(415 days)
The intended use of DPA is for polishing and cleaning teeth.
Plastic one-piece housing (external casing) with 1 internal drive shaft and a spindle installed and aligned at right angle (90 degree) with each other. The tip of spindle is fitted with rubber prophy cup for cleaning and polishing teeth. A small amount of food-grade grease is added between the drive shaft and the spindle as lubrication. The disposable prophylaxis angle is available in a soft cup and firm cup format, which differ in the material used to form the cup. The Medicom and Practicon brands differ in logo and packaging, but utilize the same design.
This FDA 510(k) clearance letter pertains to a Disposable Prophy Angle, a dental device, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, training set details) is not applicable to this document.
However, I can extract the relevant information regarding performance criteria and testing for this device.
Acceptance Criteria and Study for Disposable Prophy Angle (K240950)
This document describes the 510(k) clearance for a Disposable Prophy Angle, a dental handpiece accessory used for polishing and cleaning teeth. The device is not an AI/ML medical device, and thus, many of the typical AI/ML study parameters are not applicable.
The submission demonstrates substantial equivalence to predicate devices by meeting recognized performance requirements through non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
The documentation references compliance with a specific industry standard for performance.
| Acceptance Criterion (Standard Ref.) | Device Performance |
|---|---|
| Conformance to ANSI ADA Spec. No. 85, Part I: Disposable Prophy Angles, section 5.5 | The device "conforms to the performance requirements (nonclinical tests) as specified in ANSI ADA Specification No. 85, Part I: Disposable Prophy Angles, section 5.5." This implies that all criteria within this section of the standard were met. |
| Temperature Rise (relative to predicate) | "Temperature rise...testing were performed on all models of the device (soft cup and firm cup) to demonstrate equivalent performance to the predicate device." (It passed, indicating equivalent or better performance against the predicate concerning temperature rise). |
| Vibration (relative to predicate) | "Vibration testing were performed on all models of the device (soft cup and firm cup) to demonstrate equivalent performance to the predicate device." (It passed, indicating equivalent or better performance against the predicate concerning vibration). |
Note: The specific numerical values or thresholds for "temperature rise" and "vibration" are not provided in this summary but would be detailed in the full test reports submitted to the FDA.
2. Sample size used for the test set and the data provenance
Not Applicable (N/A). This is a hardware dental device. The testing described is non-clinical performance testing (temperature rise, vibration) based on engineering specification compliance, not an AI/ML model evaluated on a test set of data. The "test set" would refer to the physical samples of the device and its components. The document doesn't specify the number of units tested, only that "all models of the device (soft cup and firm cup)" were tested.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable (N/A). Ground truth based on expert review is specific to AI/ML or diagnostic image analysis. For this device, "ground truth" refers to established engineering standards (ANSI ADA Specification No. 85) and comparative performance against a predicate device.
4. Adjudication method for the test set
Not Applicable (N/A). Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers in AI/ML or diagnostic studies. This is a non-clinical, hardware performance test.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not Applicable (N/A). This is not an AI/ML device; therefore, an MRMC study and analysis of human reader improvement with AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable (N/A). This is not an algorithm or software device.
7. The type of ground truth used
The "ground truth" (or basis for acceptance) for this device's performance testing is:
- Established engineering standards: Specifically, "ANSI ADA Specification No. 85, Part I: Disposable Prophy Angles, section 5.5."
- Comparative equivalence: Demonstration of "equivalent performance to the predicate device" for temperature rise and vibration.
8. The sample size for the training set
Not Applicable (N/A). This is a hardware device; there is no training set for an AI/ML model.
9. How the ground truth for the training set was established
Not Applicable (N/A). There is no training set for an AI/ML model.
FDA 510(k) Clearance Letter - K240950
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 28, 2025
Pacific Care Limited
Chris Kwong
Director
Unit 308-309, 15W, Hong Kong Science Park
N.T.,
HONG KONG
Re: K240950
Trade/Device Name: Disposable Prophy Angle
Regulation Number: 21 CFR 872.4200
Regulation Name: Dental Handpiece And Accessories
Regulatory Class: Class I, reserved
Product Code: EGS
Dated: September 19, 2024
Received: September 19, 2024
Dear Chris Kwong:
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.
Page 2
K240950 - Chris Kwong Page 2
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 (QS) 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 (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-reporting-combination-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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K240950 - Chris Kwong Page 3
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 E. 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K240950
Device Name
Disposable Prophy Angle;
Medicom(R) DentiCare Spin (TM) Disposable Prophy Angle;
Practicon(R) Contours (TM) Disposable Prophy Angle
Indications for Use (Describe)
The intended use of DPA is for polishing and cleaning teeth.
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)
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."
Page 5
510(k) Summary
510(k)#: K240950
Prepared on: 2025-05-21
Contact Details
21 CFR 807.92(a)(1)
| Field | Information |
|---|---|
| Applicant Name | Pacific Care Limited |
| Applicant Address | Unit 308-309, 15W, Hong Kong Science Park N.T. Hong Kong |
| Applicant Contact Telephone | +852 3568 6838 |
| Applicant Contact | Ms. Chris Kwong |
| Applicant Contact Email | jonathan@pac-care.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Information |
|---|---|
| Device Trade Name | Disposable Prophy Angle; Medicom(R) DentiCare Spin (TM) Disposable Prophy Angle; Practicon(R) Contours (TM) Disposable Prophy Angle |
| Common Name | Dental handpiece and accessories |
| Classification Name | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Regulation Number | 872.4200 |
| Product Code(s) | EGS |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K220346 | Lotus Prophy Angle | EGS |
| K790722 | Prophylaxis Angle | EGS |
Device Description Summary
21 CFR 807.92(a)(4)
Plastic one-piece housing (external casing) with 1 internal drive shaft and a spindle installed and aligned at right angle (90 degree) with each other. The tip of spindle is fitted with rubber prophy cup for cleaning and polishing teeth. A small amount of food-grade grease is added between the drive shaft and the spindle as lubrication. The disposable prophylaxis angle is available in a soft cup and firm cup format, which differ in the material used to form the cup. The Medicom and Practicon brands differ in logo and packaging, but utilize the same design.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The intended use of DPA is for polishing and cleaning teeth.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use are the same as the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
Page 6
The device has the same design, principle of operation and energy source as the predicate device. The material used for the cup (which is the core component in contact with the patient) is also the same as the predicate device. All the materials have been tested as safe in the biocompatibility testing, and have comparable passed results in the performance testing as compared to the predicate device. Therefore, it can be concluded that the subject does not raise new questions of safety and effectiveness when compared to the predicate devices.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
The device has been reviewed and complied to the Guidance for Industry and FDA Staff, Dental Handpieces - Premarket Notification [510(k)] Submissions. In addition, it conforms to the performance requirements (nonclinical tests) as specified in ANSI ADA Specification No. 85, Part I: Disposable Prophy Angles, section 5.5. This specification is the most relevant FDA recognized consensus standard for this type of device. Temperature rise and vibration testing were performed on all models of the device (soft cup and firm cup) to demonstrate equivalent performance to the predicate device.
§ 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.