DR DISPOSABLE PROPHY ANGLE MODEL H310

K060377 · Dental Resources · EGS · Apr 26, 2006 · Dental

Device Facts

• Record ID: K060377
• Device Name: DR DISPOSABLE PROPHY ANGLE MODEL H310
• Applicant: Dental Resources
• Product Code: EGS · Dental
• Decision Date: Apr 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

The DR Disposable Prophy Angle is a device intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The DR Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination.

Device Story

DR Disposable Prophy Angle; dental device for tooth polishing/cleaning. Consists of plastic housing, internal drive shaft, turning spindle, and prophylaxis cup. Connects to low-speed dental handpiece; handpiece provides rotational energy to drive spindle; spindle rotates prophy cup holding polishing paste. Used in dental offices by dentists/hygienists. Single-use design prevents cross-contamination. Benefits patient by providing hygienic, disposable tool for routine dental cleaning.

Clinical Evidence

Bench testing only. No clinical data provided. Device performance verified through comparison of design, dimensions, and mechanical construction to predicate.

Technological Characteristics

Plastic one-piece housing; internal drive shaft and spindle at 90-degree angle; non-latex natural rubber prophy cup. Dimensions: 49mm length, 12mm insert diameter, 9mm end diameter. Mechanical drive via low-speed dental handpiece. Non-sterile.

Indications for Use

Indicated for professional dentists and dental hygienists to polish and clean tooth surfaces. Single-use device.

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

• Oral-B Disposable Prophy Angle W/Prophy Cup (K932990)

Submission Summary (Full Text)

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K060377

Tab 5

APR 2 6 2006

# Premarket Notification [510(k)] Summary

| Date Prepared: | February 8, 2006 |
|----------------------|------------------------------------------------------|
| Trade Name: | DR Disposable Prophy Angle |
| Common Name: | Disposable Prophy Angle |
| Classification Name: | Handpiece, Contra-and Right-Angle Attachment, Dental |
| Company Name: | Dental Resources |
| Address: | 400 Congress St. West<br>Maple Lake, MN 55358 |
| Contact: | Bryan Nichols |
| Title: | Vice President of Operations |
| Telephone: | 320.963.6267 |
| Fax: | 320.963.2029 |

Predicate Device: Oral-B Disposable Prophy Angle W/Prophy Cup, K932990.

Device Description: The DR Disposable Prophy Angle is a dental device that consists of a pair of gears, a turning spindle and a drive spindle enclosed in a plastic housing, that connects to a low speed dental handpiece. The turning spindle has a prophylaxis cup attached to the end which holds dental tooth polishing paste.

Intended Use: Professional dentists and dental hygienists use this type of device for polishing and cleaning the surface of teeth. The DR Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination.

The DR Prophy Angle has the same intended use, performance and safety characteristics as the predicate device; see the following comparative table.

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# Technological Characteristics: Predicate Device Comparison Table

| Device | Oral-B Disposable Prophy<br>Angle with Prophy Cup<br>510(K) 932990 | DR Disposable Prophy Angle |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Usage | For single use by Dental<br>Professionals to clean<br>patient's teeth. Device is<br>disposed of after use on one<br>patient. | Same |
| Target Users | Professional Dentists and<br>Hygienists | Same |
| Location of Use | Dental Offices | Same |
| Product Design | Plastic one-piece housing<br>(external casing) with 1<br>internal drive shaft and a<br>spindle installed and aligned<br>at right angle (90 degree)<br>with each other. Tip of<br>spindle is fitted with the<br>rubber prophy cup for<br>cleaning and polishing teeth. | Same |
| Dimensions:<br>Length<br>Diameter | 49mm<br>at insert<br>12mm<br>9mm at end | 49mm<br>at insert<br>12mm<br>9mm at end |
| Sterility | Non-Sterile | Non-Sterile |
| Bio-compatibility | Prophy cups are made of<br>natural rubber | Prophy cups are made of<br>Non-Latex natural rubber. |
| Drive Mechanism | Rotation shafts driven by low<br>speed dental hand piece | Same |
| Compatibility with dental hand<br>piece | Designed to fit securely onto<br>most ISO fitting standard<br>slow speed dental hand<br>pieces. | Same |
| Performance | Sufficient for one cleaning<br>cycle for one patient. | Same |
| Mechanical Safety | Robust construction to<br>withstand forces generated<br>during cleaning cycle. | Same |

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal or logo. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or other bird with its wings spread. The image is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bryan Nichols Vice President Operations Dental Resources 400 Congress Street West Maple Lake, Minnesota 55358

APR 2 6 2006

Re: K060377

Trade/Device Name: DR Disposable Prophy Angle Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: February 10, 2006 Received: February 15, 2006

Dear Mr. Nichols:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Nichols

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, prease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

Sylvie Y. McMahon Omd

Chiu Lin, Ph.D. 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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## Tab 4

## Statement of Indications For Use

510(k) Number (if known): _ 5060377

Device Name: DR Disposable Prophy Angle

### Indications for Use:

The DR Disposable Prophy Angle is a device intended to be attached to a low speed dental handpiece and used by professional dentists and dental hygienists for polishing and cleaning the surface of teeth. The DR Disposable Prophy Angle is intended for single use, thus eliminating the possibility of cross contamination.

Susan Russer

" Joney, General Hospital. al Levices

Y060377

Prescription Use V (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)