510(k) · Cleared
ClearedSargon Immediate Load Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graham & James · DZE Implant, Endosseous, Root-Form
Cleared on May 6, 1996 after a 55-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- May 6, 1996
- Review
- 55 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK961005 Sargon Immediate Load ImplantGraham & James · 1996
- Descendant · cites it directly · 3 of its ownK981141 Sargon Immediate Load Implant, Model DSargon Ent., Inc. · 1999
- Descendant · 2 generations on · 1 of its ownK152188 QUAD Dental Implants and ProsthesesDentack Impants, Ltd. · 2016
- Descendant · 3 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 4 of 4 · See all- K981141Sargon Immediate Load Implant, Model DSargon Ent., Inc. · 1999 · cites it directly3descendants
- K152188QUAD Dental Implants and ProsthesesDentack Impants, Ltd. · 2016 · 2 generations on1descendant
- K180859PYRAMIDION Dental Implants and ProsthesesDentack Implants, Ltd. · 2018 · 3 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 |
|---|---|---|---|---|---|
| 0 (this device) | K961005 | Sargon Immediate Load Implant | Graham & James | 1996 | — |
| +1 | K981141 | Sargon Immediate Load Implant, Model D | Sargon Ent., Inc. | 1999 | — |
| +2 | K152188 | QUAD Dental Implants and Prostheses | Dentack Impants, Ltd. | 2016 | — |
| +3 | K180859 | PYRAMIDION Dental Implants and Prostheses | Dentack Implants, Ltd. | 2018 | — |
| +1 | K082573 | Sargon Non-Expandable Dental Implant | Sargon Ent., Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K981141 (Sargon Ent., Inc., 1999) has gone furthest, with 3 descendants of its own.
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 | — |
https://510kreport.com/device/K961005 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961005: Sargon Immediate Load Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961005
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026