510(k) Report

510(k) · Cleared

Cleared

Codent Dental Air-Powered Handpiece, Model HPS

K033213510(k) TraditionalCleared Feb 6, 2004126-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

Codent Technical Industry Co., Ltd. · EFB Handpiece, Air-Powered, Dental

Cleared on Feb 6, 2004 as substantially equivalent to K935676 (Micro Motors, Inc., 1995) after a 126-day review. Its family tree reaches back 1 generation to 1995. 36 later devices descend from it.

Decided
Feb 6, 2004
Review
126 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K935676 (1995). 36 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2006: 4 descendants cleared2015: 3 descendants cleared2014: 2 descendants cleared2010: 3 descendants cleared2011: 2 descendants cleared2024: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2020: 2 descendants cleared2009: 1 descendant cleared2008: 1 descendant cleared2007: 1 descendant cleared2026: 3 descendants cleared2012: 2 descendants cleared2021: 2 descendants cleared2023: 3 descendants cleared2013: 1 descendant cleared2022: 1 descendant cleared2019: 1 descendant clearedK935676 · Micro RSH High Speed Handpiece · Micro Motors, Inc. · 19951995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 10 descendants3 generations forward: 8 descendants4 generations forward: 8 descendants5 generations forward: 7 descendants6 generations forward: 1 descendant K935676 · Micro RSH High Speed Handpiece · Micro Motors, Inc. · 19950+5
  1. Root · 1 generation backK935676 Micro RSH High Speed HandpieceMicro Motors, Inc. · 1995
  2. This deviceK033213 Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd. · 2004
  3. Descendant · cites it directly · 35 of its ownK052822 Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006
  4. Descendant · 2 generations on · 21 of its ownK062740 Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006
  5. Descendant · 2 generations on · 20 of its ownK062812 Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B…Thunder Tiger Corp. · 2006
  6. Descendant · 3 generations on · 17 of its ownK101717 Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam…Aerobine, Inc. · 2010
  7. Descendant · 4 generations on · 16 of its ownK112024 TI-Max X450Nakanishi, Inc. · 2012

Showing 5 of 36 descendants. See all descendants

Descendants cleared per year

2006: 42007: 12008: 12009: 12010: 32011: 22012: 22013: 12014: 22015: 32017: 12018: 12019: 12020: 22021: 22022: 12023: 32024: 22026: 3
2006high 4 (2006) · low 0 (2016)2026

Most influential descendants

Showing 5 of 36 · See all
  • K052822Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp. · 2006 · cites it directly35descendants
  • K062740Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd. · 2006 · 2 generations on21descendants
  • K062812Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300NThunder Tiger Corp. · 2006 · 2 generations on20descendants
  • K101717Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H…Aerobine, Inc. · 2010 · 3 generations on17descendants
  • K112024TI-Max X450Nakanishi, Inc. · 2012 · 4 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K935676Micro RSH High Speed HandpieceMicro Motors, Inc.1995—
0 (this device)K033213Codent Dental Air-Powered Handpiece, Model HPSCodent Technical Industry Co., Ltd.2004—
+1K052822Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp.2006—
+2K062740Jindell High Spped Air Turbine Handpiece, Models SW, SP, SU, Etu, MUJindell Medical Instruments Co., Ltd.2006—
+2K062812Dental Air-Powered Handpiece, Models Tiger 300T, 300K, 300W, 300B and 300NThunder Tiger Corp.2006—
+3K101717Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor…Aerobine, Inc.2010—
+4K112024TI-Max X450Nakanishi, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200640
200710
200810
200910
201030
201120
201220
201310
201420
201530
201710
201810
201910
202020
202120
202210
202330
202420
202630
FIG. 1 — Lineage of K033213, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 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
Get a 510(k) Report

What was it cleared against? (1)

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
*K935676Micro RSH High Speed Handpiece
Summary page 1
…code: EFB Panel: 72 Predicate Device: MICIO MOTORS RSH High Speed Handpiece 510/K No - K935676 Statement of Intended Use: The CODENfT Dental A ir- Powered Handpiece is intei ded for r…
Micro Motors, Inc.1995—

What descends from it? (36)

See all 36

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

NumberDeviceApplicantDecidedDescendants
K052822Dental Air-Powered Handpiece, Models Tiger 100, 101, 200, 201 and 202Thunder Tiger Corp.200635
K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd.20158

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?

  • Its one ancestor has no recall.
  • Of its descendants, K052822 (Thunder Tiger Corp., 2006) has gone furthest, with 35 descendants of its own.

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.

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?

CODENT Dental Air-Powered Handpiece, model HPS is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.

CODENT Dental Air-Powered Handpiece carries the following label: CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Indications for use as stated in the FDA summary.

More from Codent Technical Industry Co., Ltd.

5 FDA decisions under this applicant name. See the company

  • K231864Fiber Optic Brushless Electronic Micromotor, model: iM100Codent Technical Industry Co., Ltd. · 2024
  • K152146High Speed Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
  • K150798Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
  • K133069Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2014

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/K033213 · printed Nov 6, 2026

Cite this page

510(k) Report. “K033213: Codent Dental Air-Powered Handpiece, Model HPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033213

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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