510(k) Report

510(k) · Cleared

Cleared

W-H Topair Dental Handpiece

K912786510(k) TraditionalCleared Jul 17, 199123-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

Sabra-The Dental Products Group · EFB Handpiece, Air-Powered, Dental

Cleared on Jul 17, 1991 after a 23-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 20 later devices descend from it.

Decided
Jul 17, 1991
Review
23 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
0

20 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1997: 2 descendants cleared2013: 1 descendant cleared2010: 1 descendant cleared2015: 2 descendants cleared2012: 1 descendant cleared2022: 1 descendant cleared2023: 3 descendants cleared2021: 1 descendant cleared2019: 1 descendant cleared2024: 2 descendants cleared2018: 1 descendant cleared2017: 1 descendant cleared2020: 2 descendants cleared2026: 1 descendant cleared1990200020102020
  1. This deviceK912786 W-H Topair Dental HandpieceSabra-The Dental Products Group · 1991
  2. Descendant · cites it directly · 18 of its ownK972376 Impact Air 45 Handpiece for Periodontal UseGlenwood, LLC · 1997
  3. Descendant · 2 generations on · 17 of its ownK101717 Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam…Aerobine, Inc. · 2010
  4. Descendant · 3 generations on · 16 of its ownK112024 TI-Max X450Nakanishi, Inc. · 2012
  5. Descendant · cites it directly · 10 of its ownK972375 Impact Air 45 Handpiece for Endodontic UseGlenwood, LLC · 1997
  6. Descendant · 2 generations on · 9 of its ownK130455 430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division · 2013

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

1997: 22010: 12012: 12013: 12015: 22017: 12018: 12019: 12020: 22021: 12022: 12023: 32024: 22026: 1
1997high 3 (2023) · low 0 (1998)2026

Most influential descendants

Showing 5 of 20 · See all
  • K972376Impact Air 45 Handpiece for Periodontal UseGlenwood, LLC · 1997 · cites it directly18descendants
  • K101717Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor 45; Karam 4H…Aerobine, Inc. · 2010 · 2 generations on17descendants
  • K112024TI-Max X450Nakanishi, Inc. · 2012 · 3 generations on16descendants
  • K972375Impact Air 45 Handpiece for Endodontic UseGlenwood, LLC · 1997 · cites it directly10descendants
  • K130455430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division · 2013 · 2 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K912786W-H Topair Dental HandpieceSabra-The Dental Products Group1991—
+1K972376Impact Air 45 Handpiece for Periodontal UseGlenwood, LLC1997—
+2K101717Dental Handpieces, Models: Karam STD/Mini; Breeze STD/Mini: Karam 45; Dexor…Aerobine, Inc.2010—
+3K112024TI-Max X450Nakanishi, Inc.2012—
+1K972375Impact Air 45 Handpiece for Endodontic UseGlenwood, LLC1997—
+2K130455430 SWL 45 and 430 SW 45 High-Speed HandpiecesDentalez Group, Stardental Division2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199720
201010
201210
201310
201520
201710
201810
201910
202020
202110
202210
202330
202420
202610
FIG. 1 — Lineage of K912786, 1991–2026Source: 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), 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K972376Impact Air 45 Handpiece for Periodontal UseGlenwood, LLC199718
K972375Impact Air 45 Handpiece for Endodontic UseGlenwood, LLC199710

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, K972376 (Glenwood, LLC, 1997) has gone furthest, with 18 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—

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/K912786 · printed Nov 5, 2026

Cite this page

510(k) Report. “K912786: W-H Topair Dental Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K912786

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026