510(k) · Cleared
ClearedSargon Immediate Load Implant, Model D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sargon Ent., Inc. · DZE Implant, Endosseous, Root-Form
Cleared on Jun 23, 1999 as substantially equivalent to K930071 (Sargon Ent., Inc., 1994) and 1 other predicate after a 450-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Jun 23, 1999
- Review
- 450 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K930071 (1994). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK930071 Sargon Cylindro-Blade ImplantSargon Ent., Inc. · 1994
- This deviceK981141 Sargon Immediate Load Implant, Model DSargon Ent., Inc. · 1999
- Descendant · cites it directly · 1 of its ownK152188 QUAD Dental Implants and ProsthesesDentack Impants, Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK180859 PYRAMIDION Dental Implants and ProsthesesDentack Implants, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK082573 Sargon Non-Expandable Dental ImplantSargon Ent., Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K152188QUAD Dental Implants and ProsthesesDentack Impants, Ltd. · 2016 · cites it directly1descendant
- K180859PYRAMIDION Dental Implants and ProsthesesDentack Implants, Ltd. · 2018 · 2 generations on0descendants
- K082573Sargon Non-Expandable Dental ImplantSargon Ent., Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K930071 | Sargon Cylindro-Blade Implant | Sargon Ent., Inc. | 1994 | — |
| 0 (this device) | K981141 | Sargon Immediate Load Implant, Model D | Sargon Ent., Inc. | 1999 | — |
| +1 | K152188 | QUAD Dental Implants and Prostheses | Dentack Impants, Ltd. | 2016 | — |
| +2 | K180859 | PYRAMIDION Dental Implants and Prostheses | Dentack Implants, Ltd. | 2018 | — |
| +1 | K082573 | Sargon Non-Expandable Dental Implant | Sargon Ent., Inc. | 2010 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K930071 | Sargon Cylindro-Blade ImplantSummary page 1…attachment; trade name: Sargon Immediate Load Implant™. |t is substantially equivalent to previously marketed models of this device described in premarket notifications K930071 and K961005. In this design, the collar is longer and allows the direct fixation of a prosthesis to the implant with or without t… | 1994 |
| * | K961005 | Sargon Immediate Load ImplantSummary page 1…trade name: Sargon Immediate Load Implant™. |t is substantially equivalent to previously marketed models of this device described in premarket notifications K930071 and K961005. In this design, the collar is longer and allows the direct fixation of a prosthesis to the implant with or without the use of an… | 1996 |
What descends from it? (3)
2 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.
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?
For immediate load use, without an abutment, in either partially or fully edentulous mandibles and maxillae, for fixed or detachable prosthesis and for use in support of free-standing restorations with or without the involvement of adjacent dentition.
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/K981141 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981141: Sargon Immediate Load Implant, Model D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981141
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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