510(k) · Cleared
ClearedVigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low Speed Straight Handpieces
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thunder Tiger Corp. · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Apr 17, 2012 as substantially equivalent to K962540 (Nsk Nakanishi, Inc., 1996) and 5 other predicates after a 250-day review. Its family tree reaches back 1 generation to 1995. 4 later devices descend from it.
- Decided
- Apr 17, 2012
- Review
- 250 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 1 generation to K944711 (1995). 6 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK944711 W&H Air Motor A25A-Dec, Inc. · 1995
- This deviceK112305 Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle…Thunder Tiger Corp. · 2012
- Descendant · cites it directly · 3 of its ownK141886 MDK HandpiecesModern Korea Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251388 Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4…Foshan Topmed Dental Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK202786 Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc. · 2021
Most influential descendants
Showing 4 of 4 · See all- K141886MDK HandpiecesModern Korea Co., Ltd. · 2015 · cites it directly3descendants
- K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026 · 2 generations on0descendants
- K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES…Foshan Topmed Dental Co., Ltd. · 2026 · 2 generations on0descendants
- K202786Dental Low-speed Handpieces and AccessoriesMicrop Technology (Taiwan), Inc. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K944711 | W&H Air Motor A25 | A-Dec, Inc. | 1995 | — |
| 0 (this device) | K112305 | Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor… | Thunder Tiger Corp. | 2012 | — |
| +1 | K141886 | MDK Handpieces | Modern Korea Co., Ltd. | 2015 | — |
| +2 | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | 2026 | — |
| +2 | K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS… | Foshan Topmed Dental Co., Ltd. | 2026 | — |
| +2 | K202786 | Dental Low-speed Handpieces and Accessories | Microp Technology (Taiwan), Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 2026 | 2 | 0 |
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 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 | Decided |
|---|---|---|---|
| * | K962540 | E-Type Contra Angle Nac-ESummary page 1…Handpiece, contra- and fight-angle attachment, dental (21 CFR 872.4200, Product Code EGS) 4. Predicate Device: B-TYPE CONTRA ANGLE NAC-E, (K962540) Surgical Contra-Angel Hanpieces Type WS-56E, WE-75E/KM, WS-92 (K011061)… | 1996 |
| * | K011061 | Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight…Summary page 1…S) 4. Predicate Device: B-TYPE CONTRA ANGLE NAC-E, (K962540) Surgical Contra-Angel Hanpieces Type WS-56E, WE-75E/KM, WS-92 (K011061) ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET (K990954)… | 2001 |
| * | K990954 | Elec-Mate, Models EX-6 Set, EX-6L Set, EX-30 SetSummary page 1…Hanpieces Type WS-56E, WE-75E/KM, WS-92 (K011061) ELEC-MATE, MODELS EX-6 SET, EX-6L SET, EX-30 SET (K990954) E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION (K97… | 1999 |
| * | K972569 | E-Type Speed Increaser Contra Angle, External Irrigation, Internal IrrigationSummary page 1…, EX-30 SET (K990954) E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION (K972569) W&H AIR MOTOR A25 (K94471 1) ATHENA CONTRA ANGLE (K974670) 5. Device Description:… | 1997 |
| * | K944711 | W&H Air Motor A25Summary page 1…E-TYPE SPEED INCREASER CONTRA ANGLE, EXTERNAL IRRIGATION, INTERNAL IRRIGATION (K972569) W&H AIR MOTOR A25 (K94471 1) ATHENA CONTRA ANGLE (K974670) 5. Device Description: The Vigor Series Low speed dental handpiece… | 1995 |
| * | K974670 | Athena 1:1 Contra Angle, Athena 4:1 Contra Angle, Athena 16:1 Contra Angle, Athena 64:1…Summary page 1…EXTERNAL IRRIGATION, INTERNAL IRRIGATION (K972569) W&H AIR MOTOR A25 (K94471 1) ATHENA CONTRA ANGLE (K974670) 5. Device Description: The Vigor Series Low speed dental handpieces & Accessories are similar to other low-speed de… | 1998 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141886 | MDK Handpieces | 2015 | 3 |
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?
How does its category compare?
All EGS devicesEGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · EGS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGS
189in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGS
82in 2025
MAUDE reports naming product code EGS, 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 | 1 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 1 | — | 0 | 45 |
| 2010 | 2 | — | 0 | 74 |
| 2011 | 3 | 104 | 0 | 2 |
| 2012 | 3 | 288 | 0 | 3 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 38 |
| 2015 | 3 | 245 | 0 | 166 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 2 | — | 0 | 316 |
| 2018 | 1 | — | 0 | 230 |
| 2019 | 3 | 276 | 0 | 219 |
| 2020 | 1 | — | 0 | 191 |
| 2021 | 1 | — | 0 | 294 |
| 2022 | 4 | 189 | 0 | 279 |
| 2023 | 1 | — | 1 | 115 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 82 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Vigor Series Low speed dental handpieces & Accessories are powered by either low speed air motor or electric micro-motor for teeth cutting, cavity and crown preparation, restorations and polishing teeth. The Vigor A Low Speed Air Motor is used in conjunction with accessories such as contra-angle, such as The Vigor C Low Speed Contra-Angle handpieces, and straight handpiece, such as The Vigor S Low Speed Straight handpieces. The motor contains chip…
Read the full statement (128 words)
The Vigor Series Low speed dental handpieces & Accessories are powered by either low speed air motor or electric micro-motor for teeth cutting, cavity and crown preparation, restorations and polishing teeth. The Vigor A Low Speed Air Motor is used in conjunction with accessories such as contra-angle, such as The Vigor C Low Speed Contra-Angle handpieces, and straight handpiece, such as The Vigor S Low Speed Straight handpieces. The motor contains chip air and water that help with removing debris from teeth cutting. The Low Speed Contra Angle Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. The Straight Handpiece contains chip air and water that help with removing debris from teeth cutting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112305: Vigor a Low Speed Air Motor, Vigor C Low Speed Contra-Angle Handpieces, Vigor S Low Speed Straight Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112305
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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