510(k) · Cleared
ClearedSargon Cylindro-Blade Implant
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 Jul 8, 1994 after a 548-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1,047 later devices descend from it.
- Decided
- Jul 8, 1994
- Review
- 548 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 0
1,047 later devices descend from it, 5 citing it directly.
- This deviceK930071 Sargon Cylindro-Blade ImplantSargon Ent., Inc. · 1994
- Descendant · cites it directly · 1,043 of its ownK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- Descendant · cites it directly · 942 of its ownK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- Descendant · cites it directly · 735 of its ownK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 689 of its ownK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
Showing 5 of 1,047 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,047 · See all- K984104Iti Dental Implant SystemStraumann USA · 1999 · cites it directly1,043descendants
- K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Nobel Biocare Uas, Inc. · 2000 · cites it directly942descendants
- K992937Dental ImplantNobel Biocare Uas, Inc. · 2000 · cites it directly735descendants
- K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · 2 generations on689descendants
- K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004 · 3 generations on622descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K930071 | Sargon Cylindro-Blade Implant | Sargon Ent., Inc. | 1994 | — |
| +1 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| +1 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| +1 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| +2 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| +3 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 8 | 0 |
| 2004 | 13 | 0 |
| 2005 | 15 | 0 |
| 2006 | 22 | 0 |
| 2007 | 25 | 0 |
| 2008 | 37 | 0 |
| 2009 | 32 | 0 |
| 2010 | 27 | 0 |
| 2011 | 38 | 0 |
| 2012 | 39 | 0 |
| 2013 | 54 | 0 |
| 2014 | 48 | 0 |
| 2015 | 48 | 0 |
| 2016 | 53 | 0 |
| 2017 | 49 | 0 |
| 2018 | 50 | 0 |
| 2019 | 41 | 0 |
| 2020 | 73 | 0 |
| 2021 | 55 | 0 |
| 2022 | 60 | 0 |
| 2023 | 74 | 0 |
| 2024 | 77 | 0 |
| 2025 | 65 | 0 |
| 2026 | 33 | 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? (1,047)
See all 1,0475 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, K984104 (Straumann USA, 1999) has gone furthest, with 1,043 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/K930071 · printed Nov 4, 2026
Cite this page
510(k) Report. “K930071: Sargon Cylindro-Blade Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K930071
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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