510(k) Report

510(k) · Cleared

Cleared

Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor Int-D and Attachment Int-SNC

K070155510(k) TraditionalCleared Jan 25, 20078-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

Osseo Scientific, LLC · EFB Handpiece, Air-Powered, Dental

Cleared on Jan 25, 2007 as substantially equivalent to K944713 (A-Dec, Inc., 1995) and 5 other predicates after an 8-day review. Its family tree reaches back 4 generations to 1976. 1 later device descends from it.

Decided
Jan 25, 2007
Review
8 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
6

Its longest line of descent runs back 4 generations to K760929 (1976). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1995: 1 other ancestor1994: 2 other ancestors1978: 1 other ancestor2010: 1 descendant clearedK760929 · Accutorq II · Ritter Co. · 1976K021250 · MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS 2014 (Small Head) · Handpiece Unlimited · 2002K032234 · MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K, 6012K · Mk-Dent GmbH · 2003K051872 · MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light Power System, Models: LS2011 · Mk-Dent GmbH · 200519801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 1 descendant K051872 · MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light Power System, Models: LS2011 · Mk-Dent GmbH · 2005K032234 · MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS 6021K, 6011K, 6012K · Mk-Dent GmbH · 2003K021250 · MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard Head) & HS 2014 (Small Head) · Handpiece Unlimited · 2002K760929 · Accutorq II · Ritter Co. · 19760
  1. Root · 4 generations backK760929 Accutorq IIRitter Co. · 1976
  2. 3 generations backK021250 MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012…Handpiece Unlimited · 2002
  3. 2 generations backK032234 MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K…Mk-Dent GmbH · 2003
  4. 1 generation backK051872 MK-Dent Low Speed Handpieces and Accessories Including Spare Parts…Mk-Dent GmbH · 2005
  5. This deviceK070155 Integrity Low Speed Dental Air Handpiece and Attachment, Models…Osseo Scientific, LLC · 2007
  6. Descendant · cites it directly · 0 of its ownK093971 Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd. · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K093971Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K760929Accutorq IIRitter Co.1976—
−3K021250MK-Dent Push Button Highspeed Handpiece, 4 Holes, Models HS 2012 (Standard…Handpiece Unlimited2002—
−2K032234MK-Dent High Speed Dental Handpiece, Models HS 4021K, 4011K, 4012K, and HS…Mk-Dent GmbH2003—
−1K051872MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings…Mk-Dent GmbH2005—
0 (this device)K070155Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E…Osseo Scientific, LLC2007—
+1K093971Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
199420
199510
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K070155, 1976–2010Source: 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? (6)

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
*K944713W&H Micro Air Motor LT25
Summary page 2
…nd polishing teeth for use by a trained professional in general dentistry. 6. Predicate Device Name: For Model INT-E: A-dec/W&H Synea & TreND Low Speed (K944713 & K993526) and Dabi Atlante Low Speed (K926154). For Model INT-SNC: A-dec/W&H Synea & TreND ( K993526), Dabi Atlante (K926155) an…
A-Dec, Inc.1995—
*K993526Synea - LS Low-Speed Handpiece
Summary page 2
…ng teeth for use by a trained professional in general dentistry. 6. Predicate Device Name: For Model INT-E: A-dec/W&H Synea & TreND Low Speed (K944713 & K993526) and Dabi Atlante Low Speed (K926154). For Model INT-SNC: A-dec/W&H Synea & TreND ( K993526), Dabi Atlante (K926155) and MK-dent…
A-Dec, Inc.2000—
*K926154Handpiece Models: MS-350;RS-350;N-270 Air-Motor
Summary page 2
…ional in general dentistry. 6. Predicate Device Name: For Model INT-E: A-dec/W&H Synea & TreND Low Speed (K944713 & K993526) and Dabi Atlante Low Speed (K926154). For Model INT-SNC: A-dec/W&H Synea & TreND ( K993526), Dabi Atlante (K926155) and MK-dent Straight Handpiece (K051872) For Mod…
Dabi-Atlante America Corp.1994—
*K926155CA and ST
Summary page 2
…l INT-E: A-dec/W&H Synea & TreND Low Speed (K944713 & K993526) and Dabi Atlante Low Speed (K926154). For Model INT-SNC: A-dec/W&H Synea & TreND ( K993526), Dabi Atlante (K926155) and MK-dent Straight Handpiece (K051872) For Model INT-D: Promident Low Speed (K781545) 7. Description of Device: The Inte…
Dabi-Atlante America Corp.1994—
*K051872MK-Dent Low Speed Handpieces and Accessories Including Spare Parts, Tubings, and Light…
Summary page 2
…d (K944713 & K993526) and Dabi Atlante Low Speed (K926154). For Model INT-SNC: A-dec/W&H Synea & TreND ( K993526), Dabi Atlante (K926155) and MK-dent Straight Handpiece (K051872) For Model INT-D: Promident Low Speed (K781545) 7. Description of Device: The Integrity Low Speed Handpiece is a 5-vane mot…
Mk-Dent GmbH2005—
*K781545Air Powered Dental Handpiece
Summary page 2
…(K926154). For Model INT-SNC: A-dec/W&H Synea & TreND ( K993526), Dabi Atlante (K926155) and MK-dent Straight Handpiece (K051872) For Model INT-D: Promident Low Speed (K781545) 7. Description of Device: The Integrity Low Speed Handpiece is a 5-vane motor, ranging in speed up to 20,000 RPM, and is…
Promident Mfg., Ltd.1978—

Also cleared against K944713: 1 other device →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K093971Dental HandpieceNorth West Medical Instrument (Group) Co., Ltd.20100

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?

  • The line of descent spans 31 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K093971 (North West Medical Instrument (Group) Co., Ltd., 2010) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K944713.

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. 2007, 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?

The INTEGRITY Air Powered Low Speed Handpieces are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations, restorations and polishing teeth for use by a trained professional in general dentistry.

Indications for use as stated in the FDA summary.

Also cleared against K944713

1 other device cites the same predicate.

  • K091065Air Torx, Model Tra-200, Tra-200-CP3, Tra-200-CP4J. Morita USA, 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/K070155 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070155: Integrity Low Speed Dental Air Handpiece and Attachment, Models: Motor Int-E, Motor Int-D and Attachment Int-SNC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070155

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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