510(k) · Cleared

Cleared

Piezosurgery White

K171326510(k) TraditionalCleared Apr 13, 2018343-day reviewClass II21 CFR 872.4120

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mectron S.P.A. · DZI Drill, Bone, Powered

Cleared on Apr 13, 2018 as substantially equivalent to K151248 (Mectron S.P.A., 2015) after a 343-day review. Its family tree reaches back 2 generations to 2012.

Decided: Apr 13, 2018
Review: 343 days
Class: Class II
Product code: DZI
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K122322 (2012). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK122322 Piezosurgery TouchMectron S.P.A. · 2012
1 generation backK151248 Piezosurgery WhiteMectron S.P.A. · 2015
This deviceK171326 Piezosurgery WhiteMectron S.P.A. · 2018

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K122322	Piezosurgery Touch	Mectron S.P.A.	2012	—
−1	K151248	Piezosurgery White	Mectron S.P.A.	2015	—
0 (this device)	K171326	Piezosurgery White	Mectron S.P.A.	2018	—

FIG. 1 — Lineage of K171326, 2012–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K151248	Piezosurgery White Summary page 4 …The Piezosurgery insert components are manufactured from stainless steels (ASTM F899). Primary Predicate: Piezosurgery White (MECTRON S.p.A – K151248) Page 4 Performa…	Mectron S.P.A.	2015	—

Also cleared against K151248: 1 other device →

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 6 years and passes through 1 company; a new generation was cleared every 2.7 years on median.
None of the 2 ancestors has a recall.
1 other device also cites its predicate K151248.

How does its category compare?

All DZI devices

DZI 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

2007high 5 (2009) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZI

300in 2020

2007high 300 (2020) · low 123 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZI

1in 2009

2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DZI

39in 2025

2007high 84 (2021) · low 15 (2010)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 Piezosurgery White 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: - Scaling: All general procedures for removal of supragingival and interdental calculus & plaque…

Read the full statement (112 words)

The Piezosurgery White 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:

- Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits;

- 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/K171326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K171326: Piezosurgery White.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171326

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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