510(k) · Cleared
ClearedST. George Technology, Inc Perfection Plus Disposable Prophy Angle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
St. George Technology, Inc. · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Feb 14, 2003 as substantially equivalent to K790722 (Young Dental Manufacturing Co. 1, LLC, 1979) after a 79-day review. Its family tree reaches back 1 generation to 1979.
- Decided
- Feb 14, 2003
- Review
- 79 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K790722 (1979). No later device cites it as a predicate yet.
- Root · 1 generation backK790722 Prophylaxis AngleYoung Dental Manufacturing Co. 1, LLC · 1979
- This deviceK023953 ST. George Technology, Inc Perfection Plus Disposable Prophy AngleSt. George Technology, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K790722 | Prophylaxis Angle | Young Dental Manufacturing Co. 1, LLC | 1979 | — |
| 0 (this device) | K023953 | ST. George Technology, Inc Perfection Plus Disposable Prophy Angle | St. George Technology, Inc. | 2003 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EGS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EGS device
- #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K790722 | Prophylaxis AngleSummary page 2…St. George Technology Young Manufacturing DPA Perfection Plus DPA 510(k) 790722 Indications for Use For single use by Dental Professional in Same ---___ cleaning patient's teeth. Targei Po… | 1979 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K790722.
How does its category compare?
All EGS devicesEGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EGS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGS
189in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGS
82in 2025
MAUDE reports naming product code EGS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 1 | — | 0 | 45 |
| 2010 | 2 | — | 0 | 74 |
| 2011 | 3 | 104 | 0 | 2 |
| 2012 | 3 | 288 | 0 | 3 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 38 |
| 2015 | 3 | 245 | 0 | 166 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 2 | — | 0 | 316 |
| 2018 | 1 | — | 0 | 230 |
| 2019 | 3 | 276 | 0 | 219 |
| 2020 | 1 | — | 0 | 191 |
| 2021 | 1 | — | 0 | 294 |
| 2022 | 4 | 189 | 0 | 279 |
| 2023 | 1 | — | 1 | 115 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 82 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Our disposable prophylaxis angle is intended as a single use device used by
A 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
should be discarded after each patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023953: ST. George Technology, Inc Perfection Plus Disposable Prophy Angle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023953
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026