510(k) Report

510(k) · Cleared

Cleared

Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles

K040674510(k) TraditionalCleared Jun 30, 2004107-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 Jun 30, 2004 as substantially equivalent to K020137 (Aseptico, Inc., 2002) and 1 other predicate after a 107-day review. Its family tree reaches back 1 generation to 1997. 26 later devices descend from it.

Decided
Jun 30, 2004
Review
107 days
Class
Class I
Product code
EFA
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K971350 (1997). 2 ancestors in all. 26 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2007: 1 descendant cleared2006: 1 descendant cleared2011: 3 descendants cleared2009: 2 descendants cleared2010: 2 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2017: 1 descendant cleared2015: 2 descendants cleared2022: 4 descendants cleared2014: 1 descendant cleared2019: 1 descendant cleared2016: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared2024: 1 descendant cleared2025: 2 descendants clearedK971350 · Series XE, Series SE, Series TE · Micro-Mega Societe Anonyme · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 6 descendants3 generations forward: 7 descendants4 generations forward: 3 descendants5 generations forward: 1 descendant6 generations forward: 3 descendants7 generations forward: 1 descendant K971350 · Series XE, Series SE, Series TE · Micro-Mega Societe Anonyme · 19970+5
  1. Root · 1 generation backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
  2. This deviceK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
  3. Descendant · cites it directly · 15 of its ownK092412 Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009
  4. Descendant · 2 generations on · 10 of its ownK111616 E-CUBESaeshin Precision Co., Ltd. · 2011
  5. Descendant · 3 generations on · 6 of its ownK133298 Endo SmartMeta Biomed, Inc. · 2014
  6. Descendant · 4 generations on · 5 of its ownK153285 EMS-200Meta Systems Co., Ltd. · 2016
  7. Descendant · cites it directly · 5 of its ownK060317 Anthogyr Contra Angles and HandpiecesEst. Anthogyr · 2006

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2006: 12007: 12009: 22010: 22011: 32014: 12015: 22016: 12017: 12018: 12019: 12020: 12021: 12022: 42023: 12024: 12025: 2
2006high 4 (2022) · low 0 (2008)2026

Most influential descendants

Showing 5 of 26 · See all
  • K092412Strong Implant HandpiecesSaeshin Precision Co., Ltd. · 2009 · cites it directly15descendants
  • K111616E-CUBESaeshin Precision Co., Ltd. · 2011 · 2 generations on10descendants
  • K133298Endo SmartMeta Biomed, Inc. · 2014 · 3 generations on6descendants
  • K153285EMS-200Meta Systems Co., Ltd. · 2016 · 4 generations on5descendants
  • K060317Anthogyr Contra Angles and HandpiecesEst. Anthogyr · 2006 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K971350Series XE, Series SE, Series TEMicro-Mega Societe Anonyme1997—
0 (this device)K040674Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra…Anthogyr2004—
+1K092412Strong Implant HandpiecesSaeshin Precision Co., Ltd.2009—
+2K111616E-CUBESaeshin Precision Co., Ltd.2011—
+3K133298Endo SmartMeta Biomed, Inc.2014—
+4K153285EMS-200Meta Systems Co., Ltd.2016—
+1K060317Anthogyr Contra Angles and HandpiecesEst. Anthogyr2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200710
200920
201020
201130
201410
201520
201610
201710
201810
201910
202010
202110
202240
202310
202410
202520
FIG. 1 — Lineage of K040674, 1997–2025Source: 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
Get a 510(k) Report

What was it cleared against? (2)

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
*K020137Ahp-66 4:1 Reduction Contrangle: Ahp-88 8:1 Reduction Contrangle: Ahp-88MP 8:1 Reduction…
Summary page 1
…dodontic Contra angles) 3. General dentistry Contra angles Legally marketed 1. Aseptico Autoclavable Handpieces (Aseptico) K020137 predicate devices 2. Aseptico Autoclavable Handpieces (Aseptico) K020137 3. Aseptic…
Aseptico, Inc.2002—
*K971350Series XE, Series SE, Series TE
Summary page 1
…Aseptico) K020137 3. Aseptico Autoclavable Handpieces (Aseptico) K020137, Series Xe, Se, Te (Micro Mega) K 971350 2. INTENDED USE ANTHOGYR contra angles and handpieces are autoclavable devices intended for a wide range of procedures in…
Micro-Mega Societe Anonyme1997—

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K092412Strong Implant HandpiecesSaeshin Precision Co., Ltd.200915
K060317Anthogyr Contra Angles and HandpiecesEst. Anthogyr20065
K070084Montblanc Implantology Contra Angle ControlEst. Anthogyr20074
K093894Anthogyr Impulsion Implantology Contra-AngleAnthogyr20103
K111532Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas20111

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K092412 (Saeshin Precision Co., Ltd., 2009) has gone furthest, with 15 descendants of its own.

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.

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 and handpieces are devices intended for a wide range of dental procedures including:

Endodontic surgeries, such as root canal preparations

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

General dentistry such as removing carious material, cavity and crow preparation, finishing tooth preparations, restorations and polishing teeth

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K040674: Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040674

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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