510(k) · Cleared
ClearedChampions Implants GMBH Mimi 1-Piece Precision Implant, Model 1000 UP to 6000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Champions Implants GmbH · DZE Implant, Endosseous, Root-Form
Cleared on Jan 7, 2010 as substantially equivalent to K063523 (Zimmer Dental, Inc., 2007) after a 259-day review. Its family tree reaches back 1 generation to 2007. 3 later devices descend from it.
- Decided
- Jan 7, 2010
- Review
- 259 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063523 (2007). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK063523 Zimmer One Piece Implant, 3.7MM and 4.7MM, Models ZOP37S10, 11, 13…Zimmer Dental, Inc. · 2007
- This deviceK091182 Champions Implants GMBH Mimi 1-Piece Precision Implant, Model 1000…Champions Implants GmbH · 2010
- Descendant · cites it directly · 2 of its ownK110548 Osi O-Ball Abutment Head ImplantsJuell Dental · 2011
- Descendant · 2 generations on · 1 of its ownK213576 Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022
- Descendant · 3 generations on · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
Most influential descendants
Showing 3 of 3 · See all- K110548Osi O-Ball Abutment Head ImplantsJuell Dental · 2011 · cites it directly2descendants
- K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical · 2022 · 2 generations on1descendant
- K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063523 | Zimmer One Piece Implant, 3.7MM and 4.7MM, Models ZOP37S10, 11, 13, 16… | Zimmer Dental, Inc. | 2007 | — |
| 0 (this device) | K091182 | Champions Implants GMBH Mimi 1-Piece Precision Implant, Model 1000 UP to 6000 | Champions Implants GmbH | 2010 | — |
| +1 | K110548 | Osi O-Ball Abutment Head Implants | Juell Dental | 2011 | — |
| +2 | K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical | 2022 | — |
| +3 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K063523 | Zimmer One Piece Implant, 3.7MM and 4.7MM, Models ZOP37S10, 11, 13, 16; ZOP37A10, 11…Summary page 2…4. SUBSTANTIAL EQUIVALENCE *The MIMI® 1-Piece PrecisionlImplant System is substantially equivalent to the Zimmer One-Piece Implant, 3,7mm and 4,7mm, K063523. 5. BIOcomP:ATIBITmr The biocompatibility is guaranteed by fulfilling the requirements of ISO 5832-2:1999, ISO 5832-3-3:1996, IS… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110548 | Osi O-Ball Abutment Head Implants | 2011 | 2 |
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?
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Champions Implants MIMI 1-Piece Precision Implant is intended to support single or multi-unit restorations in both long-term and temrporary applications throughout the maxillary and mandibular arches. The MIMI 1-Piece Precision Implant is indicated for immediate loading when there is good primary stability and an appropriate occlusal load. The MIMI 1-Piece Precision Implants have diameters from 4,0 to 4,5mm and are available in length of 10 to 16mm.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091182: Champions Implants GMBH Mimi 1-Piece Precision Implant, Model 1000 UP to 6000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091182
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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