510(k) · Cleared
ClearedGyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bien Air USA, Inc. · EFB Handpiece, Air-Powered, Dental
Cleared on Dec 10, 1998 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.
- Decided
- Dec 10, 1998
- Review
- 90 days
- Class
- Class I
- Product code
- EFB
- Recalls
- None
- Predicates
- 0
21 later devices descend from it, 4 citing it directly.
- This deviceK983183 Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora…Bien Air USA, Inc. · 1998
- Descendant · cites it directly · 10 of its ownK031145 Estylus Electric Motor SystemDentsply Intl. · 2003
- Descendant · 2 generations on · 8 of its ownK072989 Axis SystemDentsply Intl., Inc. · 2008
- Descendant · 3 generations on · 7 of its ownK143704 Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015
- Descendant · cites it directly · 7 of its ownK083101 Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight…Sable Industries, Inc. · 2009
- Descendant · 4 generations on · 6 of its ownK162926 Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K031145Estylus Electric Motor SystemDentsply Intl. · 2003 · cites it directly10descendants
- K072989Axis SystemDentsply Intl., Inc. · 2008 · 2 generations on8descendants
- K143704Advanced Air SystemW&H Dentalwerk Buermoos GmbH · 2015 · 3 generations on7descendants
- K083101Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight NoseconesSable Industries, Inc. · 2009 · cites it directly7descendants
- K162926Air-Powered Handpieces and Handpiece AttachmentsW&H Dentalwerk Burmoos GmbH · 2017 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983183 | Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon… | Bien Air USA, Inc. | 1998 | — |
| +1 | K031145 | Estylus Electric Motor System | Dentsply Intl. | 2003 | — |
| +2 | K072989 | Axis System | Dentsply Intl., Inc. | 2008 | — |
| +3 | K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH | 2015 | — |
| +1 | K083101 | Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight Nosecones | Sable Industries, Inc. | 2009 | — |
| +4 | K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Burmoos GmbH | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2026 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (21)
See all 214 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K031145 (Dentsply Intl., 2003) has gone furthest, with 10 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/K983183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983183: Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983183
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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