510(k) Report

510(k) · Cleared

Cleared

Synea - LS Low-Speed Handpiece

K993526510(k) TraditionalCleared Jan 11, 200085-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

A-Dec, Inc. · EFB Handpiece, Air-Powered, Dental

Cleared on Jan 11, 2000 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.

Decided
Jan 11, 2000
Review
85 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
0

6 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2003: 1 descendant cleared2007: 1 descendant cleared2006: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared200020052010201520202025
  1. This deviceK993526 Synea - LS Low-Speed HandpieceA-Dec, Inc. · 2000
  2. Descendant · cites it directly · 2 of its ownK051872 MK-Dent Low Speed Handpieces and Accessories Including Spare Parts…Mk-Dent GmbH · 2005
  3. Descendant · cites it directly · 1 of its ownK070155 Integrity Low Speed Dental Air Handpiece and Attachment, Models…Osseo Scientific, LLC · 2007
  4. Descendant · cites it directly · 1 of its ownK053368 Interproximal Reduction SystemDentsply International · 2006
  5. Descendant · 2 generations on · 0 of its ownK093971 Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd. · 2010
  6. Descendant · 2 generations on · 0 of its ownK090548 Contra-Angle Handpiece Komet OS30W&H Dentalwerk Buermoos GmbH · 2009

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2003: 12005: 12006: 12007: 12009: 12010: 1
2003high 1 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 6 · See all
  • K051872MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light…Mk-Dent GmbH · 2005 · cites it directly2descendants
  • K070155Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor…Osseo Scientific, LLC · 2007 · cites it directly1descendant
  • K053368Interproximal Reduction SystemDentsply International · 2006 · cites it directly1descendant
  • K093971Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd. · 2010 · 2 generations on0descendants
  • K090548Contra-Angle Handpiece Komet OS30W&H Dentalwerk Buermoos GmbH · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K993526Synea - LS Low-Speed HandpieceA-Dec, Inc.2000—
+1K051872MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings…Mk-Dent GmbH2005—
+1K070155Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E…Osseo Scientific, LLC2007—
+1K053368Interproximal Reduction SystemDentsply International2006—
+2K093971Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd.2010—
+2K090548Contra-Angle Handpiece Komet OS30W&H Dentalwerk Buermoos GmbH2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200510
200610
200710
200910
201010
FIG. 1 — Lineage of K993526, 2000–2010Source: 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 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
Get a 510(k) Report

What was it cleared against?

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

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K051872MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light…Mk-Dent GmbH20052
K070155Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor…Osseo Scientific, LLC20071
K053368Interproximal Reduction SystemDentsply International20061
K031540Apex Electric Handpiece SystemLares Research, Inc.20030

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?

  • Of its descendants, K051872 (Mk-Dent GmbH, 2005) has gone furthest, with 2 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?

A dental low-speed handpiece is designed for removing carious material, cavity

and crown preparation, excess filling material, root canal preparations,

finishing tooth preparations, restorations and polishing teeth.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from A-Dec, Inc.

69 FDA decisions under this applicant name. See the company

  • K213932A-dec 300, A-dec 500A-Dec, Inc. · 2022
  • K133776A-Dec/W&H Electric Handpiece MotorA-Dec, Inc. · 2014
  • K102234A-Dec 200 Dental SystemA-Dec, Inc. · 2010
  • K100647A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMA-Dec, Inc. · 2010
  • K082716A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, a-Dec/W&H Alegra Handpiece Attachment…A-Dec, Inc. · 2009

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/K993526 · printed Nov 6, 2026

Cite this page

510(k) Report. “K993526: Synea - LS Low-Speed Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993526

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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