Medidenta High Speed Handpieces

K202674 · Pac-Dent, Inc. · EFB · Dec 12, 2022 · Dental

Device Facts

• Record ID: K202674
• Device Name: Medidenta High Speed Handpieces
• Applicant: Pac-Dent, Inc.
• Product Code: EFB · Dental
• Decision Date: Dec 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Medidenta High Speed Handpieces are intended for removing carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are by a trained professional in the field of general dentistry.

Device Story

Medidenta High Speed Handpieces are dental instruments used by trained professionals in general dentistry. The device functions as a mechanical tool for removing carious material, preparing cavities and crowns, removing fillings, and processing tooth and restoration surfaces. It is a manual, air-driven or electric-driven handpiece operated by the clinician to perform restorative dental procedures. The device provides the mechanical action necessary for cutting and finishing dental tissues and materials. It does not involve automated processing, software, or electronic data analysis.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Mechanical dental handpiece; air or electric-driven; handheld form factor; intended for use in general dentistry; non-software device.

Indications for Use

Indicated for use by trained general dentistry professionals for removal of carious material, cavity and crown preparation, removal of fillings, and processing of tooth and restoration surfaces.

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.

Submission Summary (Full Text)

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December 12, 2022

Pac-Dent, Inc. Jingtian Peng R&d 670 Endeavor Circle Brea, California 92821

Re: K202674

Trade/Device Name: Medidenta High Speed Handpieces Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: November15, 2022 Received: November15, 2022

Dear Jingtian Peng:

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 -2

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) K202674

Device Name Medidenta High Speed Handpieces

Indications for Use (Describe)

Medidenta High Speed Handpieces are intended for removing carious material, cavities and crown preparations, removal of fillings, and processing of tooth and restoration surfaces. They are by a trained professional in the field of general dentistry.

| Type of Use (Select one or both, as applicable) | <div> <input type="checkbox"/> <input type="checkbox"/> </div> |
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X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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