510(k) · Cleared
ClearedQUAD Dental Implants and Prostheses
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentack Impants, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Jan 28, 2016 as substantially equivalent to K981141 (Sargon Ent., Inc., 1999) after a 176-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Jan 28, 2016
- Review
- 176 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930071 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK930071 Sargon Cylindro-Blade ImplantSargon Ent., Inc. · 1994
- 1 generation backK981141 Sargon Immediate Load Implant, Model DSargon Ent., Inc. · 1999
- This deviceK152188 QUAD Dental Implants and ProsthesesDentack Impants, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK180859 PYRAMIDION Dental Implants and ProsthesesDentack Implants, Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K180859PYRAMIDION Dental Implants and ProsthesesDentack Implants, Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930071 | Sargon Cylindro-Blade Implant | Sargon Ent., Inc. | 1994 | — |
| −1 | K981141 | Sargon Immediate Load Implant, Model D | Sargon Ent., Inc. | 1999 | — |
| 0 (this device) | K152188 | QUAD Dental Implants and Prostheses | Dentack Impants, Ltd. | 2016 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 |
|---|---|---|---|
| * | K981141 | Sargon Immediate Load Implant, Model DSummary page 5…lowing Predicate Devices (primary and secondary): 3.1 Primary Predicate Device: Sargon's Immediate Load Implant Model D; cleared under 510(k) number K981141 on June 23, 1999. 3.2 Reference Predicate Device: Biomet's Biomet 3i Dental Abutments and Restorative Compone… | 1999 |
| † | K072642 | Biomet 3I Dental Abutments and Restorative Components | 2007 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K131097 | LEGACY3 6MM Length Implants | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180859 | PYRAMIDION Dental Implants and Prostheses | 2018 | 0 |
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 22 years and passes through 2 companies; a new generation was cleared every 16.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K180859 (Dentack Implants, Ltd., 2018) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K981141.
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?
DenTack QUAD 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 delayed loading or immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152188: QUAD Dental Implants and Prostheses.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152188
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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