510(k) · Cleared
ClearedSargon Non-Expandable Dental 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 21, 2010 as substantially equivalent to K012757 (Straumann USA, 2001) and 5 other predicates after a 684-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Jul 21, 2010
- Review
- 684 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K894595 (1990). 37 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.
- Root · 7 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 5 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 4 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 3 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 2 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 1 generation backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- This deviceK082573 Sargon Non-Expandable Dental ImplantSargon Ent., Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −6 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −5 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −4 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −3 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −2 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −1 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| 0 (this device) | K082573 | Sargon Non-Expandable Dental Implant | Sargon Ent., Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 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? (6)
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 |
|---|---|---|---|
| * | K012757 | Iti Dental Implant SystemSummary page 1…Endosseous dental implant Classification Name: Endosseous dental implant 3. Substantial Equivalence: Strauman ITI (K012757, K003271 and K033984) Sargon implants (K(930071, K961005 and K981141) 4. Description of the Device… | 2001 |
| * | K003271 | Modification to Iti Dental Implant SystemSummary page 1…Endosseous dental implant Classification Name: Endosseous dental implant 3. Substantial Equivalence: Strauman ITI (K012757, K003271 and K033984) Sargon implants (K(930071, K961005 and K981141) 4. Description of the Device… | 2001 |
| * | K033984 | Straumann Dental Implant SystemSummary page 1…ental implant Classification Name: Endosseous dental implant 3. Substantial Equivalence: Strauman ITI (K012757, K003271 and K033984) Sargon implants (K(930071, K961005 and K981141) 4. Description of the Device… | 2004 |
| * | K930071 | Sargon Cylindro-Blade ImplantSummary page 1…Endosseous dental implant 3. Substantial Equivalence: Strauman ITI (K012757, K003271 and K033984) Sargon implants (K(930071, K961005 and K981141) 4. Description of the Device… | 1994 |
| * | K961005 | Sargon Immediate Load ImplantSummary page 1…Endosseous dental implant 3. Substantial Equivalence: Strauman ITI (K012757, K003271 and K033984) Sargon implants (K(930071, K961005 and K981141) 4. Description of the Device… | 1996 |
| * | K981141 | Sargon Immediate Load Implant, Model DSummary page 1…sseous dental implant 3. Substantial Equivalence: Strauman ITI (K012757, K003271 and K033984) Sargon implants (K(930071, K961005 and K981141) 4. Description of the Device implant… | 1999 |
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 20 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 37 ancestors have a recall of any class.
- 10 other devices also cite its predicate K012757.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The Sargon Non-Expandable Dental Implant is indicated for immediate placement or delayed placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in partially or fully edentulous patients and to restore the patient's chewing function. This device is not indicated for immediate loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082573 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082573: Sargon Non-Expandable Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082573
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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