PRO-FLEX DISPOSABLE PROPHY ANGLE

K981869 · Professional Dental Mfg., Inc. · EFB · Aug 11, 1998 · Dental

Device Facts

• Record ID: K981869
• Device Name: PRO-FLEX DISPOSABLE PROPHY ANGLE
• Applicant: Professional Dental Mfg., Inc.
• Product Code: EFB · Dental
• Decision Date: Aug 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Professional Dental Manufacturing, Inc.'s Pro-Flex™ Disposable Prophy Angle is intended for one time use by dental professionals during general prophylaxis. Pro-Flex™ is used to clean and polish teeth by application of a prophy angle with a rotating rubber cup, combined with a cleaning and polishing paste or powder, to the surfaces of teeth.

Device Story

Disposable dental prophylaxis angle; consists of plastic body with integrated drive mechanism and rubber cup. Connects to dental handpiece; handpiece provides power to rotate rubber cup. Used by dental professionals in clinical settings for tooth cleaning and polishing procedures using abrasive paste or powder. Device is single-use to facilitate hygiene and prevent cross-contamination.

Clinical Evidence

No clinical data. Safety assessment based on review of Medical Device Records (MDR) from 1992-1996 for similar disposable prophy angles, identifying no serious injury events.

Technological Characteristics

Disposable plastic body; rubber cup; mechanical drive shaft; connects to standard dental handpiece. No electronic components or software.

Indications for Use

Indicated for use by dental professionals for one-time, professionally administered prophylaxis treatment to clean and polish teeth.

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

• NUPRO® Disposable Prophy Angle (Dentsply)

Submission Summary (Full Text)

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Ka81869

#### SUMMARY OF SAFETY AND EFFECTIVENESS -

#### 1. Name and Address

This Summary of Safety and Effectiveness is being submitted by Professional Dental Manufacturing, Inc., 633 Lawrence Street, Batesville, Arkansas 72501. The telephone number is 870-698-2300.

### 2. Name of the Device

The device is generally known as a dental prophylaxis angle.

### 3. Identification of Predicate Device(s)

Dentsply's NUPRO® Disposable Prophy Angle.

### 4. Description of the Device

The device is a disposable dental prophylaxis angle which consists of a plastic body integrally formed with a drive mechanism, and a rubber cup that attaches to a retention knob or stud on the angle. The prophy angle has a slot for connecting the angle to a dental handpiece, which powers the prophy angle. The drive shaft of the prophy angle allows the rubber prophy cup to rotate.

### 5. Intended Use of the Device

Professional Dental Manufacturing, Inc.'s Pro-Flex™ Disposable Prophy Angle is intended for one time use by dental professionals during general prophylaxis. Pro-Flex™ is used to clean and polish teeth by application of a prophy angle with a rotating rubber cup, combined with a cleaning and polishing paste or powder, to the surfaces of teeth.

## 6. Comparison of Technological Characteristics

The differences in design between the Pro-Flex™ and the predicate device are very minor and do not impact the safety and effectiveness of the device in any significant way since the function and intended use are the same.

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# 7. Safety

Professional Dental Manufacturing, Inc. reviewed the Medical Device Records (MDR) filed with CDRH during the period from 1992 through 1996 for information on prophy angles which may have caused a death or serious injury. Of the more than 200 MDRs filed, no serious injury events were reported. A single MDR indicated that a disposable prophy angle purportedly caused grooves or wearing away of enamel on the facial aspects of several teeth.

The other events reported were malfunctions falling into one of the following categories: the prophy angle stalled or locked up, the drive gears came apart, or the angle got hot. Several events reported that the rubber cup came off the prophy angle, occasionally in the patient's mouth, but no injuries were reported due to this or the other described malfunctions.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of a bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | | | 1998

Bob Zahradnik, Ph.D. Professional Dental Manufacturing, Inc. 633 Lawrence Street Batesville, Arizona 72501

Re : K981869 Pro-Flex™ Disposable Prophy Angle Trade Name: Requlatory Class: I Product Code: EFB Dated: May 28, 1998 Received: May 28, 1998

Dear Dr. Zahradnik:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Dr. Zahradnik

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Dutram fr

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure .... ..............

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Page 1 of 1

| 510(k) Number (if known): | |
|---------------------------|-------------------------------------------------------------------------------------------------------------|
| Device Name: | Pro-Flex™ Disposable Prophy Angle |
| Indications For Use: | For one time use as part of a professionally administered prophylaxis treatment, to clean and polish teeth. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | <div><img alt="signature" src="signature.png"/></div> <div>(Division Sign-Off)</div> <div>Division of Dental, Infection Control,</div> <div>and General Hospital Devices</div> |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K981869 |

| Prescription Use <img alt="checkmark" src="checkmark.png"/> | OR | Over-the-Counter Use ______ |
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