510(k) · Cleared
ClearedBoyd Delivery Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boyd Industries, Inc. · EIA Unit, Operative Dental
Cleared on Aug 8, 2002 after a 147-day review. The FDA summary names no predicate by number. 14 later devices descend from it.
- Decided
- Aug 8, 2002
- Review
- 147 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 1 citing it directly.
- This deviceK020833 Boyd Delivery UnitBoyd Industries, Inc. · 2002
- Descendant · cites it directly · 13 of its ownK040529 Cocoon HygienistSatelec · 2004
- Descendant · 2 generations on · 12 of its ownK072030 Implant CenterSatelec - Acteon Group · 2007
- Descendant · 3 generations on · 11 of its ownK091252 Implant Center 2Satelec · 2009
- Descendant · 4 generations on · 8 of its ownK100410 Piezoelectric SystemSatelec · 2010
- Descendant · 5 generations on · 6 of its ownK132848 Piezosurgery FlexMectron S.P.A. · 2013
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K040529Cocoon HygienistSatelec · 2004 · cites it directly13descendants
- K072030Implant CenterSatelec - Acteon Group · 2007 · 2 generations on12descendants
- K091252Implant Center 2Satelec · 2009 · 3 generations on11descendants
- K100410Piezoelectric SystemSatelec · 2010 · 4 generations on8descendants
- K132848Piezosurgery FlexMectron S.P.A. · 2013 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020833 | Boyd Delivery Unit | Boyd Industries, Inc. | 2002 | — |
| +1 | K040529 | Cocoon Hygienist | Satelec | 2004 | — |
| +2 | K072030 | Implant Center | Satelec - Acteon Group | 2007 | — |
| +3 | K091252 | Implant Center 2 | Satelec | 2009 | — |
| +4 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| +5 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 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 EIA? 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 EIA device
- #1 K231845 Dental unit Model: Marescore 14.4 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040529 | Cocoon Hygienist | 2004 | 13 |
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, K040529 (Satelec, 2004) has gone furthest, with 13 descendants of its own.
How does its category compare?
All EIA devicesEIA Unit, Operative Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EIA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EIA
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EIA
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EIA
47in 2025
MAUDE reports naming product code EIA, 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 | 3 | 90 | 0 | 0 |
| 2008 | 6 | 72 | 0 | 0 |
| 2009 | 3 | 109 | 0 | 0 |
| 2010 | 3 | 270 | 0 | 2 |
| 2011 | 5 | 150 | 0 | 3 |
| 2012 | 2 | — | 1 | 7 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 2 | — | 0 | 255 |
| 2015 | 7 | 214 | 0 | 452 |
| 2016 | 4 | 182 | 0 | 151 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 2 | — | 0 | 73 |
| 2019 | 2 | — | 0 | 68 |
| 2020 | 1 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 49 |
| 2022 | 3 | 265 | 0 | 44 |
| 2023 | 3 | 686 | 0 | 53 |
| 2024 | 3 | 251 | 0 | 53 |
| 2025 | 7 | 178 | 0 | 47 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Boyd delivery systems are intended for use by Dental Professionals for effective treatment of patients.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020833 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020833: Boyd Delivery Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020833
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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