510(k) · Cleared
ClearedSaf (Self Adjusting File)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Redent-Nova, Ltd. · EFB Handpiece, Air-Powered, Dental
Cleared on Jan 14, 2010 as substantially equivalent to K962031 (Tycom Dental, 1996) and 1 other predicate after a 113-day review. Its family tree reaches back 2 generations to 1993.
- Decided
- Jan 14, 2010
- Review
- 113 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K933582 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933582 | Profile Series 29 Files | Tulsa Dental Products, Ltd. | 1993 | — |
| −1 | K962031 | Quantec Series 2000 Endodontic Files | Tycom Dental | 1996 | — |
| 0 (this device) | K092933 | Saf (Self Adjusting File) | Redent-Nova, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
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 EFB? 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 EFB device
- #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K962031 | Quantec Series 2000 Endodontic Files | 1996 |
| * | K933582 | Profile Series 29 FilesSummary page 2…Kole933 Predicate Devices ProTaper - Dentsply Tulsa Dental (510(k) exempt) Quantec Series 2000 - Tyco Dental (K96203 I) Profile 29 - Dentsply Tulsa Dental (K933582) Intended Use I Indications for Use The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for… | 1993 |
| * | — | ProTaper Named without a submission number |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 13.6 years on median.
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K962031.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · EFB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EFB
209in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFB
No recall names EFB since 2007.
Adverse event reports per year · EFB
83in 2025
MAUDE reports naming product code EFB, 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 | 12 | 61 | 0 | 13 |
| 2008 | 7 | 97 | 0 | 19 |
| 2009 | 11 | 120 | 0 | 40 |
| 2010 | 8 | 116 | 0 | 78 |
| 2011 | 4 | 168 | 0 | 96 |
| 2012 | 8 | 130 | 0 | 97 |
| 2013 | 3 | 207 | 0 | 61 |
| 2014 | 7 | 200 | 0 | 73 |
| 2015 | 7 | 296 | 0 | 87 |
| 2016 | 3 | 205 | 0 | 122 |
| 2017 | 7 | 246 | 0 | 153 |
| 2018 | 3 | 210 | 0 | 81 |
| 2019 | 3 | 348 | 0 | 117 |
| 2020 | 5 | 259 | 0 | 94 |
| 2021 | 2 | — | 0 | 123 |
| 2022 | 5 | 430 | 0 | 157 |
| 2023 | 4 | 158 | 0 | 116 |
| 2024 | 5 | 209 | 0 | 104 |
| 2025 | 1 | — | 0 | 83 |
| 2026 | 4 | 252 | 0 | — |
What is it indicated for?
The Self Adjusting file (SAF) is a mechanically operated endodontic file to be used for cleaning and shaping of root canals, as part of the procedure of root canal treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092933 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092933: Saf (Self Adjusting File).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092933
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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