(192 days)
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.
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.
The provided document describes a 510(k) premarket notification for the "Integrated Endo System (Meet Endo-II)". This submission is for a dental device, not an AI/ML medical device, and therefore, the information typically found in an AI/ML acceptance criteria and study report (e.g., specific metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication, MRMC studies) is not present.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (EndoPilot2 K202906) through non-clinical performance testing, electrical safety, biocompatibility, and software validation for a "Moderate Level of Concern" software. It is a comparison of technological characteristics and safety standards rather than a performance study on a diagnostic or pattern-recognition AI/ML algorithm.
Therefore, I cannot extract the requested information regarding AI/ML acceptance criteria and study details from this document. The document confirms that the device meets various electrical, safety, and performance standards relevant to general medical devices and integrates several dental functions, but it does not describe a study involving an AI/ML algorithm's diagnostic performance.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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: 271516734@gq.com Tel: +86-731-85126543 Fax: +86-731-88885317
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: admanzhou@126.com Telephone: +86-20-82329549 Fax: +86-20-82329549
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 EndoSystem | EndoPilot² | ------ |
| Model | Meet Endo-II | / | --------- |
| Manufacturer | DENJOY DENTALCO., LTD | Schlumbohm GmbH& Co. KG | ------ |
| Regulation numberRegulation NameProduct Codes | 872.4200 Dental Handpiece and AccessoriesEKX, direct drive, AC-powered handpiece872.4565 Dental hand instrumentEKR, endodontic plugger, root canalLQY, root apex locator (unclassified)872.4850 Ultrasonic scalerELC Ultrasonic scaler | Same | |
| Regulatory Class | Class II | Class II | Same |
| Indications for use | The Integrated EndoSystem is dentaldevice which combinein a single maincontrol unit an endomotor to clean theroot canal, a dentalobturator to fill andpressurize, anelectronic apexlocator to assist theoperator to locate thefile tip in the rootcanal and anultrasonic-handpiecefor root-canalcleaning andpreparation.The Integrated EndoSystem is intendedsolely for use bytrained dentalprofessionals inprofessional healthcare facilities on | The EndoPilot²systems are dentaldevices whichcombine in a singlecontrol unit an endomotor to clean theroot canal, a dentalobturator to fill andpressurize, anelectronic apexlocator to assist theoperator to locate thefile tip in the rootcanal and anultrasonic-handpiecefor rootcanal cleaningand preparation.The EndoPilot² isintended solely for useby trained dentalprofessionals inprofessional healthcare facilities onpatients that needroot canal treatment | Same |
| patients that needroot-canal-treatment. | |||
| Professional Use | Dental professionals | Same | |
| Location of Use | Dental practice | Same | |
| Mode of Action | Endo-Motor: ablates the tooth to clean the rootcanal (rotating endo-files)Obturation Unit: to fill and pressurize variousshaped packing elements (Warming up by aresistance-wire)Apex locator: to ensure the location of the fronttip in root canal through changes of electricresistance value into one unit (Electricalimpedance)Display: displayed through a single touchscreen | Same | |
| AC/DCPowerSupply | AC: 100-240V,50/60HzDC: 24V, 3A | AC: 100-240 V, 50/60HzDC: 12 V, 1.5 A | SimilarDC difference results outof the higher powerconsumption forIntegrated Endo Systempower adapters |
| Battery Operated | Yes, Li-Ion battery,14.4V, 4800mAh,69.12Wh | Yes, Li-Ion battery,7.2V, power output48Wh | DifferentBattery tested for IEC62133-2 |
| Componentsforsystem | 1) Main unit withdisplay panel (touchscreen), 5connecting sockets,power supply andwireless charging2) MeetPex (Probecable (single), Probecable (double), Extensioncable for hook, Fileholder, Mouth hook,Probe needle,Locator)3) MeetMotor4) MeetFill(D274830)5) MeetActivator | 1) Control unit withdisplay panel (touchscreen), 5 connectingsockets, a microSD slot,power supply andwireless footswitch2) Apex cable set(Lip-clip, Cap forLip-clip, Cable for fileclamp, File clamp,Retainer for apex cable,measuring cable)3) Contra-angle for apexmeasurement4) Endodontic Motorwith apex measuringcontact5) DownPack (D-Pack)handpiece with LED | SimilarThe small differences indesign do not raise newquestions of substantialequivalence |
| indicator6) BackFill handpiece(K042828)7) Ultrasonic handpiece,Ultrasonic Module(K050895) | |||
| Processing (reuse ofcomponentssterilized by user) | To be reprocessed in the dental practice beforere-use. | SimilarManuals includereprocessing instructionbased on ISO17664-1/17665-1 | |
| Electrical Safety | IEC 60601-1IEC 80601-2-60 | IEC 60601-1IEC 80601-2-60 | Same |
| Protection type andlevel against electricshock | Class I equipment,Type BF appliedpart | Class II equipment,Type BF applied part | SimilarEquivalent technology isused |
| ElectromagneticCompatibility | IEC 60601-1-2IEC TR 60601-4-2 | IEC 60601-1-2IEC 61000-3 seriesIEC 61000-4 series(2,3,4,5,6,8,11) | SameIEC60601-1-2:2014+A1:2020and IEC TR60601-4-2:2016 tests ofsubject device haveincluded the relevantstandards test of predicatedevice. |
| Technological comparison of System Component Functions | |||
| Main Unit and display, Apex cable set and foot switch | |||
| Device DisplayFunction | LCD Touchscreen fordisplay of workingcomponents | LCD Touchscreen fordisplay of workingcomponents | Same |
| FunctionalSpecification | All main function can be selected directly atthe start screenThe device switches off after a longer period ofnon-operation | Same | |
| Accessory FootSwitch Function | None | Single wirelessfootswitch or optionalTwin wirelessfootswitch | DifferentThis difference does notraise new questions |
| Wirelessconnection/Bluetooth | 2400-2483.5 MHz,TX Power: ≤ 20dBm | 2.402-2.480 GHz, TXPower: +7 dBm | SimilarThe small differences indesign do not raise newquestions of substantial |
| equivalence |
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| Attribute | Subject Device | Predicate Device | Device Comparison |
|---|---|---|---|
| 510k number | ------ | K202906 | ------ |
| Proprietary name | IntegratedEndoSystem | EndoPilot² | ------ |
| Model | Meet Endo-II | / | ------ |
| Manufacturer | DENJOY DENTALCO., LTD | Schlumbohm GmbH& Co. KG | ------ |
| Apex locator (Apex cable set) | |||
| Function | Apex location of the front tip (of the endo-file)in the root canal through changes of electricresistance value | Same | |
| Apex locator | MeetPex | Electronic apexlocator (Schlumbohm) | Same |
| Apexcable setcomponents(material) | Probe cable (single &double) (TPR PlasticClass VI), Extensioncable for hook (TPRPlastic Class VI), Fileholder (Rubber),Mouth hook (Stainlesssteel), Probe needle(Rubber, stainlesssteel) | Lip clip(Stainless-Steel)cap for lip-clip plugsocket (POM-C)58 mm 2mmFile clamp (USPPlastic Class VI),cable for file clamp(TPR Plastic ClassVI)Length 65 mm,Diameter 12 mmMeasuring cable(PVC), 1.5 m twincableRetainer for apexcable (Stainless steel)(rest at the device) | SimilarSmall difference in designdoes not impact thedevice |
| FunctionalSpecification | Accuracy of ApexLocating point < ±0.5mm | Accuracy of ApexLocating point < ±0.5mm | Same |
| Contra angle | |||
| Function | holds the "drill bit" and/or endodontic filesused in endodontic procedures e.g. root canalpreparation | Same |
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| FunctionalSpecification | 2628140mm,Weight 128gTorque range: Max. 5Ncm +/- 10%(Gear ratio: 6:1) | Ф20 x 94 mm, Weight52.0gTorque range: Max. 5Ncm +/- 10%(Gear ratio: 1:1) | SimilarSmall difference in designdoes not impact thedevice |
|---|---|---|---|
| Mode of Operation | Forward and reverse | Same | |
| Material | Aluminum | Hard chrome platedbrass | DifferentThe difference in designdoes not impact thedevice |
| Accessories(EndoFiles) | Database with presetvalues for parametersforselectedEndodontic Files fromFile-manufacturers | Database with presetvalues for parametersfor selectedEndodontic Files fromFile-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 powerfor contra angle to be used together in standardendodontic procedures (root canal preparation) | Same | |
| FunctionalSpecification | 2628140mmWeight 128g(including wire)File Rotation Speed:100-1500 rpmTorque limit value:0.4-5.0 NcmGear ratio: 6:1 (contraangle)Auto-reverse modeAuto-stop modeSpeed ControlTorque Control | Φ21 x L 107 mmWeight 132 g(including wire)File Rotation Speed:200-1000 rpmTorque limit value:0.2-5.0 NcmGear ratio 1: 1 (contraangle)Auto-reverse modeAuto-stop modeSpeed ControlTorque control | SimilarBoth rotation speed arelow speed ranges fordental 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), 2930178mm, Weight 150g Working temperature:100-200°C ±10%, adjustableInjection 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 adjustablePack tip/heating tip (E & Q Master; elements free), FDA-registered by MetaBiomedManual BackFill handpiece (K042828) ΦHeating Unit 12.5 mm x 150.5 mm x 21.5 mm, Weight: 63g Working temperature up to 200°C, adjustableBackFill 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 forultrasonic tipsUltrasonic handpiececableTwin wireless footswitch (Singlefootswitch or optionalTwin-type) | |||||
|---|---|---|---|---|---|---|---|
| Product Codes | ELC Ultrasonic Scaler | Same | Intermittentoperation | None | 1 min/3 min(endodontic treatment) | DifferentThe intermittent operationis controlled by operator | |
| Regulation NumberandRegulationName | 872.4850 Ultrasonic Scaler | Same | Vibration frequency | 45±10kHz | 27 to 33 kHz | DifferentThis difference does notraise new questions | |
| Indications for use | The Integrated EndoSystem is dentaldevice which combinein a single maincontrol unit an endomotor to clean the rootcanal, a dentalobturator to fill andpressurize, anelectronic apex locatorto assist the operatorto locate the file tip inthe root canal and anultrasonic-handpiecefor root-canal cleaningand preparation.The Integrated EndoSystem is intendedsolely for use bytrained dentalprofessionals inprofessional healthcare facilities onpatients that needroot-canal-treatment. | The EndoPilot² systems are dentaldevices whichcombine in a singlecontrol unit an endomotor to clean the rootcanal, a dentalobturator to fill andpressurize, anelectronic apex locatorto assist the operatorto locate the file tip inthe root canal and anultrasonic-handpiecefor rootcanal cleaningand preparation.The EndoPilot² isintended solely for useby trained dentalprofessionals inprofessional healthcare facilities onpatients that needroot-canal-treatment. | Same | Activation | By Power switch,Start/Stop button | By footswitch,ON/OFF button | DifferentThis difference does notraise new questions |
| Components | Control-Unit:Meet Endo-II mainunit with integratedultrasonic module withconnecting soket.Ultrasonic handpiece:Main handpieceActivator working tipSilicone sleeve | Control-Unit:EndoPilot² unit withintegrated ultrasonicmodule withconnecting socket.(the ultrasonic moduleis identical toSUPRASSON SPNEWTRON-module)Ultrasonic handpiece:Handpiece(SUPRASSONSPNEWTRON) | SimilarThe same ultrasonicmodule is used. Thedifference in use of theultrasonic module resultout of the connection tothe Meet Endo-II | Cleaning,disinfection,sterilization | ISO 17664-1ISO 17665-1 | ISO 17664ISO 17665-1 | Same |
| AC/DC Powersupply | Battery:3.7V,1200mAh | AC: 100-240 V, 50/60HzDC: 12 V, 1.5 A | DifferentThe intermittent operationis controlled by operator | ||||
| WirelessConnectionfootswitch | None | 4.1 Bluetooth | DifferentThe intermittent operationis controlled by operator | ||||
| Electrical Safety | IEC 60601-1IEC 80601-2-60 | IEC 60601-1IEC 80601-2-60 | Same | ||||
| ElectromagneticCompatibility (EC) | IEC 60601-1-2IEC TR 60601-4-2 | IEC 60601-1-2IEC 61000-3 seriesIEC 61000-4 series(2,3,4,5,6,8,11) | SameIEC60601-1-2:2014+A1:2020and IEC TR60601-4-2:2016 tests ofsubject device haveincluded the relevantstandards test of predicatedevice. |
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8. Non-Clinical Tests Performed:
To demonstrate the performance of Integrated Endo System and to show substantial equivalence to the predicate device, DENJOY DENTAL CO., LTD completed a number of non-clinical performance tests. Results confirm that the design inputs, function and performance specifications for the device are met. The Integrated Endo System systems passed the testing in accordance with internal requirements, national
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standards, and international standards shown below, supporting its performance, and its substantial equivalence to the predicate device.
The following non-clinical testing was provided in this 510(k):
Biocompatibility evaluation per ISO 10993-1 assessed the risk biocompatibility for in vitro cytotoxicity, skin sensitization, and oral mucosa irritation to ISO 10993-5, 10, 23. All tests passed.
Electrical Safety Testing per IEC 60601-1 AND IEC 80601-2-60, PASSED required testing.
Electromagnetic Compatibility Testing per IEC 60601-1-2, IEC TR 60601-4-2, PASSED required testing.
Wireless Coexistence Testing per ANSI/USEMCSC C63.27, AAMI TIR 69, and FCC CFR Title 47 Part 15 Subpart C Section 15.247, PASSED required testing.
Reprocessing validation (cleaning and sterilization) per the FDA Guidance Document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling".
Coupling between handpieces and motors connected to dental units follows ISO 3964 and ISO 14457; all specifications dimension, tolerances and the extraction force requirements were met.
Software verification and validation testing has been completed on a functional level for a Moderate Level of Concern software including system compatibility testing, risk analysis per IEC 62304 and FDA Guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, Guidance for Industry and Food and Drug Administration Staff" to address possible hazards, mitigations, and design considerations pertaining to intentional and unintentional cybersecurity risks associated with the device, PASSED required testing.
Usability engineering testing per IEC 62336-1, Testing of 15 participants was conducted showing that the participants were able to understand the user manual and labeling and were able to safely and effectively use the device.
10. Conclusion
The Integrated Endo System (model Meet Endo-II) has the same indications for use as the predicate device K202906 EndoPilot*. Any minor differences in the technological characteristics of the subject device when compared to the predicate devices have been successfully evaluated through appropriate performance testing which demonstrates that the subject device, when compared to the predicate device, does not raise any new questions of substantial equivalence. Therefore, the Integrated Endo System (model Meet Endo-II) has been determined to be substantially equivalent to predicate device K202906 EndoPilot2.
§ 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.