510(k) · Cleared
ClearedMontblanc Implantology and Omnipratique Contra-Angles
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 May 22, 2009 as substantially equivalent to K060317 (Est. Anthogyr, 2006) and 1 other predicate after a 70-day review. Its family tree reaches back 4 generations to 1997. 3 later devices descend from it.
- Decided
- May 22, 2009
- Review
- 70 days
- Class
- Class I
- Product code
- EFA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971350 (1997). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 3 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 2 generations backK060317 Anthogyr Contra Angles and HandpiecesEst. Anthogyr · 2006
- 1 generation backK070084 Montblanc Implantology Contra Angle ControlEst. Anthogyr · 2007
- This deviceK090676 Montblanc Implantology and Omnipratique Contra-AnglesAnthogyr · 2009
- Descendant · cites it directly · 1 of its ownK111532 Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas · 2011
- Descendant · 2 generations on · 0 of its ownK171155 Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK102241 Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011
Most influential descendants
Showing 3 of 3 · See all- K111532Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas · 2011 · cites it directly1descendant
- K171155Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017 · 2 generations on0descendants
- K102241Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −3 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −2 | K060317 | Anthogyr Contra Angles and Handpieces | Est. Anthogyr | 2006 | — |
| −1 | K070084 | Montblanc Implantology Contra Angle Control | Est. Anthogyr | 2007 | — |
| 0 (this device) | K090676 | Montblanc Implantology and Omnipratique Contra-Angles | Anthogyr | 2009 | — |
| +1 | K111532 | Montblanc Surgical Contra-Angle and Straight Handpiece | Anthogyr Sas | 2011 | — |
| +2 | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | 2017 | 8 |
| +1 | K102241 | Anthogyr Implanteo Implantology and Dental Surgical Motor Unit | Anthogyr Sas | 2011 | — |
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 |
|---|---|---|
| 2011 | 2 | 0 |
| 2017 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060317 | Anthogyr Contra Angles and HandpiecesSummary page 1SPECIAL 510(k) - MODIFICATION TO K060317 AND K070084 antho.gyr ANTHOGYR DENTAL CONTRA-ANGLES NEM… | 2006 |
| * | K070084 | Montblanc Implantology Contra Angle ControlSummary page 1SPECIAL 510(k) - MODIFICATION TO K060317 AND K070084 antho.gyr ANTHOGYR DENTAL CONTRA-ANGLES NEM… | 2007 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K111532 (Anthogyr Sas, 2011) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K060317.
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. 2009, 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 'MontBlanc" and ANTHOGYR's fully autoclavable contra-angles 'MontBIanc" 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, restaurations and polishing teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090676: Montblanc Implantology and Omnipratique 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/K090676
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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