510(k) Report

510(k) · Cleared

Cleared

Anthogyr Impulsion Implantology Contra-Angle

K093894510(k) SpecialCleared Mar 3, 201075-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

Anthogyr · EFA Handpiece, Belt And/Or Gear Driven, Dental

Cleared on Mar 3, 2010 as substantially equivalent to K040674 (Anthogyr, 2004) after a 75-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.

Decided
Mar 3, 2010
Review
75 days
Class
Class I
Product code
EFA
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K971350 (1997). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2020: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant clearedK971350 · Series XE, Series SE, Series TE · Micro-Mega Societe Anonyme · 1997K040674 · Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles · Anthogyr · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K040674 · Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles · Anthogyr · 2004K971350 · Series XE, Series SE, Series TE · Micro-Mega Societe Anonyme · 19970
  1. Root · 2 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
  2. 1 generation backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
  3. This deviceK093894 Anthogyr Impulsion Implantology Contra-AngleAnthogyr · 2010
  4. Descendant · cites it directly · 2 of its ownK192809 Dental HandpieceMicro-Nx Co., Ltd. · 2020
  5. Descendant · 2 generations on · 1 of its ownK220577 Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022
  6. Descendant · 3 generations on · 0 of its ownK232810 Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023

Most influential descendants

Showing 3 of 3 · See all
  • K192809Dental HandpieceMicro-Nx Co., Ltd. · 2020 · cites it directly2descendants
  • K220577Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022 · 2 generations on1descendant
  • K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K971350Series XE, Series SE, Series TEMicro-Mega Societe Anonyme1997—
−1K040674Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra…Anthogyr2004—
0 (this device)K093894Anthogyr Impulsion Implantology Contra-AngleAnthogyr2010—
+1K192809Dental HandpieceMicro-Nx Co., Ltd.2020—
+2K220577Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd.2022—
+3K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202210
202310
FIG. 1 — Lineage of K093894, 1997–2023Source: 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 EFA? 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 EFA device

  1. #1 K192809 Dental Handpiecescore 3.5 · 3 generations · no Class I recall
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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
*K040674Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles
Summary page 1
…e.bravette.Drod~anthloovr.com Ti-dde Names ANTHOGYR * TImpuls ion wImplantology Contra-angles Legally marketed Ant hogyr Implantology Contra angles K040674 predicate devices Classification Name Dental handpiece and accessories Class I Product Code…
Anthogyr2004—

Also cleared against K040674: 4 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K192809Dental HandpieceMicro-Nx Co., Ltd.20202

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 13 years and passes through 2 companies; a new generation was cleared every 7.1 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K192809 (Micro-Nx Co., Ltd., 2020) has gone furthest, with 2 descendants of its own.
  • 4 other devices also cite its predicate K040674.

How does its category compare?

All EFA devices

EFA Handpiece, Belt And/Or Gear Driven, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · EFA

1in 2020

2007: 12009: 42010: 22015: 12017: 12020: 1
2007high 4 (2009) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EFA

78in 2009

2009: 78 days median
2007high 78 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · EFA

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EFA

4in 2025

2007: 12008: 172010: 12011: 42012: 12016: 12017: 22018: 972019: 592020: 22022: 42023: 32024: 52025: 4
2007high 97 (2018) · low 0 (2009)2025

MAUDE reports naming product code EFA, 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
20071—01
20080—017
200947800
20102—11
20110—04
20120—01
20130—00
20140—00
20151—00
20160—01
20171—02
20180—097
20190—059
20201—02
20210—00
20220—04
20230—03
20240—05
20250—04
20260—0—

What is it indicated for?

ANTHOGYR's fully autoclavable contra-angles Implantology « Impulsion » are devices intended for a wide range of dental procedures including:

Implant surgery such as perforating the bone, tapping and threading procedures

This range can be used with special accessories like depth stop.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K093894: Anthogyr Impulsion Implantology Contra-Angle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K093894

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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