510(k) · Cleared
ClearedPaltop Conical Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paltop Advanced Dental Solutions, Ltd. · DZE Implant, Endosseous, Root-Form
Cleared on May 25, 2022 as substantially equivalent to K210117 (Paltop Advanced Dental Solutions, Ltd., 2021) after a 121-day review. Its family tree reaches back 14 generations to 1996. 2 later devices descend from it.
- Decided
- May 25, 2022
- Review
- 121 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K960026 (1996). 95 ancestors in all, the oldest K874590 (1988). 2 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations between
- 3 generations backK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012 · Recalled
- 2 generations backK130462 Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013 · Recalled
- 1 generation backK210117 Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. · 2021
- This deviceK220200 Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK243983 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK232383 iPhysio® SystemEuroteknika · 2025
Show all 14 generations
- Root · 14 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 12 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 11 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 7 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 6 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 5 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 4 generations backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- 3 generations backK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012 · Recalled
- 2 generations backK130462 Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013 · Recalled
- 1 generation backK210117 Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. · 2021
- This deviceK220200 Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −13 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −12 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −7 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −6 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −5 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −4 | K071803 | Ards Dental Implants | Ards, Ltd. | 2008 | — |
| −3 | 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 |
| −1 | K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions, Ltd. | 2021 | — |
| 0 (this device) | K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions, Ltd. | 2022 | — |
| +1 | K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2025 | — |
| +1 | K232383 | iPhysio® System | Euroteknika | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 6 | 0 |
| 2001 | 10 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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.
What descends from it? (2)
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?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 13 of the 95 ancestors have a recall of any class.
- Of its descendants, K243983 (Paltop Advanced Dental Solutions, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K210117.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Paltop Conical Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Narrow diameter implants are intended for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots. The Paltop Conical Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220200 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220200: Paltop Conical Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220200
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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