(71 days)
Not Found
No
The summary describes a mechanical dental device for polishing teeth and makes no mention of AI or ML.
No
The device is used for polishing and cleaning teeth, which are preventive and maintenance procedures, not therapeutic ones addressing a disease or condition.
No
The device is described as being used for polishing and cleaning the surface of teeth, not for diagnosing any conditions.
No
The device description clearly outlines physical components like gears, spindles, and a plastic housing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "polishing and cleaning the surface of teeth." This is a mechanical action performed directly on the patient's teeth.
- Device Description: The device description details mechanical components (gears, spindles, housing, prophy cup) used for polishing.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide diagnostic information about a patient's health condition. IVDs are used to diagnose diseases or other conditions, or in the cure, mitigation, treatment, or prevention of disease.
This device is a dental instrument used for a therapeutic/prophylactic procedure (cleaning and polishing), not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
EGS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional dentists and dental hygienists/Dental Offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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 |
| 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.
1
Technological Characteristics: Predicate Device Comparison Table
| Device | Oral-B Disposable Prophy
Angle with Prophy Cup
510(K) 932990 | DR Disposable Prophy Angle |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|
| Usage | For single use by Dental
Professionals to clean
patient's teeth. Device is
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
(external casing) with 1
internal drive shaft and a
spindle installed and aligned
at right angle (90 degree)
with each other. Tip of
spindle is fitted with the
rubber prophy cup for
cleaning and polishing teeth. | Same |
| Dimensions:
Length
Diameter | 49mm
at insert
12mm
9mm at end | 49mm
at insert
12mm
9mm at end |
| Sterility | Non-Sterile | Non-Sterile |
| Bio-compatibility | Prophy cups are made of
natural rubber | Prophy cups are made of
Non-Latex natural rubber. |
| Drive Mechanism | Rotation shafts driven by low
speed dental hand piece | Same |
| Compatibility with dental hand
piece | 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
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.
3
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
4
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)