510(k) · Cleared
ClearedPaltop Narrow Implant
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 Nov 30, 2021 as substantially equivalent to K130462 (Paltop Advanced Dental Solutions, Ltd., 2013) after a 315-day review. Its family tree reaches back 13 generations to 1996. 5 later devices descend from it.
- Decided
- Nov 30, 2021
- Review
- 315 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K960026 (1996). 94 ancestors in all, the oldest K874590 (1988). 5 later devices descend from it, 3 citing it directly.
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 9 generations between
- 3 generations backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- 2 generations backK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012 · Recalled
- 1 generation backK130462 Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013 · Recalled
- This deviceK210117 Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK220200 Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2022
- Descendant · cites it directly · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243983 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK232383 iPhysio® SystemEuroteknika · 2025
Show all 13 generations
- Root · 13 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 11 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 10 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 9 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 6 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 5 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 4 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 3 generations backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- 2 generations backK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012 · Recalled
- 1 generation backK130462 Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013 · Recalled
- This deviceK210117 Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2022 · cites it directly2descendants
- K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023 · cites it directly1descendant
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · cites it directly0descendants
- K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2025 · 2 generations on0descendants
- K232383iPhysio® SystemEuroteknika · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −12 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −11 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −9 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −6 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −5 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −4 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −3 | K071803 | Ards Dental Implants | Ards, Ltd. | 2008 | — |
| −2 | K112795 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2012 | 5 |
| −1 | K130462 | Paltop Narrow Implant, Paltop Short Implant | Paltop Advanced Dental Solutions, Ltd. | 2013 | 1 |
| 0 (this device) | K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions, Ltd. | 2021 | — |
| +1 | K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions, Ltd. | 2022 | — |
| +1 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| +1 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025 | — |
| +2 | K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2025 | — |
| +2 | 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 |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K130462 | Paltop Narrow Implant, Paltop Short ImplantSummary page 4…ign principles to the following predicate and reference devices: 510(k) Predicate Device Name Company Name K130462 Paltop Narrow Implant Paltop Advanced Dental Solutions R… | 2013 |
| † | K102436 | Nobel Active 3.0 | 2010 |
| † | K112795 | Paltop Dental Implant System | 2012 |
| † | K131451 | Paltop Dental Implant - Sterile Accessories | 2013 |
What descends from it? (5)
3 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 25 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 13 of the 94 ancestors have a recall of any class.
- Of its descendants, K220200 (Paltop Advanced Dental Solutions, Ltd., 2022) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K130462.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Narrow Implant is indicated for use in surgical and restorative applications 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, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also 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/K210117 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210117: Paltop Narrow Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210117
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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