510(k) · Cleared
ClearedImplant Center
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec - Acteon Group · DZI Drill, Bone, Powered
Cleared on Nov 19, 2007 as substantially equivalent to K040529 (Satelec, 2004) after a 118-day review. Its family tree reaches back 2 generations to 2002. 12 later devices descend from it.
- Decided
- Nov 19, 2007
- Review
- 118 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020833 (2002). 12 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK020833 Boyd Delivery UnitBoyd Industries, Inc. · 2002
- 1 generation backK040529 Cocoon HygienistSatelec · 2004
- This deviceK072030 Implant CenterSatelec - Acteon Group · 2007
- Descendant · cites it directly · 11 of its ownK091252 Implant Center 2Satelec · 2009
- Descendant · 2 generations on · 8 of its ownK100410 Piezoelectric SystemSatelec · 2010
- Descendant · 3 generations on · 6 of its ownK132848 Piezosurgery FlexMectron S.P.A. · 2013
- Descendant · 3 generations on · 2 of its ownK172464 XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018
- Descendant · 4 generations on · 2 of its ownK153743 Piezosurgery PlusMectron S.P.A. · 2016
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K091252Implant Center 2Satelec · 2009 · cites it directly11descendants
- K100410Piezoelectric SystemSatelec · 2010 · 2 generations on8descendants
- K132848Piezosurgery FlexMectron S.P.A. · 2013 · 3 generations on6descendants
- K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018 · 3 generations on2descendants
- K153743Piezosurgery PlusMectron S.P.A. · 2016 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020833 | Boyd Delivery Unit | Boyd Industries, Inc. | 2002 | — |
| −1 | K040529 | Cocoon Hygienist | Satelec | 2004 | — |
| 0 (this device) | K072030 | Implant Center | Satelec - Acteon Group | 2007 | — |
| +1 | K091252 | Implant Center 2 | Satelec | 2009 | — |
| +2 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| +3 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| +3 | K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | 2018 | — |
| +4 | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 DZI? 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 DZI device
- #1 K253776 Implantmed Plus II & Piezomed Plus II Modulescore 12.1 · 3 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 |
|---|---|---|---|
| * | K040529 | Cocoon HygienistSummary page 1…Device Applicant 510()No. DateCleared Cocoon Hygienist Satelec K040529 August 19, 2004 The Satelec Implant Center is substantially equivalent to the predicate device by… | 2004 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091252 | Implant Center 2 | 2009 | 11 |
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?
- The line of descent spans 5 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K091252 (Satelec, 2009) has gone furthest, with 11 descendants of its own.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DZI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZI
300in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZI
1in 2009
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZI
39in 2025
MAUDE reports naming product code DZI, 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 | 2 | — | 0 | 53 |
| 2008 | 4 | 171 | 0 | 45 |
| 2009 | 5 | 220 | 1 | 22 |
| 2010 | 0 | — | 0 | 15 |
| 2011 | 2 | — | 0 | 42 |
| 2012 | 4 | 191 | 0 | 25 |
| 2013 | 0 | — | 0 | 57 |
| 2014 | 1 | — | 0 | 50 |
| 2015 | 3 | 123 | 0 | 39 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 3 | 290 | 0 | 73 |
| 2019 | 0 | — | 0 | 50 |
| 2020 | 3 | 300 | 0 | 55 |
| 2021 | 0 | — | 0 | 84 |
| 2022 | 0 | — | 0 | 63 |
| 2023 | 1 | — | 0 | 63 |
| 2024 | 2 | — | 0 | 58 |
| 2025 | 1 | — | 0 | 39 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The intended use of the Satelec Implant Center is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072030 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072030: Implant Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072030
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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