Integrated Endo System (Meet Endo-II)

K242317 · Denjoy Dental Co., Ltd. · ELC · Feb 13, 2025 · Dental

Device Facts

• Record ID: K242317
• Device Name: Integrated Endo System (Meet Endo-II)
• Applicant: Denjoy Dental Co., Ltd.
• Product Code: ELC · Dental
• Decision Date: Feb 13, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Integrated Endo System is dental device which combine in a single main control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation. The Integrated Endo System is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

Device Story

Integrated Endo System (Meet Endo-II) is a standalone AC-powered dental control unit with a touch display. It integrates four modules: endo motor (MeetMotor) for root canal preparation; dental obturator (MeetFill) for filling/pressurizing using resistance-wire heating; electronic apex locator (MeetPex) for working length measurement via electrical impedance; and ultrasonic handpiece (MeetActivator) for root canal irrigation. Used in dental clinics by trained professionals. The system processes electrical impedance signals for apex location and controls motor/heating parameters. Output is displayed on the touch screen to assist clinicians in performing root canal procedures. Benefits include consolidated control of multiple endodontic tools, improving workflow efficiency during root canal therapy.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility (ISO 10993), electrical safety (IEC 60601-1, IEC 80601-2-60), EMC (IEC 60601-1-2), wireless coexistence (ANSI/USEMCSC C63.27), reprocessing validation, and mechanical coupling verification (ISO 3964/14457). Usability testing with 15 participants demonstrated safe and effective use.

Technological Characteristics

AC-powered control unit with Li-Ion battery (14.4V, 4800mAh). Materials include stainless steel, aluminum, and TPR plastic (Class VI). Sensing via electrical impedance for apex location; ultrasonic vibration (45±10kHz) for cleaning. Connectivity via Bluetooth (2400-2483.5 MHz). Sterilization per ISO 17664/17665. Software classified as Moderate Level of Concern.

Indications for Use

Indicated for patients requiring root-canal treatment. Intended for use by trained dental professionals in professional health care facilities.

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

• EndoPilot2 (K202906)

Reference Devices

• MeetFill (D274830)
• Obtura Heated Gutta Percha System (K042828)
• Ultrasonic Module (K050895)

Submission Summary (Full Text)

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February 13, 2025

Denjoy Dental Co., Ltd. Chengfa Huang Quality Manager F4, Building A4, Lugu Medical Device Park, No.229 Guyuan Road Changsha, Hunan 410205 CHINA

Re: K242317

Trade/Device Name: Integrated Endo System (Meet Endo-II) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC, EKX, EKR, LQY Dated: January 14, 2025 Received: January 14, 2025

Dear Chengfa Huang:

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/cdrh/cfdocs/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.

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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 (OS) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 medical devices and radiation-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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# MICHAEL E. ADJODHA -S

Michael 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

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### Indications for Use

Submission Number (if known)

K242317

Device Name

Integrated Endo System (Meet Endo-II)

Indications for Use (Describe)

The Integrated Endo System is dental device which combine in a single main control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The Integrated Endo System is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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### Section 5 - 510(k) Summary

K242317 Date of Summary Preparation: 08/05/2024 Date of Summary Revision: 01/14/2025

#### 1. Submitter's Identifications

Submitter's Name: DENJOY DENTAL CO., LTD Address: F4, Building A4, Lugu Medical Device Park, No.229, Guyuan Road, Changsha, 410205 P. R. China ZIP Code: 410205 Contact Person: Chengfa Huang Contact Title: Quality Manager Contact E-mail Address: [e-mail] Tel: [phone] Fax: [phone]

#### 2. Correspondent's Identifications

Correspondent's Name: Guangzhou Junyi Information Technology Co., Ltd. Address: Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town, Huangpu District, Guangzhou City, Guangdong, 510663, China ZIP Code: 510663 Contact Person: Jinghua Zhou Contact Title: Regulation Control Manager Contact E-mail Address: [e-mail] Telephone: [phone] Fax: [phone]

#### 3. Device Identification

Trade Name: Integrated Endo System Model: Meet Endo-II Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Common Name: Scaler, Ultrasonic Regulatory Class: Class II Product Code: ELC, Ultrasonic Scaler EKX, direct drive, AC-powered handpiece EKR, edodontic plugger, root canal LQY, root apex locator (unclassified) Review Panel: Dental

#### 4. Predicate Devices

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#### EndoPilot2 K202906

#### 5. Device Description

The Integrated Endo System Meet Endo-II is composed of Main Unit, Adapter, MeetMotor, MeetFill, MeetActivator. It is standalone AC-powered dental control units with a touch display screen to which multiple hand-held dental handpieces for root canal therapy procedure (MeetMotor is for root canal preparation, MeetFill is for root canal backfilling, MeetPex is for working length measurement of root canal, MeetActivator is for root canal irrigation).

These multifunctional devices are intended for use by professionals in the dental clinic use environment. Based on the modular concept of the Integrated Endo System different handpieces can be combined with the control unit. The key hand-held components like handpieces or endodontic tools of the Integrated Endo System are medical devices commercially available by themselves and have separate FDA registration or clearance for marketing in the US.

#### 6. Indications for Use

The Integrated Endo System is dental device which combine in a single main control unit an endo motor to clean the root canal, a dental obturator to fill and pressurize, an electronic apex locator to assist the operator to locate the file tip in the root canal and an ultrasonic-handpiece for root-canal cleaning and preparation.

The Integrated Endo System is intended solely for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.

#### 7. Substantial Equivalence Discussion

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#### Table 1 Comparison of Characteristic between Subject Device and Predicate Devices

| Attribute | Subject Device | Predicate Device | Device Comparison |
|-----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k number | K242317 | K202906 | ------ |
| Proprietary name | Integrated Endo<br>System | EndoPilot² | ------ |
| Model | Meet Endo-II | / | --------- |
| Manufacturer | DENJOY DENTAL<br>CO., LTD | Schlumbohm GmbH<br>& Co. KG | ------ |
| Regulation number<br>Regulation Name<br>Product Codes | 872.4200 Dental Handpiece and Accessories<br>EKX, direct drive, AC-powered handpiece<br>872.4565 Dental hand instrument<br>EKR, endodontic plugger, root canal<br>LQY, root apex locator (unclassified)<br>872.4850 Ultrasonic scaler<br>ELC Ultrasonic scaler | | Same |
| Regulatory Class | Class II | Class II | Same |
| Indications for use | The Integrated Endo<br>System is dental<br>device which combine<br>in a single main<br>control unit an endo<br>motor to clean the<br>root canal, a dental<br>obturator to fill and<br>pressurize, an<br>electronic apex<br>locator to assist the<br>operator to locate the<br>file tip in the root<br>canal and an<br>ultrasonic-handpiece<br>for root-canal<br>cleaning and<br>preparation.<br>The Integrated Endo<br>System is intended<br>solely for use by<br>trained dental<br>professionals in<br>professional health<br>care facilities on | The EndoPilot²<br>systems are dental<br>devices which<br>combine in a single<br>control unit an endo<br>motor to clean the<br>root canal, a dental<br>obturator to fill and<br>pressurize, an<br>electronic apex<br>locator to assist the<br>operator to locate the<br>file tip in the root<br>canal and an<br>ultrasonic-handpiece<br>for rootcanal cleaning<br>and preparation.<br>The EndoPilot² is<br>intended solely for use<br>by trained dental<br>professionals in<br>professional health<br>care facilities on<br>patients that need<br>root canal treatment | Same |
| | patients that need<br>root-canal-treatment. | | |
| Professional Use | Dental professionals | | Same |
| Location of Use | Dental practice | | Same |
| Mode of Action | Endo-Motor: ablates the tooth to clean the root<br>canal (rotating endo-files)<br>Obturation Unit: to fill and pressurize various<br>shaped packing elements (Warming up by a<br>resistance-wire)<br>Apex locator: to ensure the location of the front<br>tip in root canal through changes of electric<br>resistance value into one unit (Electrical<br>impedance)<br>Display: displayed through a single touch<br>screen | | Same |
| AC/DC<br>Power<br>Supply | AC: 100-240V,<br>50/60Hz<br>DC: 24V, 3A | AC: 100-240 V, 50/60<br>Hz<br>DC: 12 V, 1.5 A | Similar<br>DC difference results out<br>of the higher power<br>consumption for<br>Integrated Endo System<br>power adapters |
| Battery Operated | Yes, Li-Ion battery,<br>14.4V, 4800mAh,<br>69.12Wh | Yes, Li-Ion battery,<br>7.2V, power output<br>48Wh | Different<br>Battery tested for IEC<br>62133-2 |
| Components<br>for<br>system | 1) Main unit with<br>display panel (touch<br>screen), 5<br>connecting sockets,<br>power supply and<br>wireless charging<br>2) MeetPex (Probe<br>cable (single), Probe<br>cable (double), Extension<br>cable for hook, File<br>holder, Mouth hook,<br>Probe needle,<br>Locator)<br>3) MeetMotor<br>4) MeetFill<br>(D274830)<br>5) MeetActivator | 1) Control unit with<br>display panel (touch<br>screen), 5 connecting<br>sockets, a microSD slot,<br>power supply and<br>wireless footswitch<br>2) Apex cable set<br>(Lip-clip, Cap for<br>Lip-clip, Cable for file<br>clamp, File clamp,<br>Retainer for apex cable,<br>measuring cable)<br>3) Contra-angle for apex<br>measurement<br>4) Endodontic Motor<br>with apex measuring<br>contact<br>5) DownPack (D-Pack)<br>handpiece with LED | Similar<br>The small differences in<br>design do not raise new<br>questions of substantial<br>equivalence |
| | | indicator<br>6) BackFill handpiece<br>(K042828)<br>7) Ultrasonic handpiece,<br>Ultrasonic Module<br>(K050895) | |
| Processing (reuse of<br>components<br>sterilized by user) | To be reprocessed in the dental practice before<br>re-use. | | Similar<br>Manuals include<br>reprocessing instruction<br>based on ISO<br>17664-1/17665-1 |
| Electrical Safety | IEC 60601-1<br>IEC 80601-2-60 | IEC 60601-1<br>IEC 80601-2-60 | Same |
| Protection type and<br>level against electric<br>shock | Class I equipment,<br>Type BF applied<br>part | Class II equipment,<br>Type BF applied part | Similar<br>Equivalent technology is<br>used |
| Electromagnetic<br>Compatibility | IEC 60601-1-2<br>IEC TR 60601-4-2 | IEC 60601-1-2<br>IEC 61000-3 series<br>IEC 61000-4 series<br>(2,3,4,5,6,8,11) | Same<br>IEC<br>60601-1-2:2014+A1:2020<br>and IEC TR<br>60601-4-2:2016 tests of<br>subject device have<br>included the relevant<br>standards test of predicate<br>device. |
| | | Technological comparison of System Component Functions | |
| Main Unit and display, Apex cable set and foot switch | | | |
| Device Display<br>Function | LCD Touchscreen for<br>display of working<br>components | LCD Touchscreen for<br>display of working<br>components | Same |
| Functional<br>Specification | All main function can be selected directly at<br>the start screen<br>The device switches off after a longer period of<br>non-operation | | Same |
| Accessory Foot<br>Switch Function | None | Single wireless<br>footswitch or optional<br>Twin wireless<br>footswitch | Different<br>This difference does not<br>raise new questions |
| Wireless<br>connection/Bluetooth | 2400-2483.5 MHz,<br>TX Power: ≤ 20<br>dBm | 2.402-2.480 GHz, TX<br>Power: +7 dBm | Similar<br>The small differences in<br>design do not raise new<br>questions of substantial |
| | | | equivalence |

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| Attribute | Subject Device | Predicate Device | Device Comparison |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| 510k number | ------ | K202906 | ------ |
| Proprietary name | Integrated<br>Endo<br>System | EndoPilot² | ------ |
| Model | Meet Endo-II | / | ------ |
| Manufacturer | DENJOY DENTAL<br>CO., LTD | Schlumbohm GmbH<br>& Co. KG | ------ |
| Apex locator (Apex cable set) | | | |
| Function | Apex location of the front tip (of the endo-file)<br>in the root canal through changes of electric<br>resistance value | | Same |
| Apex locator | MeetPex | Electronic apex<br>locator (Schlumbohm) | Same |
| Apex<br>cable set<br>components<br>(material) | Probe cable (single &<br>double) (TPR Plastic<br>Class VI), Extension<br>cable for hook (TPR<br>Plastic Class VI), File<br>holder (Rubber),<br>Mouth hook (Stainless<br>steel), Probe needle<br>(Rubber, stainless<br>steel) | Lip clip<br>(Stainless-Steel)<br>cap for lip-clip plug<br>socket (POM-C)<br>58 mm 2mm<br>File clamp (USP<br>Plastic Class VI),<br>cable for file clamp<br>(TPR Plastic Class<br>VI)<br>Length 65 mm,<br>Diameter 12 mm<br>Measuring cable<br>(PVC), 1.5 m twin<br>cable<br>Retainer for apex<br>cable (Stainless steel)<br>(rest at the device) | Similar<br>Small difference in design<br>does not impact the<br>device |
| Functional<br>Specification | Accuracy of Apex<br>Locating point < ±0.5<br>mm | Accuracy of Apex<br>Locating point < ±0.5<br>mm | Same |
| Contra angle | | | |
| Function | holds the "drill bit" and/or endodontic files<br>used in endodontic procedures e.g. root canal<br>preparation | | Same |

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| Functional<br>Specification | 26*28*140mm,<br>Weight 128g<br>Torque range: Max. 5<br>Ncm +/- 10%<br>(Gear ratio: 6:1) | Ф20 x 94 mm, Weight<br>52.0g<br>Torque range: Max. 5<br>Ncm +/- 10%<br>(Gear ratio: 1:1) | Similar<br>Small difference in design<br>does not impact the<br>device |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Mode of Operation | Forward and reverse | | Same |
| Material | Aluminum | Hard chrome plated<br>brass | Different<br>The difference in design<br>does not impact the<br>device |
| Accessories<br>(Endo<br>Files) | Database with preset<br>values for parameters<br>for<br>selected<br>Endodontic Files from<br>File-manufacturers | Database with preset<br>values for parameters<br>for selected<br>Endodontic Files from<br>File-manufacturers | Same |

| Attribute | Subject Device | Predicate Device | Device Comparison |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| 510k number | ----- | K202906 | ----- |
| Proprietary name | Integrated Endo System | EndoPilot2 | ----- |
| Model | Meet Endo-II | / | ----- |
| Manufacturer | DENJOY DENTAL CO., LTD | Schlumbohm GmbH & Co. KG | ----- |
| Endodontic motor | | | |
| Function | Micro motor (dental handpiece) provides power<br>for contra angle to be used together in standard<br>endodontic procedures (root canal preparation) | | Same |
| Functional<br>Specification | 26*28*140mm<br>Weight 128g<br>(including wire)<br>File Rotation Speed:<br>100-1500 rpm<br>Torque limit value:<br>0.4-5.0 Ncm<br>Gear ratio: 6:1 (contra<br>angle)<br>Auto-reverse mode<br>Auto-stop mode<br>Speed Control<br>Torque Control | Φ21 x L 107 mm<br>Weight 132 g<br>(including wire)<br>File Rotation Speed:<br>200-1000 rpm<br>Torque limit value:<br>0.2-5.0 Ncm<br>Gear ratio 1: 1 (contra<br>angle)<br>Auto-reverse mode<br>Auto-stop mode<br>Speed Control<br>Torque control | Similar<br>Both rotation speed are<br>low speed ranges for<br>dental motors |
| Material | Stainless steel | Stainless steel | Same |

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| Obturation Unit Back (DownPack, BackFill handpiece, Gutta Percha) | | | |
|-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Function | fill and pressurize various shaped packing elements (Gutta percha) | | Same |
| Reference to FDA-cleared component | D274830, MeetFill, by DENJOY DENTAL CO., LTD | K042828, Obtura Heated Gutta Percha System, by YOUNG OS LLC | ---- |
| Functional Specification | MeetFill (D274830), 29*30*178mm, Weight 150g Working temperature:100-200°C ±10%, adjustable<br>Injection needle Diameter: 23 gauge, 24 gauge, 25 gauge Working length: 25.5 mm | Manual DownPack handpiece Φ14 x L 130.5 mm, weight 72 g Working temperature up to 300°C adjustable<br>Pack tip/heating tip (E & Q Master; elements free), FDA-registered by MetaBiomed<br>Manual BackFill handpiece (K042828) ΦHeating Unit 12.5 mm x 150.5 mm x 21.5 mm, Weight: 63g Working temperature up to 200°C, adjustable<br>BackFill Needles Diameter: 20 gauge, 23 gauge, 25 gauge working length 25.5 mm | Similar The difference in use is verified in the bench test |

| Attribute | Subject Device | Predicate Device | Device Comparison |
|------------------|------------------------|------------------|-------------------|
| 510k number | ------ | K202906 | ------ |
| Proprietary name | Integrated Endo System | EndoPilot2 | ------ |
| Model | Meet Endo-II | / | ------ |
| Manufacturer | DENJOY DENTAL | Schlumbohm GmbH | ------ |

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| | CO., LTD | & Co. KG | | | | Universal wrench for<br>ultrasonic tips<br>Ultrasonic handpiece<br>cable<br>Twin wireless foot<br>switch (Single<br>footswitch or optional<br>Twin-type) | |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Product Codes | ELC Ultrasonic Scaler | | Same | Intermittent<br>operation | None | 1 min/3 min<br>(endodontic treatment) | Different<br>The intermittent operation<br>is controlled by operator |
| Regulation Number<br>and<br>Regulation<br>Name | 872.4850 Ultrasonic Scaler | | Same | Vibration frequency | 45±10kHz | 27 to 33 kHz | Different<br>This difference does not<br>raise new questions |
| Indications for use | The Integrated Endo<br>System is dental<br>device which combine<br>in a single main<br>control unit an endo<br>motor to clean the root<br>canal, a dental<br>obturator to fill and<br>pressurize, an<br>electronic apex locator<br>to assist the operator<br>to locate the file tip in<br>the root canal and an<br>ultrasonic-handpiece<br>for root-canal cleaning<br>and preparation.<br>The Integrated Endo<br>System is intended<br>solely for use by<br>trained dental<br>professionals in<br>professional health<br>care facilities on<br>patients that need<br>root-canal-treatment. | The EndoPilot² systems are dental<br>devices which<br>combine in a single<br>control unit an endo<br>motor to clean the root<br>canal, a dental<br>obturator to fill and<br>pressurize, an<br>electronic apex locator<br>to assist the operator<br>to locate the file tip in<br>the root canal and an<br>ultrasonic-handpiece<br>for rootcanal cleaning<br>and preparation.<br>The EndoPilot² is<br>intended solely for use<br>by trained dental<br>professionals in<br>professional health<br>care facilities on<br>patients that need<br>root-canal-treatment. | Same | Activation | By Power switch,<br>Start/Stop button | By footswitch,<br>ON/OFF button | Different<br>This difference does not<br>raise new questions |
| Components | Control-Unit:<br>Meet Endo-II main<br>unit with integrated<br>ultrasonic module with<br>connecting soket.<br>Ultrasonic handpiece:<br>Main handpiece<br>Activator working tip<br>Silicone sleeve | Control-Unit:<br>EndoPilot² unit with<br>integrated ultrasonic<br>module with<br>connecting socket.<br>(the ultrasonic module<br>is identical to<br>SUPRASSON SP<br>NEWTRON-module)<br>Ultrasonic handpiece:<br>Handpiece<br>(SUPRASSON<br>SPNEWTRON) | Similar<br>The same ultrasonic<br>module is used. The<br>difference in use of the<br>ultrasonic module result<br>out of the connection to<br>the Meet Endo-II | Cleaning,<br>disinfection,<br>sterilization | ISO 17664-1<br>ISO 17665-1 | ISO 17664<br>ISO 17665-1 | Same |
| AC/DC Power<br>supply | Battery:<br>3.7V,<br>1200mAh…