510(k) · Cleared
ClearedSynea Fusion Handpieces (Intensiv & Profin)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
W&H Dentalwerk Bürmoos GmbH · EFB Handpiece, Air-Powered, Dental
Cleared on Feb 28, 2025 as substantially equivalent to K082827 (A-Dec, Inc., 2009) after a 218-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Feb 28, 2025
- Review
- 218 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K082827 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK082827 A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece AttachmentA-Dec, Inc. · 2009
- This deviceK242179 Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbH · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K082827 | A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece Attachment | A-Dec, Inc. | 2009 | — |
| 0 (this device) | K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | 2025 | — |
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? (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 |
|---|---|---|---|
| * | K082827 | A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece AttachmentSummary page 5…ec/W&H Synea Profin reciprocating contra-angle handpiece attachments” Predicate Devices 510(k) Number: K082827 (Decision Date: January 7th, 2009) Manufacturer: W&H Dentalwerk Bürmoos GmbH… | 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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K082827.
How does its category compare?
All EFB devicesEFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 reciprocating/oscillating contra-angle handpieces are for the following applications:
Preparation, removing protrusions or excess of filling materials and cements, finishing and polishing in the interdental, supragingival and subgingival regions, plaque removal and IPR (interproximal reduction) in orthodontics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242179 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242179: Synea Fusion Handpieces (Intensiv & Profin).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242179
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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