(79 days)
790722
Not Found
No
The device description and intended use clearly describe a simple mechanical disposable prophy angle, with no mention of any computational or analytical capabilities that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
No
The device is used to assist in the cleaning process of teeth during a professional prophylaxis treatment, which is a preventive measure rather than a therapeutic one. It does not treat a disease or condition.
No
The device is described as a disposable attachment for cleaning and polishing teeth during prophylaxis treatment, not for diagnosing medical conditions. Its function is to assist in the cleaning process.
No
The device description clearly states it is a "plastic disposable attachment" and a "plastic disposable item comprising a housing (body) that holds two plastic shafts". This indicates a physical, hardware-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is used for the professional prophylaxis treatment of patient's teeth by a dentist or hygienist. This is a direct treatment/cleaning procedure performed on the patient's body.
- Device Description: The description details a mechanical device used for cleaning teeth with a cup or brush. It does not involve analyzing samples from the body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The device is a plastic disposable attachment for use in conjunction with a slow speed handpiece, used during the professional prophylaxis treatment of patient's teeth by a dentist or hygienist.
For single use by Dental Professional in cleaning patient's teeth.
Our disposable prophylaxis angle is intended as a single use device used by : Dental Professional, either a Dentist or a Dental Hygienist to assist in the cleaning process of patient's teeth. It is intended for a single patient and :hould be discarded after each patient.
Product codes (comma separated list FDA assigned to the subject device)
EGS
Device Description
Plastic disposable item comprising a housing (body) that holds two plastic shafts aligned at 90 degrees (right angle) to each other that rotate a cup or brush.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by a dentist or hygienist.
Dental Professional, either a Dentist or a Dental Hygienist
Dental Office/Operatory
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)
The St. George Technology, Inc. Perfection Plus Disposable Prophy Angles have been extensively tested in in-vitro environments for fit, wear, duration of performance, strength, and durability.
In all criteria the St. George Technology, Inc. Perfection Plus Disposable Prophy Angle performed satisfactorily when compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Young Dental Manufacturing Disposable Prophy Angle, 510(k) 790722
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
Koz3953
11:40:00
ST. GEORGE TECHNOLOGY, INC.
FEB 1 4 2003
1
I'remarket Notification [510(k)] Summary
| Submitted by: | St. George Technology, Inc. |
|---|---|
| Contact Person: | Vernon Watkins |
| Address: | P.O. Box 2849 |
| Wilmington, NC 28402 | |
| USA | |
| Telephone: | (910) 397-0781 |
| Fax: | (910) 397-0791 |
| E-mail: | Vwatkins@byegeorge.com |
| Date Prepared: | November 2002 |
| Trade Name: | St. George Technology, Inc. Perfection Plus Disposable |
| Prophy Angles | |
| Common Name: | Disposable Prophy Angles (DPA's) |
| Classification Name: | Dental Contra and Right-Angle Handpiece Attachment |
| Predicate Device: | Young Dental Manufacturing Disposable Prophy Angle |
| Description Of Device: | Plastic disposable item comprising a housing (body) that |
| holds two plastic shafts aligned at 90 degrees (right angle) | |
| to each other that rotate a cup or brush. | |
| Intended Use: | The device is a plastic disposable attachment for use in |
| conjunction with a slow speed handpiece, used during the | |
| professional prophylaxis treatment of patient's teeth by a | |
| dentist or hygienist. |
1
Image /page/1/Picture/0 description: The image is a black and white logo. The logo is a diamond shape with a stylized image of a horse inside. The horse is white and the background of the diamond is black. There is a registered trademark symbol at the bottom right of the diamond.
ST. GEORGE TECHNOLOGY, INC.
´ `echnological Characteristics Compared With Predicate Device:
| Device 1 | St. George Technology | |
|---|---|---|
| Young Manufacturing DPA | Perfection Plus DPA | |
| 510(k) 790722 | ||
| Indications for Use | For single use by Dental Professional in | |
| cleaning patient's teeth. | Same | |
| Target Population | Dentists and Hygienists | Same |
| Design | Plastic one-piece housing (outer body) | |
| holding 2 internal shafts aligned at 90 | ||
| degree (right angle) to each other. Tip | ||
| fitted with a rubber cup or brush to clean | ||
| teeth. | Same | |
| Materials | Two types of plastic with either a rubber | |
| cup or brush fitted at the cleaning tip. | Same | |
| Performance | To be able to perform a full cleaning | |
| procedure. | Same | |
| Sterility | Non Sterile | Same |
| Biocompatibility | Have caused concern with latex allergies | |
| due to cup material. | Non latex material used on all | |
| cups - Improvement | ||
| Mechanical Safety | Robust construction to withstand forces | |
| involved in a cleaning. | Same | |
| Energy | ||
| Used/Delivered | Rotation of the cleaning device cup/brush | |
| tip provided by a slow speed hand piece | Same | |
| Compatibility with | ||
| other devices | Designed to fit securely onto most | |
| available ISO fitting standard slow speed | ||
| hand pieces | Same | |
| Where Used | Dental Office/Operatory | Same |
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Image /page/2/Picture/0 description: The image is a black and white logo. The logo is a diamond shape with a carousel horse inside. The carousel horse is white and the background is black. There is a registered trademark symbol at the bottom of the diamond.
ST. GEORGE TECHNOLOGY, INC.
↑ Ion-Clinical Performance:
The St. George Technology, Inc. Perfection Plus Disposable Prophy Angles have been extensively tested in in-vitro environments for fit, wear, duration of performance, strength, and durability.
Conclusion From l Non Clinical Test:
In all criteria the St. George Technology, Inc. Perfection Plus Disposable Prophy Angle performed satisfactorily when compared to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 4 2003
Mr. Vernon Watkins President St. George Technology, Incorporated P.O. Box 2849 Wilmington, North Carolina 28402-2849
Re: K023953
Trade/Device Name: St. George Technology, Inc. Perfection Plus Disposable Prophy Angles Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EGS Dated: November 26, 2002 Received: November 27, 2002
Dear Mr. Watkins:
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. Watkins
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 (301) 594-4613. Also, please 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/dsma/dsmamain.html
Sincerely yours,
Susan Kunner
Susan Runner, DDS, MA Interim 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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Image /page/5/Picture/0 description: The image is a black and white logo. The logo is a diamond shape with a carousel horse inside. The carousel horse is white and the background is black. There is a registered trademark symbol at the bottom of the diamond.
ST. GEORGE TECHNOLOGY, INC.
Statement of Indications for Use
()ur disposable prophylaxis angle is intended as a single use device used by : Dental Professional, either a Dentist or a Dental Hygienist to assist in the cleaning process of patient's teeth. It is intended for a single patient and :hould be discarded after each patient.
Ken Muly for nsn
(Division Sign-C v. General Hospital. Division of Anesthesiology Infection Control, Dental I
510(k) Number. K023953