510(k) · Cleared
ClearedMicrodent Genius Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Microdent · DZE Implant, Endosseous, Root-Form
Cleared on Jun 2, 2015 as substantially equivalent to K083805 (Dentsply Intl., Inc., 2009) and 2 other predicates after a 390-day review. Its family tree reaches back 8 generations to 1990.
- Decided
- Jun 2, 2015
- Review
- 390 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K894595 (1990). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 7 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 6 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 5 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 4 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 2 generations backK041509 Ankylos Dental Implant SystemFriadent GmbH · 2004
- 1 generation backK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
- This deviceK141188 Microdent Genius Implant SystemImplant Microdent · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −7 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −6 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −5 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −4 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −2 | K041509 | Ankylos Dental Implant System | Friadent GmbH | 2004 | — |
| −1 | K083805 | Ankylos C/X Dental Implant System | Dentsply Intl., Inc. | 2009 | — |
| 0 (this device) | K141188 | Microdent Genius Implant System | Implant Microdent | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2008 | 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 |
|---|---|---|---|
| * | K083805 | Ankylos C/X Dental Implant SystemSummary page 4…II Regulation Number: 21 CFR 872.3640 C. Identification of Legally Marketed Predicate Device ANKYLOS C/X Dental Implant – K083805 (primary predicate) ANKYLOS Balance Base abutment C/ – K041509 (reference predicate) XiVE Dental Implant System (Ball… | 2009 |
| * | K041509 | Ankylos Dental Implant SystemSummary page 4…2.3640 C. Identification of Legally Marketed Predicate Device ANKYLOS C/X Dental Implant – K083805 (primary predicate) ANKYLOS Balance Base abutment C/ – K041509 (reference predicate) XiVE Dental Implant System (Ball and Socket Attachment) – K021318 (reference predicate) D.… | 2004 |
| * | K021318 | Xive Dental Implant SystemSummary page 4…lant – K083805 (primary predicate) ANKYLOS Balance Base abutment C/ – K041509 (reference predicate) XiVE Dental Implant System (Ball and Socket Attachment) – K021318 (reference predicate) D. Description of the Device Microdent Genius Implant System is comprised of dental impla… | 2002 |
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 25 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 2 of the 21 ancestors have a recall of any class.
- 7 other devices also cite its predicate K083805.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Microdent Genius Implant System is indicated for surgical placement in the upper or lower jaw arches, for single-stage or two-stage surgical procedures and cemented, screw retained restorations or overdentures. Microdent Genius Implant System is intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
Small diameter implants are indicated only for replacement of central and lateral incisors in the maxillar and mandible.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141188: Microdent Genius Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141188
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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