510(k) · Cleared
ClearedArds Dental Implants
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ards, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on Sep 5, 2008 as substantially equivalent to K063364 (Alpha-Bio Tec, Ltd., 2007) after a 431-day review. Its family tree reaches back 10 generations to 1996. 13 later devices descend from it.
- Decided
- Sep 5, 2008
- Review
- 431 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K960026 (1996). 76 ancestors in all, the oldest K874590 (1988). 13 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 6 generations between
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 1 generation backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- This deviceK071803 Ards Dental ImplantsArds, Ltd. · 2008
- Descendant · cites it directly · 11 of its ownK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012 · Recalled
- Descendant · 2 generations on · 8 of its ownK130462 Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013 · Recalled
- Descendant · 3 generations on · 5 of its ownK210117 Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. · 2021
- Descendant · 4 generations on · 2 of its ownK220200 Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2022
- Descendant · 4 generations on · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
Show all 10 generations
- Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 8 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 7 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 4 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 3 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 2 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 1 generation backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- This deviceK071803 Ards Dental ImplantsArds, Ltd. · 2008
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012 · cites it directly11descendants
- K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013 · 2 generations on8descendants
- K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. · 2021 · 3 generations on5descendants
- K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2022 · 4 generations on2descendants
- K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −9 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −7 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −4 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −3 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −2 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −1 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| 0 (this device) | K071803 | Ards Dental Implants | Ards, Ltd. | 2008 | — |
| +1 | K112795 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2012 | 5 |
| +2 | K130462 | Paltop Narrow Implant, Paltop Short Implant | Paltop Advanced Dental Solutions, Ltd. | 2013 | 1 |
| +3 | K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions, Ltd. | 2021 | — |
| +4 | K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions, Ltd. | 2022 | — |
| +4 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 8 | 0 |
| 2003 | 7 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K063364 | Alpha Bio Dental Implant SystemSummary page 4…3-969-0954 Dr. Uri Arny, CEO March 7, 2008 Endosseous Dental Implant, Class 2, Product Code DZE, 21 CFR 872.3640 ARDS Dental implants Alpha Bio Dental Implant System (K063364) ARDS implants are made from Titanium alloy. The ARDS implants geometrical shape is characterized by altering drilling profile,… | 2007 |
What descends from it? (13)
See all 132 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 7 of the 76 ancestors have a recall of any class.
- Of its descendants, K112795 (Paltop Advanced Dental Solutions, Ltd., 2012) has gone furthest, with 11 descendants of its own.
- 12 other devices also cite its predicate K063364.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
ARDS dental implants are indicated for use in surgical and restorative applications for placement in the bone of the upper and lower jaw to provide support for prosthetic devices in order to restore the patient's chewing function. ARDS dental implants are indicated for two-stage surgery.
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/K071803 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071803: Ards Dental Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071803
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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