scaler tips are an accessory to a piezoelectric ultrasonic handpiece and scaler unit. The devices are used during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the teeth and/or root of the teeth for repair. The models are GD1, GD2, GD4, GD5, GD6, PD1, PD3, PD4, PD4D, ED1. The Ultrasonic scaler tips are Section 5_510(k) Summary {5}------------------------------------------------ made from Stainless Steel 30Cr13 and the endo files are made of Nickel Titanium Alloy. The tips will beavailable in M3x0.6 internal thread . GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication. #### Intended use & Indication for use 6. The ultrasonic scaler tips are intended for use by dental professionals to: - 1. Remove supra and sub gingival calculus deposits and stain from the teeth; - 2. Clean and irrigate root canals. | Features | Proposed device Ultrasonic Scaler Tip | Primary Predicate device K960889 Sapphire Plus@ Tips | Reference Predicate device K053178 Symmetry S- Series Piezoelectric Scaling Tips | Reference Predicate device K182145 tün® ultrasonic tips Product Family | comment | |-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Product code | ELC | ELC | ELC | ELC | Same | | Regulation number | 21 CFR 872.4850 | 21 CFR 872.4850 | 21 CFR 872.4850 | 21 CFR 872.4850 | Same | | Regulation Class | Class II | Class II | Class II | Class II | Same | | Regulation Description | Scaler, Ultrasonic | Scaler, Ultrasonic | Scaler, Ultrasonic | Scaler, Ultrasonic | Same | | Intended Use | The ultrasonic scaler tips are intended for use by dental professionals to: 1. Remove supra and sub gingival calculus deposits and stain from the teeth; | Reconstructive dental tissue during endo root procedures, crown prep, canal prep. Remove perio prep, root prep | To be used by Dental Professionals during dental cleaning and periodontal (gum) therapy to remove calculus, plaque and staining of the teeth by | tün® ultrasonic tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts | SE | | Features | Proposed device | Primary Predicate device K960889 Sapphire Plus@ Tips | Reference Predicate device K053178 Symmetry S- Series Piezoelectric Scaling Tips | Reference Predicate device K182145 tün® ultrasonic tips Product Family | comment | | | 2. Clean and irrigate root canals. | | application of an ultrasonic vibrating tip to the teeth. | and other intra- canal blockages. | | | Device Description | The device is used during dental cleaning and periodontal(gum) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the teeth and /or root of the teeth for repair. | The device is used during dental cleaning and periodontal(gum ) therapy to remove calculus deposits from teeth by application of ultrasonic vibration and in various endodontic applications to prepare the tooth and /or root of the tooth for repair. | This device is intended to be used by dental professionals for dental cleaning and periodontal therapy to remove calculus from the teeth | tün® ultrasonic tips are intended for use by dental professionals for the removal of soft and hard tissue during endodontic root canal preparation procedures. They can also aid in the removal of endodontic posts and other intra- canal blockages. | SE | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Operating Principle | The tips are used on piezo ultrasonic endodontic and scaler units which operate in the range of 23kHz- | Used in conjunction with piezoelectric ultrasonic handpiece and scaler. | Compatible with 27-32 kHz generator | tün tips interact with piezo ultrasonic hand piece and unit. tün tips are an accessory to a piezo ultrasonic | Different | | | | | | | | | | | | | | | | Features | Proposed device Ultrasonic Scaler Tip | Primary Predicate device K960889 Sapphire Plus@ Tips | Reference Predicate device K053178 Symmetry S- Series Piezoelectric Scaling Tips | Reference Predicate device K182145 tün® ultrasonic tips Product Family | comment | | | 33kHz. | Ultrasonic energy vibrates tip at high frequencies (up to 40,000 Hz) | | hand piece and unit. tün tips are used on piezo ultrasonic endodontic and scaler units which operate in the range of 20,000hz – 35,000hz. | | | Tip Shapes/Types | GD series and PD series(except for PD4D) are used to remove calculus deposits from teeth; PD4D and ED1 are used for root canal indication. | Four different types of tips will be manufactured as follows: Scaler tips, Plugger Tips, Cutting Tips, Spreader Tips | | 1 tip design is devised for post removal; the remaining 5 tips are designed for negotiating the various angles and directions of root canals. | Different | | Composition | Stainless Steel 30Cr13 Nickel Titanium Alloy(endo files) | 13-8 stainless steel | | 17-4ph Stainless Steel | Different | | Coatings | None | Titanium Nitride Zirconium Nitride | | Nickel Plating or Diamond Nickel Plating | Different | | Interaction with other products and/or items used with the product | brands of Piezo- Electric type dental ultrasonic Scalers that use an M3x0.6 thread | | | brands of Piezo- Electric type dental ultrasonic Scalers that use an M3x0.5 or M3x0.6 thread | Same | | Features | Proposed device Ultrasonic Scaler Tip | Primary Predicate device K960889 Sapphire Plus@ Tips | Reference Predicate device K053178 Symmetry S- Series Piezoelectric Scaling Tips | Reference Predicate device K182145 tün® ultrasonic tips Product Family | comment | | Sterilization | Provided non- | Provided non- | Provided non- | Provided non- | Same | | Status | sterile. | sterile. | sterile. | sterile. | | | Sterilization method | steam sterilization Sterilization requirements: 4 minutes at 132 °C a drying time of minimum 20 minutes | Yes, no detail information | Steam sterilize for at least 4 minutes at 270 °F / 132 °C or 30 minutes at 250 °F / 121 °C. Do not heat above 275 °F / 135 °C Recommend at least 30 minute dry time after sterilization cycle | Gravity Steam Sterilizer: • Temperature: 250°F /121°C. • Cycle Time: 30 minutes • Maximum Dry Time: 30 minutes Prevacuum Steam Sterilizer: • Temperature: 270°F/132°C. • Cycle Time: 4 minutes • Maximum Dry Time: 30 minutes | Different | | Mechanism of treatment | Application of an ultrasonic vibrating scaler tip to the teeth | Application of an ultrasonic vibrating scaler tip to the teeth | Application of an ultrasonic vibrating scaler tip to the teeth | Application of an ultrasonic vibrating scaler tip to the teeth | Same | #### Comparison to the Predicate Device 7. {6}------------------------------------------------ Section 5_510(k) Summary {7}------------------------------------------------ Section 5_510(k) Summary {8}------------------------------------------------ #### Performance Data 8. The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility testing The biocompatibility evaluation for the Ultrasonic Scaler Tips was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management Section 5_510(k) Summary {9}------------------------------------------------ process". The biocompatibility testing included the following tests: - Cytoxicity - Skin Sensitization - Irritation - Acute Systemic Toxicity - Material-mediated Pyrogens # Reprocessing Validation Sterilization has been validated in conformance to the FDA recognized consensus standard ISO 17665-1:2006 Sterilization of health care products - moist heat - Part 1: requirements for the development, validation and routine control of a sterilization process for medical devices. Cleaning validation testing is performed in accordance with recommended evaluations as listed in AAMI TIR30, AAMI TIR12, and Guidance for Industry and FDA Staff - Processing Medical Devices in Health Care Settings. # Bench Performance Testing Testing was conducted to demonstrate conformity to the applicable clauses of the following standards: - . ISO 18397 Dentistry Powered scaler - ISO 3630-5 Dentistry Endodontic instruments Part 5: Shaping and cleaning instruments # Clinical data The subject of this premarket submission, ultrasonic scaler tips, did not require clinical studies to support substantial equivalence. #### 9. Conclusion Based on the similarities in intended use, principles of operation, design rationale, test results, and performance, the subject ultrasonic scaler tips are considered to be substantially equivalent to the predicate devices.