510(k) Report

510(k) · Cleared

Cleared

Cavitron Prophy-Jet Air Polishing Prophylaxis System

K130862510(k) TraditionalCleared Jul 23, 2013117-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

Dentsply Intl., Inc. · ELC Scaler, Ultrasonic

Cleared on Jul 23, 2013 as substantially equivalent to K970342 (Dentsply Intl., 1997) and 3 other predicates after a 117-day review. Its family tree reaches back 5 generations to 1990.

Decided
Jul 23, 2013
Review
117 days
Class
Class II
Product code
ELC
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K900709 (1990). 20 ancestors in all, the oldest K864996 (1987). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2005: 2 other ancestors1997: 3 other ancestors2010: 2 other ancestors2009: 1 other ancestor2007: 1 other ancestor1987: 1 other ancestor2000: 1 other ancestor1995: 1 other ancestor1993: 1 other ancestor1990: 1 other ancestorK900709 · Air Flow Sii · Electro Medical Systems (Ems Sa) · 1990K991857 · Airflow Handy · Electro Medical Systems, Inc. · 1999K022119 · Ems Air-Flow Handy 2 Dental Handpiece · Electro Medical Systems SA · 2002K092289 · Ems Air-Flow Handy Perio · E.M.S Electro Medical Systems S.A · 2009K110173 · Ems Air-Flow Master Piezon · E.M.S Electro Medical Systems S.A · 20111985199019952000200520102015
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 6 other ancestors3 generations back: 1 other ancestor4 generations back: 2 other ancestors5 generations back: 3 other ancestors K110173 · Ems Air-Flow Master Piezon · E.M.S Electro Medical Systems S.A · 2011K092289 · Ems Air-Flow Handy Perio · E.M.S Electro Medical Systems S.A · 2009K022119 · Ems Air-Flow Handy 2 Dental Handpiece · Electro Medical Systems SA · 2002K991857 · Airflow Handy · Electro Medical Systems, Inc. · 1999K900709 · Air Flow Sii · Electro Medical Systems (Ems Sa) · 1990−50
  1. Root · 5 generations backK900709 Air Flow SiiElectro Medical Systems (Ems Sa) · 1990
  2. 4 generations backK991857 Airflow HandyElectro Medical Systems, Inc. · 1999
  3. 3 generations backK022119 Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA · 2002
  4. 2 generations backK092289 Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A · 2009
  5. 1 generation backK110173 Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A · 2011
  6. This deviceK130862 Cavitron Prophy-Jet Air Polishing Prophylaxis SystemDentsply Intl., Inc. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K900709Air Flow SiiElectro Medical Systems (Ems Sa)1990—
−4K991857Airflow HandyElectro Medical Systems, Inc.1999—
−3K022119Ems Air-Flow Handy 2 Dental HandpieceElectro Medical Systems SA2002—
−2K092289Ems Air-Flow Handy PerioE.M.S Electro Medical Systems S.A2009—
−1K110173Ems Air-Flow Master PiezonE.M.S Electro Medical Systems S.A2011—
0 (this device)K130862Cavitron Prophy-Jet Air Polishing Prophylaxis SystemDentsply Intl., Inc.2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198710
199010
199310
199510
199730
200010
200520
200710
200910
201020
201110
FIG. 1 — Lineage of K130862, 1990–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K260773 Varios Combi Pro2score 12.5 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K970342Cavitron Jet with SPS System
Summary page 1
…tially equivalent to the following legally marketed devices: * Dentsply International Cavitron® SPS Ultrasonic Scaler and Prophy-Jet®, K970342, product code ELC. * Dentsply International Cavitron® RF Ultrasonic Scaler with Sterimate Handpiece, K(…
Dentsply Intl.1997—
*K052334Cavitron RF Ultrasonic Scaler System with Sterimate Handpiece, Model G-131
Summary page 2
…the predicate devices; Cavitron®&SPS Ultrasonic Scaler and Prophy Jet (K970342) and Cavitron® RF Ultrasonic Scaler with Sterimate Handpicce (K0523 34). All devices operate by the use of a foot pedal. The foot pedal in the Cavitron®D Prophy-Jet® Air Polishing Prophy…
Dentsply Intl.2005—
*K110173Ems Air-Flow Master Piezon
Summary page 1
…ron® RF Ultrasonic Scaler with Sterimate Handpiece, K(052334, product code ELC. *EMS Electro Medical Systems, S.A. EMS Air-Flow Master Piezon, K1 10173, Product Codes ELC, EFB, EJR *Satelec Air-N-Go, Ki 10379, Product Code EFB The following ac…
E.M.S Electro Medical Systems S.A2011—
*K110379Air-N-GO
Summary page 3
…cleared indications for newer air polishing devices. Specifically, the Satelec: Mr-N-Go dental prophylaxis handpiece (cleared under premarket notification KI110379) and the EMS Medical Systems Air-Flow Master Piezon (cleared under premarket notification Kl110173) include indications for…
Satelec2011—

Also cleared against K970342: 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 23 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
  • None of the 20 ancestors has a recall.
  • 1 other device also cites its predicate K970342.

How does its category compare?

All ELC devices

ELC Scaler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · ELC

2in 2025

2007: 62008: 42009: 42010: 42011: 32012: 12013: 132014: 62015: 52016: 32017: 22018: 12019: 42020: 12021: 32022: 22023: 52024: 42025: 22026 (partial year): 2
2007high 13 (2013) · low 1 (2012)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ELC

104in 2024

2007: 92 days median2008: 216 days median2009: 121 days median2010: 201 days median2011: 122 days median2013: 174 days median2014: 193 days median2015: 150 days median2016: 88 days median2019: 192 days median2021: 196 days median2023: 258 days median2024: 104 days median
2007high 258 (2023) · low 88 (2016)2026

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

Recalls per year · ELC

2in 2022

2022: 2
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

2007: 122008: 582009: 1082010: 792011: 52012: 32013: 62014: 372015: 1352016: 1692017: 3562018: 2892019: 3022020: 1642021: 1662022: 1652023: 2102024: 2192025: 284
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007692012
20084216058
200941210108
20104201079
2011312205
20121—03
20131317406
20146193037
201551500135
20163880169
20172—0356
20181—0289
201941920302
20201—0164
202131960166
20222—2165
202352580210
202441040219
20252—0284
20262—0—

What is it indicated for?

The Cavitron Prophy-Jet Air Polishing Prophylaxis System is designed for use in general prophylaxis and periodontal treatments and other areas of operative dentistry. It can also be used for:

Stain removal,

Prophylaxis of orthodontic patients,

Preparing tooth surface prior to bonding and sealant procedures, and

Implant debridement

Indications for use as stated in the FDA summary.

Also cleared against K970342

1 other device cites the same predicate.

  • K014188New Prophy PowderDentsply Intl. · 2002

More from Dentsply Intl., Inc.

12 FDA decisions under this applicant name. See the company

  • K140347Ankylos C/X Implant SystemDentsply Intl., Inc. · 2014
  • K103244Qmix 2IN1 Endodontic Irrigating SolutionDentsply Intl., Inc. · 2011
  • K093221Pre-Cemented Orthodontic Bracket System Extension IIDentsply Intl., Inc. · 2009
  • K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
  • K082198Durashield PlusDentsply Intl., Inc. · 2008

Recent decisions in ELC

The ELC category page

  • K260773Varios Combi Pro2Nakanishi, Inc. · 2026
  • K253254GBT Machine Airflow Prophylaxis MasterE.M.S Electro Medical Systems S.A · 2026
  • K251689Varios 170 Lux Scaler System (VA170LUXS10); Varios 170 Lux Scaler System (VA170LUXS11); Varios 170 Scaler…Nakanishi, Inc. · 2025
  • K242317Integrated Endo System (Meet Endo-II)Denjoy Dental Co., Ltd. · 2025
  • K233844OdneCleanOdne AG · 2024

https://510kreport.com/device/K130862 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130862: Cavitron Prophy-Jet Air Polishing Prophylaxis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130862

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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