(214 days)
No
The description details a mechanical device for cleaning and polishing teeth with speed control options, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
This device is intended for cleaning and polishing teeth, which are general hygiene procedures and not considered therapeutic interventions for treating diseases or conditions.
No
The device is a handpiece used for cleaning and polishing teeth, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly details multiple hardware components including a cordless handpiece, charging station, wireless foot control, and accessories. While software is mentioned for validation, the core device is hardware-based.
Based on the provided information, the i-Polish device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cleaning and polishing procedures on teeth surface and fillings." This is a mechanical procedure performed directly on the patient's teeth.
- Device Description: The device is a "cordless prophylaxis handpiece" used with disposable prophylaxis angles. It's a tool for physical cleaning and polishing.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information for the diagnosis of a disease or condition.
- Anatomical Site: The device is used on "teeth surface and fillings," which are external anatomical sites, not internal samples.
- Predicate and Reference Devices: The predicate and reference devices are also described as "Cordless Handpiece System" and "Low-Speed Prophy Handpiece," which are consistent with dental tools for cleaning and polishing, not IVDs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The i-Polish device does not fit this description.
N/A
Intended Use / Indications for Use
i-Polish is a cordless prophylaxis handpiece equipped with control buttons and wireless foot control for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.
Product codes
EKX
Device Description
The Cordless Prophy system is a cordless handpiece which is intended for use by dental professionals for cleaning and polishing teeth. This is a general hygiene procedure that is performed on people of all ages in a professional dental operatory.
The Cordless Prophy System is comprised of a cordless, battery-powered handpiece, a removable and autoclavable outer sheath, an AC powered battery charging station, a battery-powered wireless foot control and an AC adapter. Accessories to the Cordless Prophy System include three style of Disposable Prophy Angle (DPA), which is cleared as Class I, Product code ESG, under premarket notification K030603.
Additionally, the handpiece of Cordless Prophy System must be used with a Disposable Sleeve, which is cleared as Class II, Product Code PEM, under premarket notification K151123.
The handpiece features a removable outer sheath that is to be cleaned and steam sterilized prior to first use and after each patient use.
The i-Polish has two speed control mode for operation:
- . Foot control mode: One is using it with the wireless foot control, where the amount of vertical actuation on the wireless foot control correlates to the speed of the handpieces supplied to the DPA, the corresponding variable speed range of the DPA is controlled and adjusted through varying pressure on the foot control. The adjustable range is 500 rpm to 4000 rpm;
- . Handpiece control mode: And the other uses a Centralized control button located on the handpieces for six constant speed level, 500 rpm, 1500 rpm, 1500 rpm, 2000 rpm,
3000 rpm and 4000 rpm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth surface and fillings
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
Dental professionals in a professional dental operatory.
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
Non-Clinical Test Summary:
- Electromagnetic Compatibility and Electrical Safety Test: The subject device passed safety testing according to IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, ISO 14457, ANSI/IEEE C63.27, FCC Rules and Regulations Part 15 Subpart C, and IEC 62133-2.
- Biocompatibility Test: The subject device passed safety testing according to ISO 10993-5 and ISO 10993-10.
- Software Validation: Software documentation consistent with moderate level of concern was submitted, and validation testing demonstrated that all software requirement specifications were met and all software hazards were mitigated to acceptable risk levels.
- Clinical Data: Substantial equivalence does not depend on clinical test data.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 17, 2021
Guilin Woodpecker Medical Instrument Co., Ltd. % Yoyo Chen Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian Avenue, Xili Town, Nanshan District Shenzhen, Guangdong 518100 China
Re: K211531
Trade/Device Name: Cordless Prophy System, Model: i-Polish Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: November 17, 2021 Received: November 29, 2021
Dear Yoyo Chen:
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
1
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 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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211531
Device Name Cordless Prophy System, Model: i-Polish
Indications for Use (Describe)
i-Polish is a cordless prophylaxis handpiece equipped with control buttons and wireless foot control for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.
| Type of Use (Select one or both, as applicable) | ☑ Remediation Under 21 CFR 1271 Subpart D☐ Use That Is Subject to 21 CFR 1271 Subpart C | ☑ Remediation Under 21 CFR 1271 Subpart D | ☑ Remediation Under 21 CFR 1271 Subpart D | ☐ Use That Is Subject to 21 CFR 1271 Subpart C | ☐ Use That Is Subject to 21 CFR 1271 Subpart C |
|---|---|---|---|---|---|
| ☑ Remediation Under 21 CFR 1271 Subpart D | ☑ Remediation Under 21 CFR 1271 Subpart D | ☐ Use That Is Subject to 21 CFR 1271 Subpart C | ☐ Use That Is Subject to 21 CFR 1271 Subpart C | ||
| ☑ Remediation Under 21 CFR 1271 Subpart D | |||||
| ☐ Use That Is Subject to 21 CFR 1271 Subpart C |
X Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This summary of 510(K) information is submitted As Required by requirements of SMDA and 21 CFR §807.92.
1. Administrative Information
| Submission Date | November 17, 2021 |
|---|---|
| Manufacturer | |
| information | Guilin Woodpecker Medical Instrument Co., Ltd. |
| Address: | |
| Information Industrial Park, Guilin National High-Tech Zone, | |
| Guilin, Guangxi, 541004, P.R. China | |
| Contact person: Ning Jiakang (宁加康) | |
| TEL: +86-773-2350532 | |
| FAX:+86-773-2350532 | |
| E-Mail: zmnbg03@glwoodpecker.com | |
| Submission | |
| Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| 1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian | |
| Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong | |
| Province, China. | |
| Contact person: Ms. Yoyo Chen | |
| E-Mail: yoyo@cefda.com; field@cefda.com | |
| Image: Logo | |
| Establishment | |
| registration number | 3005581016 |
2. Device Information
| Type of 510(k)
| Submission: | Traditional |
|---|---|
| 510 (k) number | K211531 |
| Device Name: | Cordless Prophy System |
| Model: | i-Polish |
| Classification Name: | Handpiece, Direct Drive, Ac-Powered |
| Review Panel: | Dental |
| Device Class: | 1 |
| Regulation Number: | 872.4200 |
| Product Code: | EKX |
4
3. Primary Predicate Device
| Manufacturer | Young Dental Manufacturing Co 1, LLC |
|---|---|
| Device name | Young INFINITY Cordless Handpiece System |
| 510(K) Number: | K171377 |
| Regulation Description | Dental handpiece and accessories |
| Product Code | EKX |
4. Reference Device
| Manufacturer | Parkell Products Inc. |
|---|---|
| Device name | Low-Speed Prophy Handpiece |
| 510(K) Number: | K983413 |
| Regulation Description | Dental handpiece and accessories |
| Product Code | EKX |
5. Device Description
The Cordless Prophy system is a cordless handpiece which is intended for use by dental professionals for cleaning and polishing teeth. This is a general hygiene procedure that is performed on people of all ages in a professional dental operatory.
The Cordless Prophy System is comprised of a cordless, battery-powered handpiece, a removable and autoclavable outer sheath, an AC powered battery charging station, a battery-powered wireless foot control and an AC adapter. Accessories to the Cordless Prophy System include three style of Disposable Prophy Angle (DPA), which is cleared as Class I, Product code ESG, under premarket notification K030603.
Additionally, the handpiece of Cordless Prophy System must be used with a Disposable Sleeve, which is cleared as Class II, Product Code PEM, under premarket notification K151123.
The handpiece features a removable outer sheath that is to be cleaned and steam sterilized prior to first use and after each patient use.
The i-Polish has two speed control mode for operation:
- . Foot control mode: One is using it with the wireless foot control, where the amount of vertical actuation on the wireless foot control correlates to the speed of the handpieces supplied to the DPA, the corresponding variable speed range of the DPA is controlled and adjusted through varying pressure on the foot control. The adjustable range is 500 rpm to 4000 rpm;
- . Handpiece control mode: And the other uses a Centralized control button located on the handpieces for six constant speed level, 500 rpm, 1500 rpm, 1500 rpm, 2000 rpm,
5
3000 rpm and 4000 rpm.
6. Intended use/Indication for use
i-Polish is a cordless prophylaxis handpiece equipped with control buttons and wireless foot control for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.
7. Comparison with Predicate Device
| Items | Subject Device
(K211531) | Predicate Device
(K171377) | Conclusion |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Product Code | EKX | EKX | Same |
| Class | 1 | 1 | Same |
| Regulation number | 872.4200 | 872.4200 | Same |
| Intended use/Indication
for use | i-Polish is a cordless prophylaxis
handpiece equipped with control
buttons and wireless foot control
for use with disposable
prophylaxis angles in hygiene
operatory to perform cleaning and
polishing procedures on teeth
surface and fillings. | Battery driven electrical drive
unit with wireless foot
controller for use with
disposable prophylaxis angles
in hygiene operatory to
perform cleaning and polishing
of tooth surfaces and fillings. | Same |
| Use | Rx Only | Rx Only | Same |
| Handpiece geometry | Cylindrical shape with reverse
radius geometry to aid in device
handling. Tapered, swiveled
nosecone area. | Cylindrical shape with reverse
radius geometry to aid in
device handling. Tapered,
swiveled nosecone area. | Same |
| Handpiece power | Lithium-ion Battery capable of
being recharged multiple
times by inclusion of an AC/DC
power supply. | Lithium-ion Battery capable of
being recharged multiple
times by inclusion of an
AC/DC power supply. | Same |
| Foot control power | Foot control contains a Lithium-
ion battery capable of being
recharged multiple times by
inclusion of
AC/DC power supply. | Foot control contains a
Lithium-ion battery capable of
being recharged multiple times
by inclusion of
AC/DC power supply. | Same |
| Charge time | Handpiece: Approximately 2.5
hours
Foot control: Approximately 2
hours | Handpiece: Approximately 2
hours
Foot control: Approximately 3
hours | Different
(Note 1) |
| Handpiece Dimension | 27.6mm Dia × 192mm | 25mm Dia × 156mm | Different
(Note 2) |
| Items | Subject Device (K211531) | Predicate Device (K171377) | Conclusion |
| Prophy Angle Fit | The device could be fit with
Disposable prophy angle which
cleared under premarket notification
K030603. | Similar to most corded
handpieces on the market
today, our device will have a
Doriot style nose which allows
most prophy angles to be
used on the device. | Different
(Note 3) |
| Nose Cone
(Also called as Outer
Sheath in the subject
device) | Outer sheath will swivel, the
Outer sheath will also be
removable and autoclavable for
infection control. | Nose cone will swivel. The
nosecone will also be
removable and autoclavable
for infection control. | Same |
| Infection
Control/Sterilization
Method | Outer sheath is to be to cleaned
and sterilized prior to first use and
after each patient. And the
handpiece is to be covered with
an FDA cleared Disposable
Sleeve which is cleared as Class
II, Product Code PEM, under
premarket notification K151123. | Remove nosecone and
sterilize via autoclave.
The nosecose is to be cleaned
and sterilized prior to first use
and after each patient.
Handpiece is to be covered
with an FDA cleared
Disposable Sleeve | Same |
| Lubrication Method | Lubricant Free Motor. Do not use
Lubrication | Lubricant Free Motor. Do not
use Lubrication | Same |
| User Interface on
Handpiece | That handpiece will have a
Centralized control button, which
will enable connection to the foot
control for activation. | That handpiece will have a
power button, which will enable
connection to the foot pedal for
activation. | Same |
| Auto-off | The foot control and handpiece will
automatically shut down if the
standby time exceeds 5 minutes.
The user would then have to press
the Centralized control button to
activate the handpiece again. | Handpiece will enter a standby
mode if idle for more than 4
minutes. The user would then
have to press the POWER
button to activate the
handpiece again. | Similar |
| Mode of Operation | Rotary | Rotary | Same |
| Speed Control | i-Polish has two speed control
mode for operation.
Handpiece control mode:
Speed is controlled and adjusted
through press the Centralized
control button to achieve six
constant speed level, 500 rpm,
1000 rpm, 1500 rpm, 2000 rpm,
3000 rpm and 4000 rpm. | Speed is controlled and
adjusted through varying
pressure on the foot pedal.
The motor itself has a limit of
3000RPM (±10%). | Different
(Note 4) |
| Items | Subject Device
(K211531) | Predicate Device
(K171377) | Conclusion |
| | Foot control mode:
Speed is controlled and adjusted
through varying pressure on the
foot control. The adjustable range
is 500 rpm to 4000 rpm. | | |
| Speed Range (±10%) | 500~4000 RPM | 500-3000 RPM | Different
(Note 4) |
| Maximum Torque
(±10%) | 1.2Ncm | 1Ncm | Similar |
| Operating environment | Ambient temperature: +5°C ~
+40°C
Relative humidity: 30% ~ 75%
Atmospheric pressure: 70kPa
~106kPa | Ambient temperature: +10°C ~
+35°C;
Relative humidity: 15% ~ 80% | Different
(Note 5) |
| Transport and Storage
Condition | Ambient temperature: -20°C ~
+55°C
Relative humidity: 10% ~ 93%
Atmospheric pressure: 70kPa
~106kPa | Ambient temperature: -20°C ~
+60°C;
Relative humidity: 8% ~ 80% | Different
(Note 5) |
| Compliance Standards | IEC 60601-1;
IEC 60601-1-2;
ISO 10993-5.
ISO 10993-10.
ISO 14457: | IEC 60601-1;
IEC 60601-1-2;
ISO 10993-5.
ISO 10993-10.
ISO 14457: | Same |
6
7
Note 1: Charge time
Although the charge time of the subject device is different with predicate device, but the battery is complied with the IEC62133-2:2017 standard, Otherwise, the subject device has been demonstrated to comply with the requirements of electrical safety IEC 60601-1:2015. This difference will not raise any new safety and effectiveness issues.
Note 2: Handpiece Dimension
The handpiece dimension has a little bit difference with predicate device, but both products allow for similar interaction with the user. Otherwise, the dimension of subject device has been demonstrated to comply with the requirements of ISO14457-2017standard. This difference will not raise any new safety and effectiveness issues.
Note 3: Prophy Angle Fit
The subject device only could be fit with Disposable prophy angle which cleared under premarket notification K030603. The prophy angle fit does not impact the user experience during cleaning and polishing procedures. This difference will not raise any new safety and effectiveness issues.
8
Note 4: Speed Control, Speed Range
Although the speed of subject device could be controlled and adjusted through press the Centralized control button and varying pressure on the foot pedal. But both devices deliver similar torque and speed profiles.
The low-end speed limit(500RPM) is the same. The top speed (4000RPM) is much higher than the predicate device, but the top speed is still lower than a reference device K983413 (the claimed top speed is able to operate up to 5000 RPM). In addition, a comparison test carried out between subject device and predicate device to demonstrate the difference on the top speed will not arise new safety and effectiveness issues.
Otherwise, the subject device has been demonstrated to comply with the requirements of IEC 60601-1, ISO 80601-2-60, and IEC60601-1-2 standard requirement. The difference will not raise any new safety and effectiveness issues.
Note 5: Operating environment and Transport and Storage Condition
The difference will not raise new safety or effectiveness issue, because, the subject device has tested to conform with the IEC 60601-1 standard.
8. Non-Clinical Test Summary
8.1. Electromagnetic Compatibility and Electrical Safety Test
The subject device has passed safety testing in according to following standards.
- IEC 60601-1:2005+AMD 1: 2012 Medical electrical equipment Part 1: General 1) requirements for basic safety and essential performance
-
- IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment Part 2-60: 3) Particular requirements for the basic safety and essential performance of dental equipment
-
- ISO 14457: 2017 Dentistry - Handpieces and motors
-
- ANSI/IEEE C63.27:2017 American National Standard for Evaluation of Wireless Coexistence
-
- FCC Rules and Regulations, Part 15, Subpart C
-
- The rechargeable lithium battery has passed the IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary lithium cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
8.2. Biocompatibility Test
The subject device has passed safety testing in according to following standards.
-
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro
9
cytotoxicity
-
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
9. Software Validation
Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrates that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels
10. Clinical Data
Substantial equivalence does not depend on the clinical test data.
11. Conclusion
The subject device is substantially equivalent to the primary predicate device (K171377). This conclusion is based upon comparison on indication for use, technological characteristics, and applicable safety standards. Any difference in the technological characteristics does not raise any new issues or concerns of safety or effectiveness.