510(k) · Cleared
ClearedPiezotome Cube
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 May 3, 2018 as substantially equivalent to K112188 (Satelec - Acteon, Inc., 2012) after a 290-day review. Its family tree reaches back 5 generations to 2002.
- Decided
- May 3, 2018
- Review
- 290 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K020833 (2002). No later device cites it as a predicate yet.
- Root · 5 generations backK020833 Boyd Delivery UnitBoyd Industries, Inc. · 2002
- 4 generations backK040529 Cocoon HygienistSatelec · 2004
- 3 generations backK072030 Implant CenterSatelec - Acteon Group · 2007
- 2 generations backK091252 Implant Center 2Satelec · 2009
- 1 generation backK112188 Piezotome SoloSatelec - Acteon, Inc. · 2012
- This deviceK172137 Piezotome CubeSatelec - Acteon Group · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K020833 | Boyd Delivery Unit | Boyd Industries, Inc. | 2002 | — |
| −4 | K040529 | Cocoon Hygienist | Satelec | 2004 | — |
| −3 | K072030 | Implant Center | Satelec - Acteon Group | 2007 | — |
| −2 | K091252 | Implant Center 2 | Satelec | 2009 | — |
| −1 | K112188 | Piezotome Solo | Satelec - Acteon, Inc. | 2012 | — |
| 0 (this device) | K172137 | Piezotome Cube | Satelec - Acteon Group | 2018 | — |
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 |
|---|---|---|---|
| * | K112188 | Piezotome SoloSummary page 5…Manufacturer Product Code 510(k) number Date Cleared PIEZOTOME SOLO SATELEC DZI K112188 Feb 03, 2012 PIEZOTOME SOLO LED IV –DEVICE DESCRIPTION SATELEC CUBE is an piezoelectric device that uses micro-vib… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All DZI devicesDZI Drill, Bone, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172137: Piezotome Cube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172137
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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