510(k) Report

510(k) · Cleared

Cleared

Anthogyr Contra Angles and Handpieces

K060317510(k) TraditionalCleared Apr 28, 200679-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

Est. Anthogyr · EGS Handpiece, Contra- And Right-Angle Attachment, Dental

Cleared on Apr 28, 2006 as substantially equivalent to K040674 (Anthogyr, 2004) after a 79-day review. Its family tree reaches back 2 generations to 1997. 5 later devices descend from it.

Decided
Apr 28, 2006
Review
79 days
Class
Class I
Product code
EGS
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K971350 (1997). 3 ancestors in all. 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2007: 1 descendant cleared2009: 1 descendant cleared2011: 2 descendants cleared2017: 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: 2 descendants2 generations forward: 2 descendants3 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 deviceK060317 Anthogyr Contra Angles and HandpiecesEst. Anthogyr · 2006
  4. Descendant · cites it directly · 4 of its ownK070084 Montblanc Implantology Contra Angle ControlEst. Anthogyr · 2007
  5. Descendant · cites it directly · 3 of its ownK090676 Montblanc Implantology and Omnipratique Contra-AnglesAnthogyr · 2009
  6. Descendant · 2 generations on · 1 of its ownK111532 Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas · 2011
  7. Descendant · 3 generations on · 0 of its ownK171155 Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017 · Recalled
  8. Descendant · 2 generations on · 0 of its ownK102241 Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011

Most influential descendants

Showing 5 of 5 · See all
  • K070084Montblanc Implantology Contra Angle ControlEst. Anthogyr · 2007 · cites it directly4descendants
  • K090676Montblanc Implantology and Omnipratique Contra-AnglesAnthogyr · 2009 · cites it directly3descendants
  • K111532Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas · 2011 · 2 generations on1descendant
  • K171155Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017 · 3 generations on0descendants
  • K102241Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011 · 2 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)K060317Anthogyr Contra Angles and HandpiecesEst. Anthogyr2006—
+1K070084Montblanc Implantology Contra Angle ControlEst. Anthogyr2007—
+1K090676Montblanc Implantology and Omnipratique Contra-AnglesAnthogyr2009—
+2K111532Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas2011—
+3K171155Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc.20178
+2K102241Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201120
201710
FIG. 1 — Lineage of K060317, 1997–2017Source: 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 EGS? 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 EGS device

  1. #1 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · 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
*K040674Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra Angles
Summary page 1
SPECIAL 510(k) - MODIFICATION TO K040674 anthoe/' ANTHOGYR DENTAL CONTRA-ANGLES AND HANDPIECES 510(K) SUMMARY OF SAFETY AND EFFECTIVENE…
Anthogyr2004—

Also cleared against K040674: 4 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K070084Montblanc Implantology Contra Angle ControlEst. Anthogyr20074
K090676Montblanc Implantology and Omnipratique Contra-AnglesAnthogyr20093

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 9 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K070084 (Est. Anthogyr, 2007) has gone furthest, with 4 descendants of its own.
  • 4 other devices also cite its predicate K040674.

How does its category compare?

All EGS devices

EGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EGS

2in 2025

2007: 12009: 12010: 22011: 32012: 32013: 12014: 22015: 32017: 22018: 12019: 32020: 12021: 12022: 42023: 12024: 12025: 2
2007high 4 (2022) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EGS

189in 2022

2011: 104 days median2012: 288 days median2015: 245 days median2019: 276 days median2022: 189 days median
2007high 288 (2012) · low 104 (2011)2026

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

Recalls per year · EGS

1in 2023

2023: 1
2007high 1 (2023) · low 0 (2007)2026

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

Adverse event reports per year · EGS

82in 2025

2007: 22008: 142009: 452010: 742011: 22012: 32013: 22014: 382015: 1662016: 2992017: 3162018: 2302019: 2192020: 1912021: 2942022: 2792023: 1152024: 812025: 82
2007high 316 (2017) · low 2 (2007)2025

MAUDE reports naming product code EGS, 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—02
20080—014
20091—045
20102—074
2011310402
2012328803
20131—02
20142—038
201532450166
20160—0299
20172—0316
20181—0230
201932760219
20201—0191
20211—0294
202241890279
20231—1115
20241—081
20252—082
20260—0—

What is it indicated for?

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

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

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

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K060317: Anthogyr Contra Angles and Handpieces.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060317

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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