510(k) · Cleared
ClearedAnthogyr Impulsion Implantology Contra-Angle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 2 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 1 generation backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- This deviceK093894 Anthogyr Impulsion Implantology Contra-AngleAnthogyr · 2010
- Descendant · cites it directly · 2 of its ownK192809 Dental HandpieceMicro-Nx Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK220577 Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022
- 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −1 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| 0 (this device) | K093894 | Anthogyr Impulsion Implantology Contra-Angle | Anthogyr | 2010 | — |
| +1 | K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020 | — |
| +2 | K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022 | — |
| +3 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
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 K192809 Dental Handpiecescore 3.5 · 3 generations · no Class I recall
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra AnglesSummary 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… | 2004 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192809 | Dental Handpiece | 2020 | 2 |
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 devicesEFA 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
2026 to Oct 25, outlined.
Median 510(k) review, days · EFA
78in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EFA
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EFA
4in 2025
MAUDE reports naming product code EFA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 4 | 78 | 0 | 0 |
| 2010 | 2 | — | 1 | 1 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 97 |
| 2019 | 0 | — | 0 | 59 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 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.
https://510kreport.com/device/K093894 · printed Nov 5, 2026
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