(273 days)
No
The device description and performance studies focus on mechanical components and physical testing, with no mention of AI or ML.
No
The device is described for polishing and cleaning teeth, which are preventive and maintenance procedures, not therapeutic (treating a disease or condition).
No
The device is described as being used for "polishing and cleaning teeth," which are treatment/maintenance functions, not diagnostic ones. Its intended use explicitly states "for polishing and cleaning teeth," and the device description also reiterates this function. There is no mention of it detecting, identifying, or assessing any medical condition or characteristic.
No
The device description clearly outlines physical components like gears, spindles, and a prophylaxis cup, indicating it is a hardware device, not software-only.
Based on the provided information, the Lotus Prophy Angle is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for polishing and cleaning teeth." This is a mechanical action performed directly on the patient's teeth, not an in vitro test performed on a sample taken from the body.
- Device Description: The description details a mechanical device with gears and a cup for polishing. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on biological material.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Lotus Prophy Angle's function is purely mechanical and therapeutic (cleaning and polishing).
N/A
Intended Use / Indications for Use
The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.
Product codes
EGS
Device Description
Lotus Prophy Angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.
Lotus Prophy Angle is intended for single use only and is provided aseptic in sealed packaging to be prevent contamination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The subject Lotus Prophy Angle is identical in every way to the previously cleared ProAngle™ Disposable Prophy Angle (K030603). Therefore, all previous testing performed on the ProAngle™ Disposable Prophy Angle is applicable to the subject device. The following confirmatory testing was performed on the subject device in accordance with ANSI/ADA Specification No. 85-1 - Disposable Prophy Angles: Speed, Load, Temperature Rise, and Vibration Analysis.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
November 7, 2022
AJK Engineering, Inc. % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Circle, Suite 110 Centennial, Colorado 80112
Re: K220346
Trade/Device Name: Lotus Prophy Angle Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: August 12, 2022 Received: August16, 2022
Dear Christine Scifert:
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
1
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 (OS) 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,
Bobak Shirmohammadi -S
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
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Indications for Use
510(k) Number (if known)
Device Name Lotus Prophy Angle
Indications for Use (Describe)
The intended use of the Lotus Prophy Angle 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)
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510(k) Summary Lotus Prophy Angle August 12, 2022
| Company: | AJK Engineering, Inc.
1605 Ashley Court
Sommerville, SC 29486
Phone: 888-962-1652 |
|-------------------------|----------------------------------------------------------------------------------------------------------|
| Company Contact: | Ajay Kumar
ajay@lotus-dpa.com |
| Official Correspondent: | Christine Scifert – MRC Global, LLC
Christine.scifert@askmrcglobal.com
901-831-8053 |
| Trade Name: | Lotus Prophy Angle |
| Common Name: | Handpiece, Contra- And Right-Angle Attachment, Dental |
| Classification: | Class I |
| Regulation Number: | 21 CFR 872.4200 |
| Panel: | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices |
| Product Code: | EGS |
Device Description:
Lotus Prophy Angle is a device used for polishing and cleaning the surface of teeth. It consists of a pair of gears, a turning spindle and a drive spindle which can connect the low speed handpiece. The turning spindle has a prophylaxis cup on it for polishing or cleaning teeth.
Lotus Prophy Angle is intended for single use only and is provided aseptic in sealed packaging to be prevent contamination.
Indications for Use:
The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.
4
Substantial Equivalence:
The subject device is substantially equivalent to the following predicate device:
Primary Predicate:
Pac-Dent International (Suzhou), Inc., ProAngle™ Disposable Prophy Angle, K030603
| Characteristic | Lotus Prophy Angle | Primary Predicate:
Pac-Dent International (Suzhou), Inc
ProAngle™ Disposable Prophy Angle |
|------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 510(k) Number | SUBJECT | K030603 |
| Intended Use | Disposable Prophy Angle | Disposable Prophy Angle |
| Product Code | EGS | EGS |
| Indications for
Use | The intended use of the Lotus Prophy Angle is
for polishing and cleaning teeth. | The intended use of the ProAngle™ disposable
prophy angle is for polishing and cleaning
teeth. |
| Materials | Housing: Polycarbonate (PC) | Housing: Polycarbonate (PC) |
| | Gears: Polyoxymethylene (POM) | Gears: Polyoxymethylene (POM) |
| | Splatter guard: Silicone | Splatter guard: Silicone |
| | Cups: Thermoplastic Elastomer (TPE) | Cups: Thermoplastic Elastomer (TPE) |
| | Inserts: Polycarbonate (PC) | Inserts: Polycarbonate (PC) |
| Sterility | Non-Sterile | Non-Sterile |
The subject and predicate devices are identical in Intended Use, Technological Characteristics, Performance Specifications, and Material. Therefore, it can be concluded that the subject Lotus Prophy Angle does not raise new questions of safety and effectiveness when compared to the predicate devices.
Performance Testing:
The subject Lotus Prophy Angle is identical in every way to the previously cleared ProAngle™ Disposable Prophy Angle (K030603). Therefore, all previous testing performed on the ProAngle™ Disposable Prophy Angle is applicable to the subject device. The following confirmatory testing was performed on the subject device in accordance with ANSI/ADA Specification No. 85-1 - Disposable Prophy Angles: Speed, Load, Temperature Rise, and Vibration Analysis.
Conclusion:
Since the subject and predicate device are identical in every way, the subject device is determined to be substantially equivalent to the predicate device.