510(k) Report

510(k) · Cleared

Cleared

Atr 3000, Atr 2000, Implant-Pro

K991401510(k) TraditionalCleared Dec 15, 1999237-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

Advanced Technology Research (A.T.R.) S.R.P. · EFB Handpiece, Air-Powered, Dental

Cleared on Dec 15, 1999 as substantially equivalent to K911068 (Micro Motors, Inc., 1991) after a 237-day review. Its family tree reaches back 1 generation to 1991. 4 later devices descend from it.

Decided
Dec 15, 1999
Review
237 days
Class
Class I
Product code
EFB
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K911068 (1991). 4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2004: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant clearedK911068 · 29540 Dynasurg Electric Handpiece and Irr. System · Micro Motors, Inc. · 19911990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant K911068 · 29540 Dynasurg Electric Handpiece and Irr. System · Micro Motors, Inc. · 19910
  1. Root · 1 generation backK911068 29540 Dynasurg Electric Handpiece and Irr. SystemMicro Motors, Inc. · 1991
  2. This deviceK991401 Atr 3000, Atr 2000, Implant-ProAdvanced Technology Research (A.T.R.) S.R.P. · 1999
  3. Descendant · cites it directly · 3 of its ownK033597 Atr 5000, LC 5000, Implant SystemAdvanced Technology Research (A.T.R.) S.R.L. · 2003
  4. Descendant · 2 generations on · 1 of its ownK041279 Implanteo Implantology MotorAnthogyr · 2004
  5. Descendant · 3 generations on · 0 of its ownK102241 Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011
  6. Descendant · 2 generations on · 0 of its ownK091913 HI Tech Implant, HT Physio ImplantBy Dental Srl · 2009

Most influential descendants

Showing 4 of 4 · See all
  • K033597Atr 5000, LC 5000, Implant SystemAdvanced Technology Research (A.T.R.) S.R.L. · 2003 · cites it directly3descendants
  • K041279Implanteo Implantology MotorAnthogyr · 2004 · 2 generations on1descendant
  • K102241Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011 · 3 generations on0descendants
  • K091913HI Tech Implant, HT Physio ImplantBy Dental Srl · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K91106829540 Dynasurg Electric Handpiece and Irr. SystemMicro Motors, Inc.1991—
0 (this device)K991401Atr 3000, Atr 2000, Implant-ProAdvanced Technology Research (A.T.R.) S.R.P.1999—
+1K033597Atr 5000, LC 5000, Implant SystemAdvanced Technology Research (A.T.R.) S.R.L.2003—
+2K041279Implanteo Implantology MotorAnthogyr2004—
+3K102241Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas2011—
+2K091913HI Tech Implant, HT Physio ImplantBy Dental Srl2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200410
200910
201110
FIG. 1 — Lineage of K991401, 1991–2011Source: 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
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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
*K91106829540 Dynasurg Electric Handpiece and Irr. System
Summary page 1
…me: Dental Handpiece and Accessories 21 CFR 872.4200 IDENTIFICATION OF PREDICATE DEVICE Company Device 510(k) No. Date Cleared MicroMotors Dynasurg Electric Handpiece K911068 05/15/91 and Irrigation System DEVICE DESCRIPTION The ATR Surgical Micromotors are microprocessor driven surgical micromotors…
Micro Motors, Inc.1991—

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K033597Atr 5000, LC 5000, Implant SystemAdvanced Technology Research (A.T.R.) S.R.L.20033

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, K033597 (Advanced Technology Research (A.T.R.) S.R.L., 2003) has gone furthest, with 3 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?

The ATR Surgical Micromotors are intended to prepare intraoral bone for implantology procedures.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K991401: Atr 3000, Atr 2000, Implant-Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991401

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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