510(k) · Cleared
ClearedImplant Center 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec · DZI Drill, Bone, Powered
Cleared on Jul 22, 2009 as substantially equivalent to K072030 (Satelec - Acteon Group, 2007) after an 84-day review. Its family tree reaches back 3 generations to 2002. 11 later devices descend from it.
- Decided
- Jul 22, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K020833 (2002). 11 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK020833 Boyd Delivery UnitBoyd Industries, Inc. · 2002
- 2 generations backK040529 Cocoon HygienistSatelec · 2004
- 1 generation backK072030 Implant CenterSatelec - Acteon Group · 2007
- This deviceK091252 Implant Center 2Satelec · 2009
- Descendant · cites it directly · 8 of its ownK100410 Piezoelectric SystemSatelec · 2010
- Descendant · 2 generations on · 6 of its ownK132848 Piezosurgery FlexMectron S.P.A. · 2013
- Descendant · 2 generations on · 2 of its ownK172464 XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018
- Descendant · 3 generations on · 2 of its ownK153743 Piezosurgery PlusMectron S.P.A. · 2016
- Descendant · cites it directly · 1 of its ownK112188 Piezotome SoloSatelec - Acteon, Inc. · 2012
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K100410Piezoelectric SystemSatelec · 2010 · cites it directly8descendants
- K132848Piezosurgery FlexMectron S.P.A. · 2013 · 2 generations on6descendants
- K172464XD880A Ultrasonic Osteotomy Surgical SystemMorley Research Consortium · 2018 · 2 generations on2descendants
- K153743Piezosurgery PlusMectron S.P.A. · 2016 · 3 generations on2descendants
- K112188Piezotome SoloSatelec - Acteon, Inc. · 2012 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K020833 | Boyd Delivery Unit | Boyd Industries, Inc. | 2002 | — |
| −2 | K040529 | Cocoon Hygienist | Satelec | 2004 | — |
| −1 | K072030 | Implant Center | Satelec - Acteon Group | 2007 | — |
| 0 (this device) | K091252 | Implant Center 2 | Satelec | 2009 | — |
| +1 | K100410 | Piezoelectric System | Satelec | 2010 | — |
| +2 | K132848 | Piezosurgery Flex | Mectron S.P.A. | 2013 | — |
| +2 | K172464 | XD880A Ultrasonic Osteotomy Surgical System | Morley Research Consortium | 2018 | — |
| +3 | K153743 | Piezosurgery Plus | Mectron S.P.A. | 2016 | — |
| +1 | K112188 | Piezotome Solo | Satelec - Acteon, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K072030 | Implant CenterSummary page 1…dentification of the Predicate Device Device Appicpan~ 510(k) No. Date Cleared Implant Center Satelec K072030 11 / 19 / 2007 The Satelec Implant Center 2 is substantially equivalent to the predicate device by Satelec, the Im… | 2007 |
What descends from it? (11)
See all 112 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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K100410 (Satelec, 2010) has gone furthest, with 8 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. 2009, 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 2 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/K091252 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091252: Implant Center 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091252
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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