510(k) · Cleared
ClearedCocoon Hygienist
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · EIA Unit, Operative Dental
Cleared on Aug 19, 2004 as substantially equivalent to K020833 (Boyd Industries, Inc., 2002) after a 171-day review. Its family tree reaches back 1 generation to 2002. 13 later devices descend from it.
- Decided
- Aug 19, 2004
- Review
- 171 days
- Class
- Class I
- Product code
- EIA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020833 (2002). 13 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK020833 Boyd Delivery UnitBoyd Industries, Inc. · 2002
- This deviceK040529 Cocoon HygienistSatelec · 2004
- Descendant · cites it directly · 12 of its ownK072030 Implant CenterSatelec - Acteon Group · 2007
- Descendant · 2 generations on · 11 of its ownK091252 Implant Center 2Satelec · 2009
- Descendant · 3 generations on · 8 of its ownK100410 Piezoelectric SystemSatelec · 2010
- Descendant · 4 generations on · 6 of its ownK132848 Piezosurgery FlexMectron S.P.A. · 2013
- Descendant · 4 generations on · 2 of its ownK172464 XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K072030Implant CenterSatelec - Acteon Group · 2007 · cites it directly12descendants
- K091252Implant Center 2Satelec · 2009 · 2 generations on11descendants
- K100410Piezoelectric SystemSatelec · 2010 · 3 generations on8descendants
- K132848Piezosurgery FlexMectron S.P.A. · 2013 · 4 generations on6descendants
- K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020833 | Boyd Delivery Unit | Boyd Industries, Inc. | 2002 | — |
| 0 (this device) | K040529 | Cocoon Hygienist | Satelec | 2004 | — |
| +1 | K072030 | Implant Center | Satelec - Acteon Group | 2007 | — |
| +2 | K091252 | Implant Center 2 | Satelec | 2009 | — |
| +3 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| +4 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| +4 | K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K020833 | Boyd Delivery UnitSummary page 1…cation of Predicate Devices The Cocoon Hygienist is substantially equivalent to the predicate device by Boyd Industries, Inc., Boyd Delivery Units (K020833) previously cleared by FDA and currently marketed. 0. Device Description The Cocoon Hygienist is a… | 2002 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072030 | Implant Center | 2007 | 12 |
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.
- Of its descendants, K072030 (Satelec - Acteon Group, 2007) has gone furthest, with 12 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?
The Cocoon® Hygienist is a dental operative unit intended to supply utilities to and serve as a base for dental tools and accessories for use by dental professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040529 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040529: Cocoon Hygienist.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040529
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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