510(k) · Cleared
ClearedPiezotome Solo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Satelec - Acteon, Inc. · DZI Drill, Bone, Powered
Cleared on Feb 3, 2012 as substantially equivalent to K091252 (Satelec, 2009) after a 189-day review. Its family tree reaches back 4 generations to 2002. 1 later device descends from it.
- Decided
- Feb 3, 2012
- Review
- 189 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K020833 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK020833 Boyd Delivery UnitBoyd Industries, Inc. · 2002
- 3 generations backK040529 Cocoon HygienistSatelec · 2004
- 2 generations backK072030 Implant CenterSatelec - Acteon Group · 2007
- 1 generation backK091252 Implant Center 2Satelec · 2009
- This deviceK112188 Piezotome SoloSatelec - Acteon, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK172137 Piezotome CubeSatelec - Acteon Group · 2018
Most influential descendants
Showing 1 of 1 · See all- K172137Piezotome CubeSatelec - Acteon Group · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K020833 | Boyd Delivery Unit | Boyd Industries, Inc. | 2002 | — |
| −3 | K040529 | Cocoon Hygienist | Satelec | 2004 | — |
| −2 | K072030 | Implant Center | Satelec - Acteon Group | 2007 | — |
| −1 | K091252 | Implant Center 2 | Satelec | 2009 | — |
| 0 (this device) | K112188 | Piezotome Solo | Satelec - Acteon, Inc. | 2012 | — |
| +1 | K172137 | Piezotome Cube | Satelec - Acteon Group | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K091252 | Implant Center 2Summary page 2…Trade Namne Pran n1()iumber DtCleare IMPLANT CENTER 2 ISATELEC DZI K091252 IJuly 22, 209 4 - Description of the Device The New Device is a dental operative unit that supplies utilitie… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172137 | Piezotome Cube | 2018 | 0 |
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 10 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K172137 (Satelec - Acteon Group, 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K091252.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 PIEZOTOME SOLO (or PIEZOTOME SOLO LED available in option) is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
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/K112188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112188: Piezotome Solo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112188
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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