510(k) · Cleared

Cleared

Piezotome

K060275510(k) TraditionalCleared May 3, 200690-day reviewClass II21 CFR 872.4850

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

Satelec · ELC Scaler, Ultrasonic

Cleared on May 3, 2006 as substantially equivalent to K050895 (Satelec, 2005) after a 90-day review. Its family tree reaches back 5 generations to 1995.

Decided: May 3, 2006
Review: 90 days
Class: Class II
Product code: ELC
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K942139 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK942139 Suprasson P MaxSatelec · 1995
4 generations backK961158 Suprasson P5 BoosterSatelec · 1996
3 generations backK972026 SP4044 & SP4055 Lux ModulesSatelec · 1997
2 generations backK033764 SP Newtron ModuleSatelec · 2004
1 generation backK050895 Surpasson P5 NewtronSatelec · 2005
This deviceK060275 PiezotomeSatelec · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K942139	Suprasson P Max	Satelec	1995	—
−4	K961158	Suprasson P5 Booster	Satelec	1996	—
−3	K972026	SP4044 & SP4055 Lux Modules	Satelec	1997	—
−2	K033764	SP Newtron Module	Satelec	2004	—
−1	K050895	Surpasson P5 Newtron	Satelec	2005	—
0 (this device)	K060275	Piezotome	Satelec	2006	—

FIG. 1 — Lineage of K060275, 1995–2006Source: 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 ELC? 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 ELC device

#1 K260773 Varios Combi Pro2score 12.5 · 6 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
*	K050895	Surpasson P5 Newtron Summary page 1 …cation of Predicate Device Device Applicant 510(k) No. Date Cleared Suprasson® P5 Newtron Satelec K050895 April 20, 2005 The Satelec PiezotomeTM is substantially equivalent to the predicate device by Satelec, the S…	Satelec	2005	—

Also cleared against K050895: 6 other devices →

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 11 years and passes through 1 company; a new generation was cleared every 1.1 years on median.
None of the 5 ancestors has a recall.
6 other devices also cite its predicate K050895.

How does its category compare?

All ELC devices

ELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ELC

2in 2025

2007high 13 (2013) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ELC

104in 2024

2007high 258 (2023) · low 88 (2016)2026

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

Recalls per year · ELC

2in 2022

2007high 2 (2022) · low 0 (2007)2026

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

Adverse event reports per year · ELC

284in 2025

2007high 356 (2017) · low 3 (2012)2025

MAUDE reports naming product code ELC, 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	6	92	0	12
2008	4	216	0	58
2009	4	121	0	108
2010	4	201	0	79
2011	3	122	0	5
2012	1	—	0	3
2013	13	174	0	6
2014	6	193	0	37
2015	5	150	0	135
2016	3	88	0	169
2017	2	—	0	356
2018	1	—	0	289
2019	4	192	0	302
2020	1	—	0	164
2021	3	196	0	166
2022	2	—	2	165
2023	5	258	0	210
2024	4	104	0	219
2025	2	—	0	284
2026	2	—	0	—

What is it indicated for?

Periodontics Endodontics Scaling Prosthesis Please refer to the attached listing for a detailed description. Periodontics: * Root planing * Initial therapy * Treatment of periodontal pockets * Treatment of furcations * Maintenance therapy * Implant maintenance Endodontics: * Canal preparation * Canal cleaning * Canal filling * Gutta percha condensation * Treatment resumption * Retro Surgery * Micro Retro Surgery Scaling (prophylaxis): * Interdental…

Read the full statement (102 words)

Periodontics

Endodontics

Scaling

Prosthesis

Please refer to the attached listing for a detailed description.

Periodontics:

* Root planing

* Initial therapy

* Treatment of periodontal pockets

* Treatment of furcations

* Maintenance therapy

* Implant maintenance

Endodontics:

* Canal preparation

* Canal cleaning

* Canal filling

* Gutta percha condensation

* Treatment resumption

* Retro Surgery

* Micro Retro Surgery

Scaling (prophylaxis):

* Interdental junction treatment

* Tooth neck and subgingival treatment

* Treatment of large deposits

* Treatment of coating and tobacco stains

* Interproximal treatment

Prosthesis (conservative/restorative):

* Inlay/onlay condensation

* Amalgam plugging

* Loosening prostheses (bridge, crown, post, pivot...)

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060275 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060275: Piezotome.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060275

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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