510(k) Report

510(k) · Cleared

Cleared

E-Type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation

K972569510(k) TraditionalCleared Oct 8, 199790-day reviewClass I21 CFR 872.4200

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

Nsk Nakanishi, Inc. · EGS Handpiece, Contra- And Right-Angle Attachment, Dental

Cleared on Oct 8, 1997 after a 90-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.

Decided
Oct 8, 1997
Review
90 days
Class
Class I
Product code
EGS
Recalls
None
Predicates
0

7 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared2012: 1 descendant cleared2015: 1 descendant cleared2026: 2 descendants cleared2021: 1 descendant cleared1995200020052010201520202025
  1. This deviceK972569 E-Type Speed Increaser Contra Angle, External Irrigation, Internal…Nsk Nakanishi, Inc. · 1997
  2. Descendant · cites it directly · 4 of its ownK112305 Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle…Thunder Tiger Corp. · 2012
  3. Descendant · 2 generations on · 3 of its ownK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
  4. Descendant · 3 generations on · 0 of its ownK262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
  5. Descendant · 3 generations on · 0 of its ownK251388 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4…Foshan Topmed Dental Co., Ltd. · 2026
  6. Descendant · 3 generations on · 0 of its ownK202786 Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc. · 2021

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2003: 22012: 12015: 12021: 12026: 2
2003high 2 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 7 · See all
  • K112305Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low…Thunder Tiger Corp. · 2012 · cites it directly4descendants
  • K141886MDK HandpiecesModern Korea Co., Ltd. · 2015 · 2 generations on3descendants
  • K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026 · 3 generations on0descendants
  • K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd. · 2026 · 3 generations on0descendants
  • K202786Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K972569E-Type Speed Increaser Contra Angle, External Irrigation, Internal IrrigationNsk Nakanishi, Inc.1997—
+1K112305Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor…Thunder Tiger Corp.2012—
+2K141886MDK HandpiecesModern Korea Co., Ltd.2015—
+3K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd.2026—
+3K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS…Foshan Topmed Dental Co., Ltd.2026—
+3K202786Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc.2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
201210
201510
202110
202620
FIG. 1 — Lineage of K972569, 1997–2026Source: 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EGS? 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 EGS device

  1. #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (7)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K112305Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low…Thunder Tiger Corp.20124
K022505Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063…Nouvag AG20030
K031540Apex Electric Handpiece SystemLares Research, Inc.20030

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, K112305 (Thunder Tiger Corp., 2012) has gone furthest, with 4 descendants of its own.

How does its category compare?

All EGS devices

EGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EGS

2in 2025

2007: 12009: 12010: 22011: 32012: 32013: 12014: 22015: 32017: 22018: 12019: 32020: 12021: 12022: 42023: 12024: 12025: 2
2007high 4 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EGS

189in 2022

2011: 104 days median2012: 288 days median2015: 245 days median2019: 276 days median2022: 189 days median
2007high 288 (2012) · low 104 (2011)2026

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

Recalls per year · EGS

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

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

Adverse event reports per year · EGS

82in 2025

2007: 22008: 142009: 452010: 742011: 22012: 32013: 22014: 382015: 1662016: 2992017: 3162018: 2302019: 2192020: 1912021: 2942022: 2792023: 1152024: 812025: 82
2007high 316 (2017) · low 2 (2007)2025

MAUDE reports naming product code EGS, 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
20071—02
20080—014
20091—045
20102—074
2011310402
2012328803
20131—02
20142—038
201532450166
20160—0299
20172—0316
20181—0230
201932760219
20201—0191
20211—0294
202241890279
20231—1115
20241—081
20252—082
20260—0—

What is it indicated for?

The device is intended for use where high speed such as 200,000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cutting and/or finishing of dentures, denture bases, crowns, inlays and metal plates.

The device is driven by an electric micromotor or an air motor handpiece that has the I1S0-3964 Coupling.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Nsk Nakanishi, Inc.

13 FDA decisions under this applicant name. See the company

  • K991701Mach-Sigma Handpiece, Ultrapush, Models Mach-Sigma MU (Mini Head), Mach-Sigma SU (STD. Head), Mach-Sigma TU…Nsk Nakanishi, Inc. · 1999
  • K991021Sonic Scaler with Fiber Optic, Model Nas-L, Sonic Scaler Without Fiber Optic, Model Nas-NLNsk Nakanishi, Inc. · 1999
  • K990954Elec-Mate, Models EX-6 Set, EX-6L Set, EX-30 SetNsk Nakanishi, Inc. · 1999
  • K990682Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.)Nsk Nakanishi, Inc. · 1999
  • K990646Portable Electric Motor-Handpiece Unit, Handy-MateNsk Nakanishi, Inc. · 1999

Recent decisions in EGS

The EGS category page

  • K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) Limited · 2025
  • K240950Disposable Prophy AnglePacific Care Limited · 2025
  • K240183Star E900 Handpiece SeriesDentalez, Inc., Stardental Division · 2024
  • K230106General Cutting StraightNakanishi, Inc. · 2023
  • K222518FX ContraNakanishi, Inc. · 2022

https://510kreport.com/device/K972569 · printed Nov 4, 2026

Cite this page

510(k) Report. “K972569: E-Type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972569

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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