510(k) · Cleared
Recalled · 2003Tradition P, Push Button Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midwest Dental Products Corp. · EFB Handpiece, Air-Powered, Dental
Cleared on Oct 11, 1996 after a 66-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Oct 11, 1996
- Review
- 66 days
- Class
- Class I
- Product code
- EFB
- Recalls
- 3
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK963050 Tradition P, Push Button HandpieceMidwest Dental Products Corp. · 1996
- Descendant · cites it directly · 0 of its ownK983168 Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece…Ora Innovations, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K983168Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece, Model #'S Avant HS…Ora Innovations, Inc. · 1998 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963050 | Tradition P, Push Button Handpiece | Midwest Dental Products Corp. | 1996 | — |
| +1 | K983168 | Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece, Model #'S… | Ora Innovations, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K983168 | Avant High Speed Handpiece, Avant Fiber Optic High Speed Handpiece, Model #'S Avant HS… | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2003 | Not classified | Z-0154-04 | Other | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
| Oct 14, 2003 | Not classified | Z-0155-04 | Other | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
| Oct 14, 2003 | Not classified | Z-0156-04 | Other | Small cracks in the dental handpiece's chuck could allow the dental burs to drift out of the chuck over time. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K983168 (Ora Innovations, Inc., 1998) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K963050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963050: Tradition P, Push Button Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963050
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026