510(k) Report

510(k) · Cleared

Cleared

Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,

K022505510(k) TraditionalCleared Oct 1, 2003429-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

Nouvag AG · EGS Handpiece, Contra- And Right-Angle Attachment, Dental

Cleared on Oct 1, 2003 as substantially equivalent to K011061 (W&H Dentalwerk Buermoos GmbH, 2001) and 3 other predicates after a 429-day review. Its family tree reaches back 1 generation to 1996.

Decided
Oct 1, 2003
Review
429 days
Class
Class I
Product code
EGS
Recalls
None
Predicates
4

Its longest line of descent runs back 1 generation to K962540 (1996). 4 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2001: 1 other ancestor1999: 1 other ancestor1997: 1 other ancestorK962540 · E-Type Contra Angle Nac-E · Nsk Nakanishi, Inc. · 199619961998200020022004
Other ancestors, by generation 1 generation back: 3 other ancestors K962540 · E-Type Contra Angle Nac-E · Nsk Nakanishi, Inc. · 19960
  1. Root · 1 generation backK962540 E-Type Contra Angle Nac-ENsk Nakanishi, Inc. · 1996
  2. This deviceK022505 Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060…Nouvag AG · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K962540E-Type Contra Angle Nac-ENsk Nakanishi, Inc.1996—
0 (this device)K022505Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061…Nouvag AG2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
199910
200110
FIG. 1 — Lineage of K022505, 1996–2003Source: 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 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? (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
*K011061Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight…W&H Dentalwerk Buermoos GmbH2001—
*K984508Surgical Contra-Angle Handpieces, Models 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM and…
Summary page 2
…: W & H Dentalwerk Buermoos GmbH Device: Surgical Contra-Angel Handpiece Attachments 5 1O(k) : K984508 Date Cleared: June 25, 1999 Company: NSK, INC Device: E-T…
W&H Dentalwerk Buermoos GmbH1999—
*K962540E-Type Contra Angle Nac-E
Summary page 2
…ed: June 25, 1999 Company: NSK, INC Device: E-Type Contra-Angle 5 1O(k) : K962540 Date Cleared: September 12, 1996 Company: NSK, INC Device:…
Nsk Nakanishi, Inc.1996—
*K972569E-Type Speed Increaser Contra Angle, External Irrigation, Internal Irrigation
Summary page 2
…September 12, 1996 Company: NSK, INC Device: E-Type Speed Increaser Contra-Angle 5 1O(k) : K972 569 Date Cleared: October 08, 1997 Device Description: All mentioned NOUVAG Contra-Angle Attachments Dental ar…
Nsk Nakanishi, Inc.1997—

Also cleared against K011061: 9 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?

  • None of the 4 ancestors has a recall.
  • 9 other devices also cite its predicate K011061.

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?

Indications are widespread in the field of Surgery, Implantology and Endodontic treatment.

Surgery: 1059,5050,5051,5055,5056,5060,5062,5063,5065,5068,5070,5075

Endodontic treatment: 5057,5059,5061,5064,5066,5067,5069,5071,5076

Speed Increaser Contra-Angle: 5081

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, cuttin and/or finishing of dentures, denture bases, crowns, inlays and metal plates

All devices are driven by an electric micromotor handpiece that has the ISO-3964 Coupling.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K011061

9 other devices cite the same predicate.

  • K140308Mastersurg / ExpertsurgKaltenbach & Voigt GmbH · 2014
  • K121901TI-Max Z45Nakanishi, Inc. · 2013
  • K123695Traus SIP10Saeshin Precision Co., Ltd. · 2012
  • K112305Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low Speed Straight HandpiecesThunder Tiger Corp. · 2012
  • K111532Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas · 2011
  • K100192Strong Dental HandpiecesSaeshin Precision Co., Ltd. · 2010

More from Nouvag AG

12 FDA decisions under this applicant name. See the company

  • K254135LipoSurg ARTISTNouvag AG · 2026
  • K080365Morce Power Plus and Variocarve MorcellatorNouvag AG · 2009
  • K081191TCM Endo 20Nouvag AG · 2008
  • K071588Dispenser DP 20Nouvag AG · 2007
  • K042822TCM Endo V, Model 1534Nouvag AG · 2004

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/K022505 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022505: Contra-Angle, Models 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022505

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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