510(k) · Cleared
ClearedRDT3 Handpiece Head Model RDT3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Redent Nova, Ltd. · EFA Handpiece, Belt And/Or Gear Driven, Dental
Cleared on Jul 27, 2010 as substantially equivalent to K092446 (Kaltenbach & Voigt GmbH & Co., 2009) after a 92-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Jul 27, 2010
- Review
- 92 days
- Class
- Class I
- Product code
- EFA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K896878 (1990). 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 | K896878 | Handpiece System with Motor (Several Models) | Micro Motors, Inc. | 1990 | — |
| −1 | K092446 | Intra Lux Head 3 Ldsy | Kaltenbach & Voigt GmbH & Co. | 2009 | — |
| 0 (this device) | K101172 | RDT3 Handpiece Head Model RDT3 | Redent Nova, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 EFA? 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 EFA device
- #1 K192809 Dental Handpiecescore 3.5 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K092446 | Intra Lux Head 3 LdsySummary page 1…EFA Classification regulation: 872.4200 Class: I Panel: Dental Predicate Devices Intra Lux Head 3LDSY (K092446) Intended Use / Indications for Use RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use… | 2009 |
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 20 years and passes through 3 companies; a new generation was cleared every 19.7 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All EFA devicesEFA Handpiece, Belt And/Or Gear Driven, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · EFA
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · EFA
78in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFA
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFA
4in 2025
MAUDE reports naming product code EFA, 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 | 1 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 4 | 78 | 0 | 0 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
RDT3 Handpiece Head is a reciprocating dental handpiece attachment intended for use in root canal preparations using the Self Adjusting File, SAF (K092933) (ReDent Nova LTD., Ra'anana Israel).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101172: RDT3 Handpiece Head Model RDT3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101172
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