510(k) · Cleared
ClearedInclusive Mini Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prismatik Dentalcraft, Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 27, 2010 as substantially equivalent to K031106 (Imtec Corp., 2003) after a 266-day review. Its family tree reaches back 1 generation to 2003. 15 later devices descend from it.
- Decided
- Dec 27, 2010
- Review
- 266 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K031106 (2003). 15 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK031106 Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX…Imtec Corp. · 2003 · Recalled
- This deviceK100932 Inclusive Mini ImplantPrismatik Dentalcraft, Inc. · 2010
- Descendant · cites it directly · 11 of its ownK121406 Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2013
- Descendant · 2 generations on · 10 of its ownK143353 Hahn Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK170044 Inclusive Titanium Abutments compatible with: MegaGen AnyRidge…Prismatik Dentalcraft, Inc. · 2017
- Descendant · 3 generations on · 4 of its ownK191222 Inclusive Titanium Abutments compatible with: Dentsply Implants…Prismatik Dentalcraft, Inc. · 2019
- Descendant · 2 generations on · 3 of its ownK153099 Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2016
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K121406Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2013 · cites it directly11descendants
- K143353Hahn Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2015 · 2 generations on10descendants
- K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc. · 2017 · 2 generations on5descendants
- K191222Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant…Prismatik Dentalcraft, Inc. · 2019 · 3 generations on4descendants
- K153099Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22… | Imtec Corp. | 2003 | 1 |
| 0 (this device) | K100932 | Inclusive Mini Implant | Prismatik Dentalcraft, Inc. | 2010 | — |
| +1 | K121406 | Inclusive Tapered Implant System | Prismatik Dentalcraft, Inc. | 2013 | — |
| +2 | K143353 | Hahn Tapered Implant System | Prismatik Dentalcraft, Inc. | 2015 | — |
| +2 | K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | Prismatik Dentalcraft, Inc. | 2017 | — |
| +3 | K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech… | Prismatik Dentalcraft, Inc. | 2019 | — |
| +2 | K153099 | Inclusive Tapered Implant System | Prismatik Dentalcraft, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (2)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22, MSH-XXSummary page 1…Class 11 Panel: Dental DZE C. IDENTIFICATION OF PREDICATE DEVICE Trade/Proprietary Name: IMTEC Sendlax MDI and MIDI Plus, K031106 (8/12/2003) Trade/Proprietary Name: IMTEC MDI MII One-Piece Implant, 2.9mm, K08165 (9/19/… | 2003 |
| Kept off the family tree | K081655 | FDA’s K081655 is Powder Free Vinyl Patient Examination Gloves (Light Yellow) Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2008 |
What descends from it? (15)
See all 153 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?
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?
Inclusive Mini Implants are self-tapping threaded titanium screws indicated for long-term applications. Inclusive Mini Implants may also be used for provisional applications. These devices will allow immediate loading and long-term stabilization of dentures and provisional stabilization of dentures while standard implants heal. To be used for immediate loading only in the presence of primary stability and appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100932 · printed Nov 5, 2026
Cite this page
510(k) Report. “K100932: Inclusive Mini Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K100932
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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