510(k) Report

510(k) · Cleared

Cleared

Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight Nosecones

K083101510(k) AbbreviatedCleared Feb 23, 2009126-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

Sable Industries, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Feb 23, 2009 as substantially equivalent to K983183 (Bien Air USA, Inc., 1998) after a 126-day review. Its family tree reaches back 1 generation to 1998. 7 later devices descend from it.

Decided
Feb 23, 2009
Review
126 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K983183 (1998). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2015: 1 descendant cleared2026: 1 descendant cleared2017: 1 descendant cleared2020: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant clearedK983183 · Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P · Bien Air USA, Inc. · 19981995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 1 descendant5 generations forward: 1 descendant6 generations forward: 1 descendant K983183 · Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch, Isolite, Optima, US, Plpe, CA, P · Bien Air USA, Inc. · 19980+5
  1. Root · 1 generation backK983183 Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora…Bien Air USA, Inc. · 1998
  2. This deviceK083101 Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight…Sable Industries, Inc. · 2009
  3. Descendant · cites it directly · 6 of its ownK133069 Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2014
  4. Descendant · 2 generations on · 5 of its ownK150798 Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015
  5. Descendant · 3 generations on · 4 of its ownK170236 Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017
  6. Descendant · 4 generations on · 2 of its ownK181691 High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020
  7. Descendant · 5 generations on · 1 of its ownK220179 High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle…Foshan Coxo Medical Instrument Co., Ltd. · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2014: 12015: 12017: 12020: 12023: 12024: 12026: 1
2014high 1 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 7 · See all
  • K133069Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2014 · cites it directly6descendants
  • K150798Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd. · 2015 · 2 generations on5descendants
  • K170236Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd. · 2017 · 3 generations on4descendants
  • K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd. · 2020 · 4 generations on2descendants
  • K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air MotorsFoshan Coxo Medical Instrument Co., Ltd. · 2023 · 5 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983183Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon…Bien Air USA, Inc.1998—
0 (this device)K083101Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight NoseconesSable Industries, Inc.2009—
+1K133069Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd.2014—
+2K150798Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd.2015—
+3K170236Dental Low-speed Turbine HandpieceGuangdong Jinme Medical Technology Co., Ltd.2017—
+4K181691High-speed air turbine handpiece / Low-speed air turbine handpieceFoshan Wenjian Medical Instrument Co., Ltd.2020—
+5K220179High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle…Foshan Coxo Medical Instrument Co., Ltd.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201510
201710
202010
202310
202410
202610
FIG. 1 — Lineage of K083101, 1998–2026Source: 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 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
*K983183Gyro Long-Life,Black Pearl Eco, Ondine &Croma, Prestige, Bora, Aquilon, MC2,MC3, Basch…
Summary page 2
…Internal Air & Water (p/n&1610299) (pn 1610299)Angle Water Handpieces (K983183) Premium Slow Speed Contra-Angles Bien Air Straight and Contra- 1:1 Ball Bearing w/ Intern…
Bien Air USA, Inc.1998—

Also cleared against K983183: 3 other devices →

What descends from it? (7)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K133069Codent Low Speed Dental Handpieces and AccessoriesCodent Technical Industry Co., Ltd.20146

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, K133069 (Codent Technical Industry Co., Ltd., 2014) has gone furthest, with 6 descendants of its own.
  • 3 other devices also cite its predicate K983183.

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. 2009, 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?

Sable Industries Premium Slow Speed Dental Handpieces & Accessories are indicated for use in general dentistry for cleaning and polishing of teeth.

Indications for use as stated in the FDA summary.

Also cleared against K983183

3 other devices cite the same predicate.

  • K220874Smooth Drive contra angle and straight handpiecesLares Research · 2022
  • K072554Access and Rotamax Fiber Optic High Speed Dental HandpiecesSable Industries, Inc. · 2007
  • K031145Estylus Electric Motor SystemDentsply Intl. · 2003

More from Sable Industries, Inc.

2 FDA decisions under this applicant name. See the company

  • K072554Access and Rotamax Fiber Optic High Speed Dental HandpiecesSable Industries, Inc. · 2007

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/K083101 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083101: Premium Slow Speed; 20K Air Motor, Heads, Contra-Angles, Straight Nosecones.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083101

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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