510(k) Report

510(k) · Cleared

Cleared

ND Lowspeed Airmotor,ND Highspeed Airturbine Handpiece

K113222510(k) TraditionalCleared Feb 23, 2012114-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

Nakamura Dental Handpiece Mfg. Co., Ltd. · EFB Handpiece, Air-Powered, Dental

Cleared on Feb 23, 2012 after a 114-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Feb 23, 2012
Review
114 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K113222Source: FDA 510(k) database · 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 EFB? 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 EFB device

  1. #1 K262144 DIAMED Handpiece;DIAMED Airmotor;DIAMED…score 13.3 · 5 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

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

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.

How does its category compare?

All EFB devices

EFB Handpiece, Air-Powered, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · EFB

1in 2025

2007: 122008: 72009: 112010: 82011: 42012: 82013: 32014: 72015: 72016: 32017: 72018: 32019: 32020: 52021: 22022: 52023: 42024: 52025: 12026 (partial year): 4
2007high 12 (2007) · low 1 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFB

209in 2024

2007: 61 days median2008: 97 days median2009: 120 days median2010: 116 days median2011: 168 days median2012: 130 days median2013: 207 days median2014: 200 days median2015: 296 days median2016: 205 days median2017: 246 days median2018: 210 days median2019: 348 days median2020: 259 days median2022: 430 days median2023: 158 days median2024: 209 days median2026 (partial year): 252 days median
2007high 430 (2022) · low 61 (2007)2026

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

Recalls per year · EFB

No recall names EFB since 2007.

Adverse event reports per year · EFB

83in 2025

2007: 132008: 192009: 402010: 782011: 962012: 972013: 612014: 732015: 872016: 1222017: 1532018: 812019: 1172020: 942021: 1232022: 1572023: 1162024: 1042025: 83
2007high 157 (2022) · low 13 (2007)2025

MAUDE reports naming product code EFB, 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
20071261013
2008797019
200911120040
20108116078
20114168096
20128130097
20133207061
20147200073
20157296087
201632050122
201772460153
20183210081
201933480117
20205259094
20212—0123
202254300157
202341580116
202452090104
20251—083
202642520—

What is it indicated for?

ND Iowspeed airmotor, MP-50M, is used to power prophy angle attachment that helps dental clinician perform the hygiene dentistry work such as cleaning. The device is autoclavable. ND low speed airmotor, MS-1GOM / MS-55M, are used to power attachment that helps dental clinician perform various dental work such as cleaning, tooth carving, others. The device is autoclavable. ND star-type straight nosecone attachment, STS-30H, is powered by either Iowspeed…

Read the full statement (186 words)

ND Iowspeed airmotor, MP-50M, is used to power prophy angle attachment that helps dental clinician perform the hygiene dentistry work such as cleaning. The device is autoclavable.

ND low speed airmotor, MS-1GOM / MS-55M, are used to power attachment that helps dental clinician perform various dental work such as cleaning, tooth carving, others. The device is autoclavable.

ND star-type straight nosecone attachment, STS-30H, is powered by either Iowspeed airmotor or electric micromotor for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable.

ND star-type contra angle attachment, STC-20L / STU-20ML / STU-35BL / STU-3OBLP, are powered by either Iowspeed airmotor or electric micromotor for removing carlous material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restorations and polishing teeth. The device is autoclavable

ND highspeed airturbine handpiece. TCP-700M I TCP-7008 / TC-80QM / TC-BOQB, are air-powered dental handpiece for removing carious material and excess filling material, cavity and crown preparation, root canal preparations, finishing tooth preparations, restoration and polishing teet The device is autoclavable.

Indications for use as stated in the FDA 510(k) statement.

Recent decisions in EFB

The EFB category page

  • K260029Firstar Dental HandpiecesFDC Technology Industry Co. · 2026
  • K262144DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor HandpieceSETAGAYA SEIKI Co., Ltd. · 2026
  • K251389High speed air turbine handpieceFoshan Topmed Dental Co., Ltd. · 2026
  • K251388Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB…Foshan Topmed Dental Co., Ltd. · 2026
  • K242179Synea Fusion Handpieces (Intensiv & Profin)W&H Dentalwerk Bürmoos GmbH · 2025

https://510kreport.com/device/K113222 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113222: ND Lowspeed Airmotor,ND Highspeed Airturbine Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113222

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026