MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM

K110753 · Dentsply International, Inc. · EKX · Jun 6, 2011 · Dental

Device Facts

• Record ID: K110753
• Device Name: MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM
• Applicant: Dentsply International, Inc.
• Product Code: EKX · Dental
• Decision Date: Jun 6, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The MIDWEST® RDH Freedom™ Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Freedom disposable prophylaxis angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.

Device Story

Cordless, electric motor-driven handpiece; used with disposable prophylaxis angles (soft cup, hard cup, or brush). Operates via wireless foot pedal; vertical pedal displacement controls handpiece speed. Internal motion sensor activates device when picked up. No direct operator controls on handpiece. Used in dental hygiene operatory by dental professionals. Autoclavable aluminum outer sheath for infection control. Battery-powered; rechargeable via AC base. Benefits include cordless mobility, reduced noise compared to traditional air-powered handpieces, and improved ergonomics for cleaning/polishing procedures.

Clinical Evidence

No clinical data. Safety and efficacy verified through non-clinical bench testing, including design verification, speed/torque control, battery life, noise testing, software validation, sterilizability, biocompatibility, and electrical safety.

Technological Characteristics

Cordless electric motor handpiece; aluminum autoclavable outer sheath; plastic/rubber disposable prophy angles. Powered by rechargeable Li-ion battery in foot pedal. Wireless communication between pedal and handpiece. Internal motion sensor for activation. Speed/torque ranges comparable to traditional air-driven handpieces.

Indications for Use

Indicated for use by dental professionals on patients of all ages in a professional dental operatory to perform tooth cleaning and polishing procedures using prophy pastes or polishes.

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

• Zen Cordless Prophy System (K101612)

Submission Summary (Full Text)

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# K110753

JUN - 6 2011

### DENTSPLY International

World Headquarters Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405-0872 18001 877-0020 Fax [phone] www.dentsply.com

### SECTION 5

### 510(k) SUMMARY for MIDWEST® RDH Freedom™ Cordless Prophy System

#### 1.0 Submitter Information

DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

| Contact Person: | Helen Lewis |
|-------------------|--------------|
| Telephone Number: | 717-849-4229 |
| Fax Number: | 717-849-4343 |

Date Prepared: 17 March 2011

#### 2.0 Device Name

Proprietary Name: Common Name: Classification Name: CFR Number: Device Class: Product Code:

MIDWEST® RDH Freedom™ Cordless Prophy System Prophy System Handpiece, Direct Drive, AC Powered 872.4200 I EKX

#### 3.0 Predicate Device

Zen Cordless Prophy System by Discus Dental, product code EKX, K101612. Indications for Use - The Zen Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Zen's disposable prophylaxis angles to clean and polish teeth.

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#### 4.0 Description of Device

The MIDWEST® RDH Freedom™ Cordless Prophy System is comprised of a cordless, electric motor-driven handpiece, an AC powered battery charging base and a wireless foot pedal. The handpiece utilizes Freedom disposable prophylaxis angles (single use) that are available with soft cup, hard cup or brush features. The handpiece has been designed for comfort and control Sont vap, had bap or oriece has no direct operator controls, and has an internal motion sensing by the ason." The mailpropare for operation when the handpiece is picked up. The handpiece can only be operated by the cordless foot pedal, and the amount of vertical displacement on the foot pedal corresponds to the speed of the handpiece. The handpiece is quieter than traditional hygiene and low speed handpieces and features an autoclavable outer sheath for infection hygiene and low speed inancipies and m Cordless Prophy System handpiece battery has control. The MID w BOY's worth of procedures on a single charge, and the system is sumerent power to completing one cleaning procedure after only fifteen minutes of charging. capable or completing one typlem sidning charger base and the foot pedal are all housed in various plastics. The autoclavable outer sheath is made from aluminum, and the single use disposable prophy angles are made from plastic (and rubber cups).

#### Indications for Use 5.0

The MIDWEST® RDH Freedom™ Cordless Prophy System is a high-performance cordless The With a wireless foot pedal for use with Freedom disposable prophylaxis angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.

The device is a cordless version of a traditional corded, air powered, low speed handpiece that is r he device is a cordical velsion cleaning and polishing teeth. This system is used in conjunction with prophy pastes or polishes when the procedure is being performed. This is a general hygiene with propis painter of performed on people of all ages in a professional dental operatory.

The indications for use of the MIDWEST® RDH Freedom™ Cordless Prophy System and the The murchions Prophy System are essentially the same. They are both cordless, low speed handpieces that are used by a dental professional for cleaning and polishing teeth.

### Identification of Risk Analysis Method 6.0

Risk analysis was performed on the MIDWEST® RDH Freedom™ Cordless Prophy System Risk analysis was performed on the MD . Le 207. The results of the risk analysis performed unitizang an FMEA process based on ISO 11971 12001 System concluded that all device design on the MIDWEST® RDTI Recom - Ocreases Proper potential failures and effects. In controls and piocess confors will be able to mangers and electrical safety and electromagnetic addition; performain were performed to mitigate other potential risks.

PERSONAL

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#### Description of Safety and Substantial Equivalence 7.0

#### Technological Characteristics . 7.1

The technological characteristics of the MIDWEST® RDH Freedom™ Cordless Prophy System are very similar to the Zen Cordless Prophy System in that they are both cordless devices used for prophylaxis cleaning and powered by a cordless foot pedal. The foot pedal in the MIDWEST® RDH Freedom™ Cordless Prophy System has a Lithium-Ion battery and is able to be recharged multiple times by inclusion of an AC/DC power supply. The foot pedal in the Zen Cordless Prophy System does not have an power supply and takes 1.5V AAA batteries which does not allow for the foot pedal battery to be recharged internally. The MIDWEST® RDH Freedom™ Cordless Prophy System and the Zen Cordless Prophy System both have proprietary Disposable Prophy Angles that work exclusively with their own systems. Both systems include removable, autoclavable outer sheaths for infection control. The Zen Prophy System has a handpiece with two options for operation; one is using it with the wireless foot pedal and the other uses a power button located on the handpiece for a constant speed mode. The MIDWEST® RDH Freedom™ Cordless Prophy System has a handpiece that does not have any user interface, and the handpiece is controlled exclusively by the cordless foot pedal. The MIDWEST® RDH Freedom™ Cordless Prophy System and the Zen Prophy System have similar speeds and similar torques, which are well within the range of traditional air-driven hygiene handpieces.

#### Non-Clinical Performance Data 7.2

Performance testing focused on verification of design, speed, torque, function and safety of the MIDWEST® RDH Freedom™ Cordless Prophy System. The testing included verification of component specifications, speed and torque control, battery life, noise testing, software validation, sterilizability, biocompatibility and electrical equipment safety. Tests were also performed to compare the speed and torque ranges of the MIDWEST® RDH Freedom™ Cordless Prophy System to the Zen Cordless Prophy System to verify substantial equivalence. The results of these performance tests Bystem to that the MIDWEST® RDH Freedom™ Cordless Prophy System is safe and effective for its intended use as a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Freedom disposable prophylaxis angles in a hygiene operatory to perform cleaning and polishing procedures on teeth. This testing also operatory to perioding and Freedom™ Cordless Prophy System is substantially verifications the MD MD Cordless Prophy System in design, component specifications, equivalent to the 201 Control, battery life, sterilizability, biocompatibility and electrical equipment safety.

DENTSPLY International

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#### Clinical Performance Data 7.3

K110753

Due to the low risk nature of the MIDWEST® RDH Freedom™ Cordless Prophy System, clinical performance data was not applicable for verification of safety and efficacy.

#### Conclusion as to Substantial Equivalence 7.4

The similarities in design, function, safety and intended use of the MIDWEST® RDH Freedom™ Cordless Prophy System with the legally marketed device, the Zen Cordless Prophy System, provide evidence that these devices are substantially equivalent. The I ropiny System, provide our support the safety and effectiveness of the MIDWEST® RDH Freedom™ Cordless Prophy System for its indicated use.

MIDWEST® RDH Freedom™ Cordless Prophy System

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Helen Lewis Director Corporate Compliance and Regulatory Affairs Dentsply International, Incorporated 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17404

JUN - 6 2011

Re: K110753

Trade/Device Name: MIDWEST RDH Freedom Cordless System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: May 25, 2011 Received: May 26, 2011

Dear Ms. Lewis:

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. 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.

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Page 2- Ms. Lewis

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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

h for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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### Section 4. INDICATIONS FOR USE STATEMENT

KU0753 510(k) Number (if known):

Device Name: MIDWEST® RDH Freedom™ Cordless Prophy System

Indications for Use:

1.

The MIDWEST® RDH Freedom™ Cordless Prophy System is a high-performance cordless prophylaxis handpiece with a wireless foot pedal for use with Freedom disposable prophylaxis angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.

Prescription Use ___X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suor Ruann

(División Sign-Off) (Division Sign-Chi)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K110753

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