510(k) · Cleared
ClearedAnthogyr Implanteo Implantology and Dental Surgical Motor Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anthogyr Sas · EBW Controller, Foot, Handpiece And Cord
Cleared on Mar 23, 2011 as substantially equivalent to K041279 (Anthogyr, 2004) and 5 other predicates after a 226-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Mar 23, 2011
- Review
- 226 days
- Class
- Class I
- Product code
- EBW
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K971350 (1997). 17 ancestors in all, the oldest K911068 (1991). No later device cites it as a predicate yet.
- 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 deviceK102241 Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011
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) | 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 |
|---|---|---|
| 1991 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 EBW? 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 EBW device
- #1 K251701 Star E900 Electric Systemscore 12.2 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K041279 | Implanteo Implantology MotorSummary page 2…HOGYR "IMPLANTEO" implantalogy and dental surgery motor unit has the same fundamental scientific technology, operating principle and intended use as ANTHOGYR IMPLANTEO (K041279) with ANTHOGYR knplantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angie (1(970953) or W&H impla… | 2004 |
| * | K090676 | Montblanc Implantology and Omnipratique Contra-AnglesSummary page 2…motor unit has the same fundamental scientific technology, operating principle and intended use as ANTHOGYR IMPLANTEO (K041279) with ANTHOGYR knplantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angie (1(970953) or W&H implantMED (K052741) with contra-angle (K080939). 4.… | 2009 |
| * | K092214 | Chiropro L SystemSummary page 2…tal scientific technology, operating principle and intended use as ANTHOGYR IMPLANTEO (K041279) with ANTHOGYR knplantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angie (1(970953) or W&H implantMED (K052741) with contra-angle (K080939). 4. PERFOPAANCE DATA ANTHO&YR Contra… | 2009 |
| * | K052741 | Implantmed SI-915 (115V Version); Implantmed SI-923 (230V Version) Incl. AccessoriesSummary page 2…se as ANTHOGYR IMPLANTEO (K041279) with ANTHOGYR knplantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angie (1(970953) or W&H implantMED (K052741) with contra-angle (K080939). 4. PERFOPAANCE DATA ANTHO&YR Contra angles & I-andpieces conform to the following FDA recognized… | 2006 |
| * | K970953 | E-Type Speed Reducer Contra AngleSummary page 2…ng principle and intended use as ANTHOGYR IMPLANTEO (K041279) with ANTHOGYR knplantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angie (1(970953) or W&H implantMED (K052741) with contra-angle (K080939). 4. PERFOPAANCE DATA ANTHO&YR Contra angles & I-andpieces conform to t… | 1997 |
| * | K080939 | Surgical Handpieces, Mikro Saw HandpiecesSummary page 2…41279) with ANTHOGYR knplantology contra-angle (K090676) or BIEN-AIR CHIROPRO L (K092214) with NSK contra-angie (1(970953) or W&H implantMED (K052741) with contra-angle (K080939). 4. PERFOPAANCE DATA ANTHO&YR Contra angles & I-andpieces conform to the following FDA recognized Consensus standards: /ISO… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 1.8 years on median.
- 2 of the 17 ancestors have a recall of any class.
How does its category compare?
All EBW devicesEBW Controller, Foot, Handpiece And Cord: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · EBW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EBW
220in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EBW
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EBW
13in 2025
MAUDE reports naming product code EBW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 5 | 112 | 0 | 16 |
| 2010 | 1 | — | 0 | 18 |
| 2011 | 3 | 226 | 0 | 1 |
| 2012 | 1 | — | 0 | 5 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 3 | 189 | 0 | 4 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 1 | — | 0 | 6 |
| 2017 | 4 | 227 | 0 | 13 |
| 2018 | 1 | — | 0 | 46 |
| 2019 | 2 | — | 0 | 55 |
| 2020 | 1 | — | 0 | 71 |
| 2021 | 2 | — | 0 | 57 |
| 2022 | 6 | 479 | 0 | 31 |
| 2023 | 0 | — | 0 | 17 |
| 2024 | 4 | 268 | 0 | 14 |
| 2025 | 3 | 220 | 0 | 13 |
| 2026 | 3 | 269 | 0 | — |
What is it indicated for?
ANTHOGYR's IMPLANTEO implantology and dental surgery motor unit aire indicated to perform dental implant surgery, such as perforating the bone and tapping and threading procedures required before placement of implant prosthetics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102241 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102241: Anthogyr Implanteo Implantology and Dental Surgical Motor Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102241
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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