Lotus Prophy Angle

K220346 · Ajk Engineering, Inc. · EGS · Nov 7, 2022 · Dental

Device Facts

• Record ID: K220346
• Device Name: Lotus Prophy Angle
• Applicant: Ajk Engineering, Inc.
• Product Code: EGS · Dental
• Decision Date: Nov 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The intended use of the Lotus Prophy Angle is for polishing and cleaning teeth.

Device Story

Lotus Prophy Angle is a single-use dental handpiece attachment used for polishing and cleaning tooth surfaces. The device consists of a housing, a pair of gears, a drive spindle, and a turning spindle equipped with a prophylaxis cup. It connects to a low-speed dental handpiece to transfer rotational motion to the cup. Used by dental professionals in clinical settings, the device facilitates mechanical cleaning and polishing of teeth. The device is provided in sealed packaging to prevent contamination.

Clinical Evidence

No clinical data. Bench testing performed in accordance with ANSI/ADA Specification No. 85-1, including speed, load, temperature rise, and vibration analysis.

Technological Characteristics

Materials: Polycarbonate (PC) housing/inserts, Polyoxymethylene (POM) gears, Silicone splatter guard, Thermoplastic Elastomer (TPE) cups. Mechanical transmission via gear-driven spindle. Single-use, non-sterile. Complies with ANSI/ADA Specification No. 85-1.

Indications for Use

Indicated for polishing and cleaning teeth in dental patients.

Regulatory Classification

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.

Predicate Devices

• ProAngle™ Disposable Prophy Angle (K030603)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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)

K220346

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.<br>1605 Ashley Court<br>Sommerville, SC 29486<br>Phone: [phone] |
|-------------------------|----------------------------------------------------------------------------------------------------------|
| Company Contact: | Ajay Kumar<br>[e-mail] |
| Official Correspondent: | Christine Scifert – MRC Global, LLC<br>[e-mail]<br>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)<br>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.

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# 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:<br>Pac-Dent International (Suzhou), Inc<br>ProAngle™ Disposable Prophy Angle |
|------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| 510(k) Number | SUBJECT | K030603 |
| Intended Use | Disposable Prophy Angle | Disposable Prophy Angle |
| Product Code | EGS | EGS |
| Indications for<br>Use | The intended use of the Lotus Prophy Angle is<br>for polishing and cleaning teeth. | The intended use of the ProAngle™ disposable<br>prophy angle is for polishing and cleaning<br>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.