510(k) · Cleared
ClearedPYRAMIDION Dental Implants and Prostheses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentack Implants, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Dec 13, 2018 as substantially equivalent to K152188 (Dentack Impants, Ltd., 2016) after a 255-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Dec 13, 2018
- Review
- 255 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930071 (1994). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK930071 Sargon Cylindro-Blade ImplantSargon Ent., Inc. · 1994
- 2 generations backK981141 Sargon Immediate Load Implant, Model DSargon Ent., Inc. · 1999
- 1 generation backK152188 QUAD Dental Implants and ProsthesesDentack Impants, Ltd. · 2016
- This deviceK180859 PYRAMIDION Dental Implants and ProsthesesDentack Implants, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930071 | Sargon Cylindro-Blade Implant | Sargon Ent., Inc. | 1994 | — |
| −2 | K981141 | Sargon Immediate Load Implant, Model D | Sargon Ent., Inc. | 1999 | — |
| −1 | K152188 | QUAD Dental Implants and Prostheses | Dentack Impants, Ltd. | 2016 | — |
| 0 (this device) | K180859 | PYRAMIDION Dental Implants and Prostheses | Dentack Implants, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 |
|---|---|---|---|
| * | K152188 | QUAD Dental Implants and ProsthesesSummary page 5…nt to the following Predicate Devices: 3.1 Primary Predicate Device: DenTack's QUAD Dental Implants and Prostheses, cleared under 510(k) number K152188 on January 28, 2016. 3.2 Reference Device: Biomet's Biomet 3i T3 Dental Abutments, cleared under 510(k) K072642… | 2016 |
| † | K072642 | Biomet 3I Dental Abutments and Restorative Components | 2007 |
| † | K092035 | Bicon Implants with a 2.5MM Internal Connection | 2009 |
| † | K150571 | 3i T3 Short Implants | 2015 |
| † | K112279 | Quantum Dental Implant System | 2012 |
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 24 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
DenTack PYRAMIDION Dental Implants and Prostheses are intended for surgical placement in the maxilla and/or in the mandible to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous jaws utilizing conventional, delayed or immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants in 5-6mm length are indicated for delayed loading only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180859 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180859: PYRAMIDION Dental Implants and Prostheses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180859
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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