510(k) · Cleared
Recalled · 2009Mdi Mii One-Piece Implant, 2.9MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Imtec Corp. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 19, 2008 as substantially equivalent to K063364 (Alpha-Bio Tec, Ltd., 2007) and 3 other predicates after a 99-day review. Its family tree reaches back 10 generations to 1996. 141 later devices descend from it. It has been recalled once.
- Decided
- Sep 19, 2008
- Review
- 99 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 10 generations to K960026 (1996). 78 ancestors in all, the oldest K874590 (1988). 141 later devices descend from it, 8 citing it directly.
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 6 generations between
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 1 generation backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- This deviceK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008
- Descendant · cites it directly · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- Descendant · 2 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- Descendant · 2 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- Descendant · 2 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Show all 10 generations
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 8 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 7 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 1 generation backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- This deviceK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008
Showing 5 of 141 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 141 · See all- K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · cites it directly127descendants
- K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 2 generations on123descendants
- K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · 2 generations on109descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 2 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −9 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −3 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −2 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −1 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| 0 (this device) | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | — |
| +1 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| +2 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| +2 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| +2 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 6 | 0 |
| 2019 | 8 | 0 |
| 2020 | 13 | 0 |
| 2021 | 12 | 0 |
| 2022 | 15 | 0 |
| 2023 | 18 | 0 |
| 2024 | 15 | 0 |
| 2025 | 23 | 0 |
| 2026 | 12 | 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? (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 |
|---|---|---|---|
| * | K063364 | Alpha Bio Dental Implant SystemSummary page 1…plant Regulation No: 872.3640 Class: II Panel: Dental 3. Predicate Device (s): Alpha Bio 3.0mm One-Piece Implant K063364 Zimmer® One-Piece Implant, 3.0mm, Straight K052997 IMTE… | 2007 |
| * | K052997 | Zimmer Dental One-Piece ImplantSummary page 1…Device (s): Alpha Bio 3.0mm One-Piece Implant K063364 Zimmer® One-Piece Implant, 3.0mm, Straight K052997 IMTEC Sendax MDI and MDI Plus K031106 IMTEC Endure Impl… | 2006 |
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 1…mplant K063364 Zimmer® One-Piece Implant, 3.0mm, Straight K052997 IMTEC Sendax MDI and MDI Plus K031106 IMTEC Endure Implant System K030243 4. Device Description: The IMTEC MDI MII2.9mm o… | 2003 |
| * | K030243 | Endure Implant, Model 3508,3511,3514,4308,4311,4314Summary page 1…lant, 3.0mm, Straight K052997 IMTEC Sendax MDI and MDI Plus K031106 IMTEC Endure Implant System K030243 4. Device Description: The IMTEC MDI MII2.9mm one-piece implant is a one piece endosseous dental implant that is a… | 2003 |
What descends from it? (141)
See all 1418 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123022 | Neodent Implant System | 2013 | 127 |
| K170392 | S.I.N. Implant System | 2017 | 16 |
| K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | 2017 | 2 |
| K131701 | Z5MLB, Z5MLC | 2013 | 1 |
| K121707 | Lew Mdi O-Ball Collared Implant, | 2012 | 1 |
| K133327 | Saturno (TM) Overdenture Implant System | 2014 | 0 |
| K121281 | Simpli Simpler Implant System | 2013 | 0 |
| K122052 | Minifix Ball Minifix One | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 7, 2009 | Not classified | Z-1997-2009 | Other | Size printed on product packaging does not match size of enclosed product. |
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 9 months on median.
- 8 of the 78 ancestors have a recall of any class.
- Of its descendants, K123022 (Jjgc Industria E Comercio DE Materiais Dentarios S, 2013) has gone furthest, with 127 descendants of its own.
- 12 other devices also cite its predicate K063364.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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 M11 Implant is intended to support single or multi-unit restorations in both long-term and temporary applications throughout the maxillary and mandibular arches. The MII implant is indicated for immediate loading when good primary stability is achieved. Additionally, this device will permit stability and long term fixation of upper and lower dentures in edentulous cases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081653 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081653: Mdi Mii One-Piece Implant, 2.9MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081653
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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