510(k) · Cleared
ClearedMontblanc Surgical Contra-Angle and Straight Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anthogyr Sas · EGS Handpiece, Contra- And Right-Angle Attachment, Dental
Cleared on Oct 7, 2011 as substantially equivalent to K040674 (Anthogyr, 2004) and 3 other predicates after a 126-day review. Its family tree reaches back 5 generations to 1997. 1 later device descends from it.
- Decided
- Oct 7, 2011
- Review
- 126 days
- Class
- Class I
- Product code
- EGS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K971350 (1997). 10 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 4 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 3 generations backK060317 Anthogyr Contra Angles and HandpiecesEst. Anthogyr · 2006
- 2 generations backK070084 Montblanc Implantology Contra Angle ControlEst. Anthogyr · 2007
- 1 generation backK090676 Montblanc Implantology and Omnipratique Contra-AnglesAnthogyr · 2009
- This deviceK111532 Montblanc Surgical Contra-Angle and Straight HandpieceAnthogyr Sas · 2011
- Descendant · cites it directly · 0 of its ownK171155 Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K171155Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −4 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −3 | K060317 | Anthogyr Contra Angles and Handpieces | Est. Anthogyr | 2006 | — |
| −2 | K070084 | Montblanc Implantology Contra Angle Control | Est. Anthogyr | 2007 | — |
| −1 | K090676 | Montblanc Implantology and Omnipratique Contra-Angles | Anthogyr | 2009 | — |
| 0 (this device) | K111532 | Montblanc Surgical Contra-Angle and Straight Handpiece | Anthogyr Sas | 2011 | — |
| +1 | K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | 2017 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 K251869 Disposable Prophy Angle (3399-60, 3399-090…score 10.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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…, TradeNamesMontRlanc Surgical contra-angle handpiece and straight handpiece ANTHOGYR Contra-angle and Hondpiece (K040674) arkted Legaly ANTHOGYR MontBlanc Contra-angle (K(090676) devces predcat… | 2004 |
| * | K090676 | Montblanc Implantology and Omnipratique Contra-AnglesSummary page 1…handpiece ANTHOGYR Contra-angle and Hondpiece (K040674) arkted Legaly ANTHOGYR MontBlanc Contra-angle (K(090676) devces predcat WH Surgical contra-angle Handpieces (1(011061) WH Surgi… | 2009 |
| * | K011061 | Surgical Contra-Angel Handpieces Types WS-56E,WS-75E/KM,WS-92 E/3,Surgical Straight…Summary page 1…arkted Legaly ANTHOGYR MontBlanc Contra-angle (K(090676) devces predcat WH Surgical contra-angle Handpieces (1(011061) WH Surgical contra-angle and straight handpiece (1(080939) Classification… | 2001 |
| * | K080939 | Surgical Handpieces, Mikro Saw HandpiecesSummary page 1…redcat WH Surgical contra-angle Handpieces (1(011061) WH Surgical contra-angle and straight handpiece (1(080939) Classification Name Dental handpieces and accessories Class Product Code EGS CFR section 872… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | 2017 | 0 |
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 14 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K171155 (Nakanishi, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K040674.
How does its category compare?
All EGS devicesEGS Handpiece, Contra- And Right-Angle Attachment, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · EGS
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EGS
189in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EGS
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EGS
82in 2025
MAUDE reports naming product code EGS, 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 | 2 |
| 2008 | 0 | — | 0 | 14 |
| 2009 | 1 | — | 0 | 45 |
| 2010 | 2 | — | 0 | 74 |
| 2011 | 3 | 104 | 0 | 2 |
| 2012 | 3 | 288 | 0 | 3 |
| 2013 | 1 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 38 |
| 2015 | 3 | 245 | 0 | 166 |
| 2016 | 0 | — | 0 | 299 |
| 2017 | 2 | — | 0 | 316 |
| 2018 | 1 | — | 0 | 230 |
| 2019 | 3 | 276 | 0 | 219 |
| 2020 | 1 | — | 0 | 191 |
| 2021 | 1 | — | 0 | 294 |
| 2022 | 4 | 189 | 0 | 279 |
| 2023 | 1 | — | 1 | 115 |
| 2024 | 1 | — | 0 | 81 |
| 2025 | 2 | — | 0 | 82 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indications are very widespread in the field of implantology and surgery. The mentioned handpieces have been developed especially for the following applications
MontBlanc Surgical contra-angle handpiece: for e.g. hemisection, wisdom tooth extraction.
MontBlanc Surgical straight handpiece: for e.g. application in the area of the front teeth, root tip resection, bone removal, osteotomy on the upper and lower jaw, preprosthetic surgical osteaplasty, sequestrum removal, fenestration on the alveolar appendix, apical ventilation, bone osteoplasty, bone smoothing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111532 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111532: Montblanc Surgical Contra-Angle and Straight Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111532
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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