(265 days)
No
The document describes a standard ultrasonic device for root canal cleaning and preparation, with no mention of AI or ML capabilities in the device description, intended use, or performance studies.
Yes
The device is used for root canal cleaning and preparation, which is a therapeutic intervention to treat a medical condition.
No
The device is described as an "auxiliary device for dentists to perform root canal treatment" and is "mainly used to clean the root canal with the help of ultrasonic cavitation." Its intended use is for "root canal cleaning and preparation," which are therapeutic or interventional actions, not diagnostic ones. There is no mention of it being used to identify or assess a condition.
No
The device description explicitly lists multiple hardware components, including an ultrasonic handpiece, working tip, wrench, silicone case, charging base, power adapter, and optional wireless foot switch. This indicates it is a physical device with accompanying hardware, 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 is for "root canal cleaning and preparation" and "to clean the root canal with the help of ultrasonic cavitation." This is a therapeutic and procedural use within the body (in vivo), not for examining specimens taken from the body (in vitro) to diagnose or monitor a condition.
- Device Description: The description details a handpiece, tips, and accessories used directly on the patient's tooth/root canal.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, or controls, which are typical components and uses of IVD devices.
Therefore, the Ultrasonic Endo Activation Device (Model: Actor I pro) is a medical device used for a dental procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ultrasonic Endo Activation Device (Model:Actor I pro ) is an ultrasonic-handpiece which is intended use for rootcanal cleaning and preparation.
The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.
Product codes
ELC
Device Description
The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) is an auxiliary device for dentists to perform root canal treatment. It is mainly used to clean the root canal with the help of ultrasonic cavitation, so as to assist dentists to complete root canal treatment.
The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) configuration consist of the following components:
(1) ultrasonic handpiece (2) ultrasonic working tip (3) Wrench (4) silicone case (5) charging base
(6) Power Adapter(7) wireless foot switch (Optional)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canal
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)
Clinical test:
Clinical testing is not required.
Non-clinical data
The proposed device Ultrasonic Endo Activation Device (Model: Actor I pro) complies with: Safety and performance:
IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements ー for basic safety and essential performance.
IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for 2. the basic safety and essential performance of dental equipment
Usability
IEC 60601-1-6:2013 Medical electrical equipment - Part 1-6: General requirements for basic 3. safety and essential performance - Collateral standard: Usability
Electromagnetic Compatibility:
IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests
Biocompatibility:
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation 5. and skin sensitization
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Software Verification and Validation:
FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".
Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Cleaning, intermediate level Disinfection, and Sterilization of the components of the subject
device per the FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2.
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is substantially equivalent to the legally marketed predicated device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
September 8, 2022
ChangZhou BoMedent Medical Technology Co.,Ltd Yang Chunyuan Sales Manager No.9 Changyang Road.West Taihu Science & Technology Industrial Park Changzhou, Jiangsu 213100 China
Re: K213947
Trade/Device Name: Ultrasonic Endo Activation Device (Model:Actor I pro) Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: August 11, 2022 Received: August 12, 2022
Dear Yang Chunyuan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
For Michael E. Adjodha, M.ChE. 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
2
Indications for Use
510(k) Number (if known) K213947
Device Name
Ultrasonic Endo Activation Device (Model:Actor I pro )
Indications for Use (Describe)
The Ultrasonic Endo Activation Device (Model:Actor I pro ) is an ultrasonic-handpiece which is intended use for rootcanal cleaning and preparation.
The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended 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)
| X Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/1 description: The image shows the logo for BOMEDENT. The logo consists of a stylized graphic to the left of the company name. The graphic is composed of two angled shapes, one in gray and the other in yellow. The company name, "BOMEDENT," is written in gray, sans-serif capital letters.
510(K) Summary K213947
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: September 6, 2022
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | ChangZhou BoMedent Medical Technology Co.,Ltd |
|---|---|
| Address: | No.9 Changyang Road,West Taihu Science & Technology |
| Industrial Park, Changzhou, Jiangsu China. | |
| Contact person: | Yang Chunyuan |
| Title: | sales manager |
| E-mail: | yang.chunyuan@bome-dent.com |
| Tel: | +86-15161150269 |
2. Device Identification
| Trade/Device Name: | Ultrasonic Endo Activation Device |
|---|---|
| Models: | Actor I pro |
| Common name: | Scaler, Ultrasonic |
| Regulation Number: | 21 CFR 872.4850 |
| Regulation Name: | Ultrasonic scaler |
| Regulation Class: | Class II |
| Panel: | Dental |
| Product Code: | ELC |
3. Predicate Device
| 510(K) number: | K202906 |
|---|---|
| Device Name: | EndoPilot² |
| Manufacturer: | Schlumbohm GmbH & Co. KG |
| Common name | Dental hand instrument |
| Regulation Number: | 21 CFR 872.4850 |
| Regulation Name: | Ultrasonic Scaler |
| Regulation Class: | Class II |
| Panel: | Dental |
| Product Code: | ELC Ultrasonic scaler |
| EKX direct drive, AC-powered handpiece | |
| EKR endodontic plugger, root canal | |
| LQY root apex locator (unclassified) |
4
Image /page/4/Picture/1 description: The image shows the logo for BOMEDENT. The logo consists of two overlapping rectangles, one gray and one yellow, followed by the text "BOMEDENT" in gray. The rectangles are oriented diagonally, with the gray rectangle slightly above and to the left of the yellow rectangle. The text is in a sans-serif font and is aligned to the right of the rectangles.
4. Device Description
The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) is an auxiliary device for dentists to perform root canal treatment. It is mainly used to clean the root canal with the help of ultrasonic cavitation, so as to assist dentists to complete root canal treatment.
The subject device Ultrasonic Endo Activation Device (Model: Actor I pro) configuration consist of the following components:
(1) ultrasonic handpiece (2) ultrasonic working tip (3) Wrench (4) silicone case (5) charging base
(6) Power Adapter(7) wireless foot switch (Optional)
5. Indication for use
The Ultrasonic Endo Activation Device (Model:Actor I pro ) is an ultrasonic-handpiece which is intended use for root-canal cleaning and preparation.
The Ultrasonic Endo Activation Device (Model:Actor I pro ) is intended for use by trained dental professionals in professional health care facilities on patients that need root-canal-treatment.
6. Summary of the device compared to the predicate device
Compared to the predicate device, the subject device has the same intended use, similar product design, same performance as the predicate device, summarized comparison information is listed in the following table:
| SE
Comparisons | Subject Devices | Predicate Device
K202906 | Similarities/Differences |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | The Ultrasonic Endo
Activation Device
(Model:Actor I pro ) is an
ultrasonic-handpiece which
is intended use for root-
canal cleaning and
preparation.
The Ultrasonic Endo
Activation Device
(Model:Actor I pro ) is
intended for use by trained
dental professionals in
professional health care
facilities on patients that
need root-canal-treatment. | 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 root-canal
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. | Similar
Predicate device includes
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 root-canal
cleaning and
preparation.
But Proposed device
only include ultrasonic-
handpiece which is
intended use for root-
canal cleaning and
preparation.
Function of proposed |
| | | | device is one of the
functions of predicate
device, there is no risk
arise in aspect of
indication for use. |
| Intermittent
operation | 3min | 1 min/3 min (endodontic
treatment) | Similar
Subject device only has
one mode, it can work
for 3 minutes
continuously.
No new risk raised. |
| Vibration
frequency | $30\pm3$ kHz(27-33 kHz) | 27 to 33 kHz | Same |
| Activation | By footswitch (optional),
ON/OFF button | By footswitch, ON/OFF
button | same |
| Patient
contacting
components | Ultrasonic working tip | Ultrasonic working tip | same |
| Power supply | Rechargeable Li-ion
battery
Capacity 1600mAh,3.7V | / | Different
The subject device
powered by a
rechargeable Li-ion
battery. The safety test
results show no new
safety risk raised. |
| Charger | Input: AC100-240V,
50/60Hz 0.2A
Output: DC5V/1A | AC: 100-240 V, 50/60 Hz
DC: 12 V, 1.5 A | Similar
testing shows no new
question raised |
| Bluetooth | BLE 5.0 | 4.1 Bluetooth | Different
Meet EMC standard and
FCC |
| Sterilization | Working Tip, Wrench and
Silicone Case are user
sterilized by
steam sterilization. | handpiece and the tool are
user sterilized by
steam sterilization | Same |
| Electrical
Safety | IEC 60601-1:2012
IEC 80601-2-60:2019 | IEC 60601-1:2012
IEC 80601-2-60:2019 | same |
| EMC | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | same |
| Biocompatibility | ISO 10993-5:2009
ISO 10993-10:2010
ISO 10993-11:2017 | ISO 10993-5:2009
ISO 10993-10:2010 | We conducted the acute
systemic toxicity testing
and pyrogen testing, test
results show no
biocompatibility risk. |
5
Image /page/5/Picture/1 description: The image shows the logo for BOMEDENT. The logo consists of a stylized graphic to the left of the company name. The graphic is made up of three angled bars, two in gray and one in yellow. The company name, "BOMEDENT", is in gray, sans-serif font.
6
Image /page/6/Picture/1 description: The image shows the logo for BOMEDENT. The logo consists of two overlapping rectangles, one gray and one yellow, that are tilted to the left. To the right of the rectangles is the word "BOMEDENT" in gray, block letters. The logo is simple and modern.
All the differences don't affect substantial equivalence which is concluded after all the required testing.
8. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The proposed device Ultrasonic Endo Activation Device (Model: Actor I pro) complies with: Safety and performance:
IEC 60601-1:2005+A1:2012 Medical electrical equipment – Part 1: General requirements ー for basic safety and essential performance.
IEC 80601-2-60:2012 Medical electrical equipment - Part 2-60: Particular requirements for 2. the basic safety and essential performance of dental equipment
Usability
IEC 60601-1-6:2013 Medical electrical equipment - Part 1-6: General requirements for basic 3. safety and essential performance - Collateral standard: Usability
Electromagnetic Compatibility:
IEC 60601-1-2:2014 Medical electrical equipment-Part1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromagnetic disturbances-Requirements and tests
Biocompatibility:
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation 5. and skin sensitization
-
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
Software Verification and Validation:
FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".
Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Cleaning, intermediate level Disinfection, and Sterilization of the components of the subject
7
Image /page/7/Picture/1 description: The image shows the logo for BOMEDENT. The logo consists of two angled rectangles, one gray and one yellow, followed by the text "BOMEDENT" in gray. The rectangles are positioned to the left of the text, with the yellow rectangle slightly overlapping the gray one. The text is in a sans-serif font and is aligned horizontally.
device per the FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, AAMI TIR 30, AAMI TIR 12, ISO 17665-1, and ISO17665-2.
9. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is substantially equivalent to the legally marketed predicated device.