Perfection Plus Disposable Prophy Angle
by St. George Technology, Inc.
510(k) K023953
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK023953 | Date14 Feb 2003 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Full name
- St. George Technology, Inc Perfection Plus Disposable Prophy Angle
- 510(k) Number
- FDA Product Code
- EGS
- Device Class
- Class I
- Regulation
- 21 CFR Part 872.4200
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Perfection Plus Disposable Prophy Angle is a contra- and right-angle attachment for dental handpieces, designed for polishing and prophylaxis procedures. It is classified as a Class I dental device and functions as an accessory to handpieces, enabling precise cleaning and smoothing of tooth surfaces during routine dental care.
This device is supplied as a single-use, disposable item and is intended for use in dental clinics and offices. It is not sterile upon packaging but is intended to be used in a manner that maintains aseptic conditions. The Perfection Plus Prophy Angle is authorised under FDA 510K clearance, MDD, and MDR compliance, with a registration number of 872.4200. Multiple model and reference codes are associated with its regulatory submissions, ensuring adherence to dental device standards.
Other devices from St. George Technology, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Perfection Plus Disposable Prophy Angle in dental procedures?
The Perfection Plus Disposable Prophy Angle is designed as a contra- and right-angle attachment for dental handpieces, specifically for polishing and prophylaxis procedures. It enables precise cleaning and smoothing of tooth surfaces during routine dental care, acting as an accessory to handpieces to enhance precision and efficiency.
Is the Perfection Plus Disposable Prophy Angle intended for single-use or reusable applications?
The Perfection Plus Disposable Prophy Angle is explicitly labeled as a single-use, disposable item. This design ensures hygiene and reduces the risk of cross-contamination in dental clinics and offices.
How is the Perfection Plus Disposable Prophy Angle supplied, and is it sterile upon packaging?
The device is supplied as a non-sterile item, meaning it is not sterile upon packaging. However, it is intended to be used in a manner that maintains aseptic conditions during dental procedures, ensuring patient safety.
What regulatory pathways has the Perfection Plus Disposable Prophy Angle undergone, and what does this mean for its use?
The Perfection Plus Disposable Prophy Angle has been authorized under FDA 510K clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation). This indicates compliance with stringent regulatory standards for dental devices, ensuring its safety and performance for use in polishing and prophylaxis procedures.
Are there multiple models or reference codes associated with this device, and what does this imply for compatibility?
Yes, the Perfection Plus Disposable Prophy Angle is associated with multiple FEI numbers and registration codes, reflecting various regulatory submissions. This implies that the device may be compatible with a range of dental handpieces, though compatibility should always be verified with the specific handpiece manufacturer to ensure proper function and safety.