510(k) · Cleared
ClearedAbsoanchor Microimplant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentos, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on May 16, 2006 as substantially equivalent to K042965 (Dentaurum, Inc., 2005) and 2 other predicates after a 118-day review. Its family tree reaches back 6 generations to 1990. 19 later devices descend from it.
- Decided
- May 16, 2006
- Review
- 118 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K894844 (1990). 18 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations backK973353 Bonding BaseStraumann USA · 1997
- 4 generations backK982509 Ortho Implant and AccessoriesStraumann USA · 1998
- 3 generations backK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
- 2 generations backK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
- 1 generation backK042965 Tomas PinDentaurum, Inc. · 2005
- This deviceK060126 Absoanchor MicroimplantDentos, Inc. · 2006
- Descendant · cites it directly · 14 of its ownK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008
- Descendant · 2 generations on · 13 of its ownK090476 Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009
- Descendant · 3 generations on · 5 of its ownK110392 PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011
- Descendant · 4 generations on · 3 of its ownK161335 Dual Top Screw SystemJeil Medical Corporation · 2017
- Descendant · cites it directly · 2 of its ownK063149 Orthodontic Taads (Temporary Anatomical Anchor Device System)T.O.a.D.S., LLC · 2007
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K071490Leone Orthodontic Mini ImplantLeone S.P.A. · 2008 · cites it directly14descendants
- K090476Syntec Orthodontic Mini ScrewSyntec Scientific Corp. · 2009 · 2 generations on13descendants
- K110392PSM Lomas / Benefit ScrewsPsm Medical Solutions · 2011 · 3 generations on5descendants
- K161335Dual Top Screw SystemJeil Medical Corporation · 2017 · 4 generations on3descendants
- K063149Orthodontic Taads (Temporary Anatomical Anchor Device System)T.O.a.D.S., LLC · 2007 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −5 | K973353 | Bonding Base | Straumann USA | 1997 | — |
| −4 | K982509 | Ortho Implant and Accessories | Straumann USA | 1998 | — |
| −3 | K031936 | Osteomed Orthodontic Screw System | Osteomed LP | 2004 | — |
| −2 | K033767 | Dual Top Anchor System Screws | Jeil Medical Corporation | 2004 | — |
| −1 | K042965 | Tomas Pin | Dentaurum, Inc. | 2005 | — |
| 0 (this device) | K060126 | Absoanchor Microimplant | Dentos, Inc. | 2006 | — |
| +1 | K071490 | Leone Orthodontic Mini Implant | Leone S.P.A. | 2008 | — |
| +2 | K090476 | Syntec Orthodontic Mini Screw | Syntec Scientific Corp. | 2009 | — |
| +3 | K110392 | PSM Lomas / Benefit Screws | Psm Medical Solutions | 2011 | — |
| +4 | K161335 | Dual Top Screw System | Jeil Medical Corporation | 2017 | — |
| +1 | K063149 | Orthodontic Taads (Temporary Anatomical Anchor Device System) | T.O.a.D.S., LLC | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 DZE? 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 DZE device
- #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K042965 | Tomas PinSummary page 1…lant) Classification Name: Implant, Endosseous, Product Code DZE Common/Usual Name: Dental Implant 2. Equivalent Legally Marketed Devices: Dentaurumn Tomas-pin (K042965), Jeil Medical Dual Top Anchor System Screws (K033767), and IMTEC MIDI Ortho (K042289). 3. Description of the Device: The D… | 2005 |
| * | K033767 | Dual Top Anchor System ScrewsSummary page 1…t Code DZE Common/Usual Name: Dental Implant 2. Equivalent Legally Marketed Devices: Dentaurumn Tomas-pin (K042965), Jeil Medical Dual Top Anchor System Screws (K033767), and IMTEC MIDI Ortho (K042289). 3. Description of the Device: The Dentos AbsoAnchor Orthodontic Microimplant is composed of… | 2004 |
| * | K042289 | Mdi OrthoSummary page 1…Dental Implant 2. Equivalent Legally Marketed Devices: Dentaurumn Tomas-pin (K042965), Jeil Medical Dual Top Anchor System Screws (K033767), and IMTEC MIDI Ortho (K042289). 3. Description of the Device: The Dentos AbsoAnchor Orthodontic Microimplant is composed of Titanium- 6Aluminum-4Vanadium… | 2004 |
What descends from it? (19)
See all 193 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 16 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- None of the 18 ancestors has a recall.
- Of its descendants, K071490 (Leone S.P.A., 2008) has gone furthest, with 14 descendants of its own.
- 6 other devices also cite its predicate K042965.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 2025
MAUDE reports naming product code DZE, 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 | 43 | 107 | 11 | 225 |
| 2008 | 61 | 118 | 4 | 393 |
| 2009 | 41 | 110 | 3 | 164 |
| 2010 | 34 | 162 | 3 | 360 |
| 2011 | 26 | 194 | 0 | 362 |
| 2012 | 39 | 174 | 11 | 358 |
| 2013 | 42 | 195 | 1 | 391 |
| 2014 | 36 | 265 | 7 | 1,124 |
| 2015 | 36 | 215 | 3 | 2,894 |
| 2016 | 40 | 219 | 15 | 1,116 |
| 2017 | 48 | 223 | 4 | 9,719 |
| 2018 | 41 | 200 | 4 | 12,892 |
| 2019 | 31 | 231 | 8 | 167,016 |
| 2020 | 41 | 230 | 0 | 255,524 |
| 2021 | 34 | 182 | 6 | 479,618 |
| 2022 | 34 | 243 | 0 | 483,224 |
| 2023 | 35 | 248 | 0 | 537,585 |
| 2024 | 40 | 222 | 1 | 473,629 |
| 2025 | 31 | 184 | 1 | 465,788 |
| 2026 | 15 | 194 | 2 | — |
What is it indicated for?
The intended purpose of the AbsoAnchor microimplant is to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060126 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060126: Absoanchor Microimplant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060126
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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