510(k) · Cleared
ClearedPiezosurgery Touch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mectron S.P.A. · DZI Drill, Bone, Powered
Cleared on Dec 6, 2012 after a 127-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Dec 6, 2012
- Review
- 127 days
- Class
- Class II
- Product code
- DZI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK122322 Piezosurgery TouchMectron S.P.A. · 2012
- Descendant · cites it directly · 2 of its ownK151248 Piezosurgery WhiteMectron S.P.A. · 2015
- Descendant · cites it directly · 1 of its ownK133488 PiezomedW&H Dentalwerk Buermoos GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK253776 Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbH · 2026
- Descendant · cites it directly · 0 of its ownK242432 MT-BoneMectron S.P.A. · 2024
- Descendant · 2 generations on · 0 of its ownK171326 Piezosurgery WhiteMectron S.P.A. · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K151248Piezosurgery WhiteMectron S.P.A. · 2015 · cites it directly2descendants
- K133488PiezomedW&H Dentalwerk Buermoos GmbH · 2014 · cites it directly1descendant
- K253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbH · 2026 · 2 generations on0descendants
- K242432MT-BoneMectron S.P.A. · 2024 · cites it directly0descendants
- K171326Piezosurgery WhiteMectron S.P.A. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122322 | Piezosurgery Touch | Mectron S.P.A. | 2012 | — |
| +1 | K151248 | Piezosurgery White | Mectron S.P.A. | 2015 | — |
| +1 | K133488 | Piezomed | W&H Dentalwerk Buermoos GmbH | 2014 | — |
| +2 | K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | 2026 | — |
| +1 | K242432 | MT-Bone | Mectron S.P.A. | 2024 | — |
| +2 | K171326 | Piezosurgery White | Mectron S.P.A. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (6)
4 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?
- Of its descendants, K151248 (Mectron S.P.A., 2015) has gone furthest, with 2 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. 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?
Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for * Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures; * Scaling applications, including: a Scaling: All general procedures for removal of supragingival and interdental calculus & plaque…
Read the full statement (111 words)
Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for
* Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures;
* Scaling applications, including:
a Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;
a Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning:
* Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation;
* Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122322: Piezosurgery Touch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122322
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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