510(k) · Cleared
ClearedInclusive Tapered Implant System
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 May 23, 2016 as substantially equivalent to K121406 (Prismatik Dentalcraft, Inc., 2013) and 1 other predicate after a 210-day review. Its family tree reaches back 4 generations to 2003. 3 later devices descend from it.
- Decided
- May 23, 2016
- Review
- 210 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K031106 (2003). 6 ancestors in all, the oldest K953235 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK031106 Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX…Imtec Corp. · 2003 · Recalled
- 3 generations backK100932 Inclusive Mini ImplantPrismatik Dentalcraft, Inc. · 2010
- 2 generations backK121406 Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2013
- 1 generation backK143353 Hahn Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2015
- This deviceK153099 Inclusive Tapered Implant SystemPrismatik Dentalcraft, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK171728 MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC · 2017
- 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- K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC · 2017 · 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 |
|---|---|---|---|---|---|
| −4 | K031106 | Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22… | Imtec Corp. | 2003 | 1 |
| −3 | K100932 | Inclusive Mini Implant | Prismatik Dentalcraft, Inc. | 2010 | — |
| −2 | K121406 | Inclusive Tapered Implant System | Prismatik Dentalcraft, Inc. | 2013 | — |
| −1 | K143353 | Hahn Tapered Implant System | Prismatik Dentalcraft, Inc. | 2015 | — |
| 0 (this device) | K153099 | Inclusive Tapered Implant System | Prismatik Dentalcraft, Inc. | 2016 | — |
| +1 | K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | Sterngold Dental, LLC | 2017 | — |
| +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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121406 | Inclusive Tapered Implant SystemSummary page 4…Dental C. IDENTIFICATION OF PREDICATE DEVICE Primary Predicate: Inclusive Tapered Implant System (K121406, Cleared on 2/22/2013) Reference Predicate: Hahn Tapered Implant System… | 2013 |
| * | K143353 | Hahn Tapered Implant SystemSummary page 4…(K121406, Cleared on 2/22/2013) Reference Predicate: Hahn Tapered Implant System (K143353, Cleared on 4/2/2015) Page 18 === Page 5… | 2015 |
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 |
|---|---|---|---|
| K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | 2017 | 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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K171728 (Sterngold Dental, LLC, 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K121406.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Tapered Implant System is indicated for use in maxillary and mandibular partially or fully edentulous cases, to support single, multiple-unit, and overdenture restorations. The implants are 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/K153099 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153099: Inclusive Tapered Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153099
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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