(71 days)
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.
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.
Here's an analysis of the provided text regarding the DR Disposable Prophy Angle, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria for the DR Disposable Prophy Angle. Instead, it relies heavily on demonstrating substantial equivalence to a predicate device (Oral-B Disposable Prophy Angle W/Prophy Cup, K932990) by comparing various characteristics.
The "acceptance criteria" can be inferred as matching or being equivalent to the predicate device in the following categories:
| Acceptance Criteria Category (Inferred) | Reported Device Performance (DR Disposable Prophy Angle) | Predicate Device Performance (Oral-B Disposable Prophy Angle) | Notes |
|---|---|---|---|
| Usage | Single use by dental professionals to clean patient's teeth; disposed of after use on one patient. | Same | |
| Target Users | Professional Dentists and Hygienists. | Same | |
| Location of Use | Dental Offices. | Same | |
| Product Design | Plastic one-piece housing with 1 internal drive shaft and a spindle aligned at a right angle; tip fitted with rubber prophy cup. | Same | |
| Dimensions: Length | 49mm at insert | 49mm at insert | |
| Dimensions: Diameter | 12mm; 9mm at end | 12mm; 9mm at end | |
| Sterility | Non-Sterile | Non-Sterile | |
| Bio-compatibility | Prophy cups made of Non-Latex natural rubber. | Prophy cups made of natural rubber. | Minor difference: DR device uses "Non-Latex" natural rubber, which is usually considered an improvement for allergy concerns, not a deviation from equivalence. |
| Drive Mechanism | Rotation shafts driven by low speed dental hand piece. | Same | |
| Compatibility with Dental Handpiece | Designed to fit securely onto most ISO fitting standard slow speed dental hand pieces. | Same | |
| Performance | Sufficient for one cleaning cycle for one patient. | Same | |
| Mechanical Safety | Robust construction to withstand forces generated during cleaning cycle. | Same |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe an explicit test set or sample size for testing the DR Disposable Prophy Angle. The submission is a 510(k) Premarket Notification, which often relies on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive new clinical trials or performance studies for low-risk devices like this.
There is no mention of "country of origin of the data" or whether data was "retrospective or prospective" because an independent study with a test set, in the traditional sense, was not the primary basis of this submission. The comparison is based on the characteristics of the devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as there was no explicit "test set" and "ground truth" derived from expert consensus described in the submission for performance evaluation. The "ground truth" for the predicate device's characteristics would have been established during its own regulatory review, or by industry standards and common knowledge for such a device.
4. Adjudication Method for the Test Set
This information is not applicable as no test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this submission. This type of study is more common for diagnostic imaging AI devices, not for a mechanical dental instrument like a prophy angle.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a mechanical dental instrument and does not involve any algorithms or artificial intelligence.
7. The Type of Ground Truth Used
The "ground truth" implicitly used for this 510(k) submission is the established performance and safety characteristics of the predicate device, based on its prior market clearance (K932990) and general industry understanding of dental prophy angles. The argument is that the new device shares the "same intended use, performance and safety characteristics" as the predicate.
8. The Sample Size for the Training Set
This question is not applicable as the device does not involve algorithms or AI that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as #8.
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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. WestMaple 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 ProphyAngle with Prophy Cup510(K) 932990 | DR Disposable Prophy Angle |
|---|---|---|
| Usage | For single use by DentalProfessionals to cleanpatient's teeth. Device isdisposed of after use on onepatient. | Same |
| Target Users | Professional Dentists andHygienists | Same |
| Location of Use | Dental Offices | Same |
| Product Design | Plastic one-piece housing(external casing) with 1internal drive shaft and aspindle installed and alignedat right angle (90 degree)with each other. Tip ofspindle is fitted with therubber prophy cup forcleaning and polishing teeth. | Same |
| Dimensions:LengthDiameter | 49mmat insert12mm9mm at end | 49mmat insert12mm9mm at end |
| Sterility | Non-Sterile | Non-Sterile |
| Bio-compatibility | Prophy cups are made ofnatural rubber | Prophy cups are made ofNon-Latex natural rubber. |
| Drive Mechanism | Rotation shafts driven by lowspeed dental hand piece | Same |
| Compatibility with dental handpiece | Designed to fit securely ontomost ISO fitting standardslow speed dental handpieces. | Same |
| Performance | Sufficient for one cleaningcycle for one patient. | Same |
| Mechanical Safety | Robust construction towithstand forces generatedduring 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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)
§ 872.4200 Dental handpiece and accessories.
(a)
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.(b)
Classification. Class I.