(192 days)
No
The summary describes a system combining standard dental tools (endo motor, obturator, apex locator, ultrasonic handpiece) with a control unit. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The performance studies focus on standard device safety and functionality testing.
Yes
The device is described as assisting in root canal treatment, which is a medical procedure aimed at restoring health to a tooth. It performs functions like cleaning, filling, and locating portions of the root canal, all of which directly modify bodily functions and structure for therapeutic purposes.
Yes
The device includes an "electronic apex locator to assist the operator to locate the file tip in the root canal" and "MeetPex is for working length measurement of root canal", which are diagnostic functions.
No
The device description explicitly lists multiple hardware components (Main Unit, Adapter, MeetMotor, MeetFill, MeetActivator, hand-held dental handpieces) and describes them as standalone AC-powered units with a touch display. It also mentions electrical safety, electromagnetic compatibility, and wireless coexistence testing, which are relevant to hardware. While software verification and validation are mentioned, the device is clearly not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "cleaning the root canal," "filling and pressurizing," "locating the file tip in the root canal," and "root-canal cleaning and preparation." These are all procedures performed directly on the patient's body (in vivo) within the root canal.
- Device Description: The description reinforces that the device is a "standalone AC-powered dental control unit" with "multiple hand-held dental handpieces for root canal therapy procedure." The components are described as being used for "root canal preparation," "root canal backfilling," "working length measurement of root canal," and "root canal irrigation." Again, these are all in-vivo procedures.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or other bodily fluids) outside of the body to provide information about a physiological state, health, or disease. This is the core definition of an IVD.
The device is a medical device used for dental procedures performed directly on the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ELC, EKX, EKR, LQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canal (dental)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained dental professionals in professional health care facilities.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Performed:
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
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.
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 (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
2
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
3
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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4
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
5
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
6
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 | ||
| System | EndoPilot² | ------ | |
| Model | Meet Endo-II | / | --------- |
| Manufacturer | DENJOY DENTAL | ||
| CO., LTD | Schlumbohm GmbH | ||
| & Co. KG | ------ | ||
| Regulation number | |||
| Regulation Name | |||
| Product Codes | 872.4200 Dental Handpiece and Accessories | ||
| EKX, direct drive, AC-powered handpiece | |||
| 872.4565 Dental hand instrument | |||
| EKR, endodontic plugger, root canal | |||
| LQY, root apex locator (unclassified) | |||
| 872.4850 Ultrasonic scaler | |||
| ELC Ultrasonic scaler | Same | ||
| Regulatory Class | Class II | Class II | Same |
| 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 | The EndoPilot² | ||
| systems are dental | |||
| devices which | |||
| combine in a single | |||
| 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 rootcanal cleaning | |||
| and preparation. | |||
| The EndoPilot² is | |||
| intended solely for use | |||
| by trained dental | |||
| professionals in | |||
| professional health | |||
| care facilities on | |||
| patients that need | |||
| root canal treatment | Same | ||
| patients that need | |||
| 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 | ||
| canal (rotating endo-files) | |||
| Obturation Unit: to fill and pressurize various | |||
| shaped packing elements (Warming up by a | |||
| resistance-wire) | |||
| Apex locator: to ensure the location of the front | |||
| tip in root canal through changes of electric | |||
| resistance value into one unit (Electrical | |||
| impedance) | |||
| Display: displayed through a single touch | |||
| screen | Same | ||
| AC/DC | |||
| Power | |||
| Supply | AC: 100-240V, | ||
| 50/60Hz | |||
| DC: 24V, 3A | AC: 100-240 V, 50/60 | ||
| Hz | |||
| DC: 12 V, 1.5 A | Similar | ||
| DC difference results out | |||
| of the higher power | |||
| consumption for | |||
| Integrated Endo System | |||
| power adapters | |||
| Battery Operated | Yes, Li-Ion battery, | ||
| 14.4V, 4800mAh, | |||
| 69.12Wh | Yes, Li-Ion battery, | ||
| 7.2V, power output | |||
| 48Wh | Different | ||
| Battery tested for IEC | |||
| 62133-2 | |||
| Components | |||
| for | |||
| system | 1) Main unit with | ||
| display panel (touch | |||
| screen), 5 | |||
| connecting sockets, | |||
| power supply and | |||
| wireless charging |
- MeetPex (Probe
cable (single), Probe
cable (double), Extension
cable for hook, File
holder, Mouth hook,
Probe needle,
Locator) - MeetMotor
- MeetFill
(D274830) - MeetActivator | 1) Control unit with
display panel (touch
screen), 5 connecting
sockets, a microSD slot,
power supply and
wireless footswitch - Apex cable set
(Lip-clip, Cap for
Lip-clip, Cable for file
clamp, File clamp,
Retainer for apex cable,
measuring cable) - Contra-angle for apex
measurement - Endodontic Motor
with apex measuring
contact - DownPack (D-Pack)
handpiece with LED | Similar
The small differences in
design do not raise new
questions of substantial
equivalence |
| | | indicator - BackFill handpiece
(K042828) - Ultrasonic handpiece,
Ultrasonic Module
(K050895) | |
| Processing (reuse of
components
sterilized by user) | To be reprocessed in the dental practice before
re-use. | | Similar
Manuals include
reprocessing instruction
based on ISO
17664-1/17665-1 |
| Electrical Safety | IEC 60601-1
IEC 80601-2-60 | IEC 60601-1
IEC 80601-2-60 | Same |
| Protection type and
level against electric
shock | Class I equipment,
Type BF applied
part | Class II equipment,
Type BF applied part | Similar
Equivalent technology is
used |
| Electromagnetic
Compatibility | IEC 60601-1-2
IEC TR 60601-4-2 | IEC 60601-1-2
IEC 61000-3 series
IEC 61000-4 series
(2,3,4,5,6,8,11) | Same
IEC
60601-1-2:2014+A1:2020
and IEC TR
60601-4-2:2016 tests of
subject device have
included the relevant
standards test of predicate
device. |
| | | Technological comparison of System Component Functions | |
| Main Unit and display, Apex cable set and foot switch | | | |
| Device Display
Function | LCD Touchscreen for
display of working
components | LCD Touchscreen for
display of working
components | Same |
| Functional
Specification | All main function can be selected directly at
the start screen
The device switches off after a longer period of
non-operation | | Same |
| Accessory Foot
Switch Function | None | Single wireless
footswitch or optional
Twin wireless
footswitch | Different
This difference does not
raise new questions |
| Wireless
connection/Bluetooth | 2400-2483.5 MHz,
TX Power: ≤ 20
dBm | 2.402-2.480 GHz, TX
Power: +7 dBm | Similar
The small differences in
design do not raise new
questions of substantial |
| | | | equivalence |
7
8
9
| 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 | ------ | ||
| Apex locator (Apex cable set) | |||
| Function | Apex location of the front tip (of the endo-file) | ||
| in the root canal through changes of electric | |||
| resistance value | Same | ||
| Apex locator | MeetPex | Electronic apex | |
| locator (Schlumbohm) | Same | ||
| Apex | |||
| cable set | |||
| components | |||
| (material) | Probe cable (single & | ||
| double) (TPR Plastic | |||
| Class VI), Extension | |||
| cable for hook (TPR | |||
| Plastic Class VI), File | |||
| holder (Rubber), | |||
| Mouth hook (Stainless | |||
| steel), Probe needle | |||
| (Rubber, stainless | |||
| steel) | Lip clip | ||
| (Stainless-Steel) | |||
| cap for lip-clip plug | |||
| socket (POM-C) | |||
| 58 mm 2mm | |||
| File clamp (USP | |||
| Plastic Class VI), | |||
| cable for file clamp | |||
| (TPR Plastic Class | |||
| VI) | |||
| Length 65 mm, | |||
| Diameter 12 mm | |||
| Measuring cable | |||
| (PVC), 1.5 m twin | |||
| cable | |||
| Retainer for apex | |||
| cable (Stainless steel) | |||
| (rest at the device) | Similar | ||
| Small difference in design | |||
| does not impact the | |||
| device | |||
| Functional | |||
| Specification | Accuracy of Apex | ||
| Locating point |