510(k) · Cleared
ClearedA-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H Alegra Handpiece Attachment, Model HE-43
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A-Dec, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Jan 15, 2009 after a 120-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jan 15, 2009
- Review
- 120 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK082716 A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98…A-Dec, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK120218 Tek Usa E-Generator Integrated Led Handpiece (High & Low Speed Air…Palm Beach Dental Supply D/B/A Tek USA · 2012
Most influential descendants
Showing 1 of 1 · See all- K120218Tek Usa E-Generator Integrated Led Handpiece (High & Low Speed Air Turbnine Dental…Palm Beach Dental Supply D/B/A Tek USA · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082716 | A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H… | A-Dec, Inc. | 2009 | — |
| +1 | K120218 | Tek Usa E-Generator Integrated Led Handpiece (High & Low Speed Air Turbnine… | Palm Beach Dental Supply D/B/A Tek USA | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K120218 | Tek Usa E-Generator Integrated Led Handpiece (High & Low Speed Air Turbnine Dental… | 2012 | 0 |
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?
- Of its descendants, K120218 (Palm Beach Dental Supply D/B/A Tek USA, 2012) 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. 2009, 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 A-dec/W&H Alegra Air-Driven Highspeed Haridpiece is an air-powered dental
handpiece for use in general dentistry. This device is designed for removing carious
material and excess filling material, cavity and crown preparation, root canal preparations,
finishing tooth preparations, restorations and polishing teeth.
The A-dec/W&H Alegra Handpiece Attachment is powered by either an air-motor or
electric micromotor for use in general dentistry. This device is designed for removing
carious material and excess filling material, cavity and crown preparation, root canal
preparations, finishing tooth preparations, restorations and polishing teeth.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K082716 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082716: A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H Alegra Handpiece Attachment, Model HE-43.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082716
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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