510(k) · Cleared
Recalled · Class II · 2019Paltop Narrow Implant, Paltop Short 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 Aug 27, 2013 as substantially equivalent to K112795 (Paltop Advanced Dental Solutions, Ltd., 2012) and 2 other predicates after a 186-day review. Its family tree reaches back 12 generations to 1996. 8 later devices descend from it. It has been recalled once.
- Decided
- Aug 27, 2013
- Review
- 186 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 12 generations to K960026 (1996). 93 ancestors in all, the oldest K874590 (1988). 8 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 8 generations between
- 3 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 2 generations backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- 1 generation backK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012 · Recalled
- This deviceK130462 Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013
- Descendant · cites it directly · 5 of its ownK210117 Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK220200 Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2022
- Descendant · 2 generations on · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK190849 IS-III active System_S-narrow TypeNeobiotech Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK251605 DIMPLO Implant SystemDIMPLO, Ltd. · 2025
Show all 12 generations
- Root · 12 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 11 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 10 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 9 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 8 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 5 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 4 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 3 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 2 generations backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- 1 generation backK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012 · Recalled
- This deviceK130462 Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. · 2021 · cites it directly5descendants
- K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2022 · 2 generations on2descendants
- K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023 · 2 generations on1descendant
- K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd. · 2019 · cites it directly1descendant
- K251605DIMPLO Implant SystemDIMPLO, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −11 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −10 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −8 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −5 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −4 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −3 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −2 | K071803 | Ards Dental Implants | Ards, Ltd. | 2008 | — |
| −1 | K112795 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2012 | 5 |
| 0 (this device) | K130462 | Paltop Narrow Implant, Paltop Short Implant | Paltop Advanced Dental Solutions, Ltd. | 2013 | — |
| +1 | K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions, Ltd. | 2021 | — |
| +2 | K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions, Ltd. | 2022 | — |
| +2 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| +1 | K190849 | IS-III active System_S-narrow Type | Neobiotech Co., Ltd. | 2019 | — |
| +2 | K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 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 |
|---|---|---|
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K112795 | Paltop Dental Implant SystemSummary page 2…Solutions Ltd. ?V;(6 gu to 16e 'TOP " Paltop Dental Implant System (Paltop Advanced Dental Solutions Ltd.) cleared under K(112795; product code DZE, NHA (Implant, Endlosseous, Root-Form). * UINO Narrow Implant (MIS - Implant Technologies Ltd.) cleared un… | 2012 |
| * | K092555 | Uno Narrow ImplantSummary page 2…Ltd.) cleared under K(112795; product code DZE, NHA (Implant, Endlosseous, Root-Form). * UINO Narrow Implant (MIS - Implant Technologies Ltd.) cleared under K092555; product code DZE, NHA (Implant, Endlosseous, Root-Form). * Osseospeed TmNarrow (ASTRA Tech AR) cleared under K(0803… | 2010 |
| * | K080396 | Osseospeed NarrowSummary page 2…ant Technologies Ltd.) cleared under K092555; product code DZE, NHA (Implant, Endlosseous, Root-Form). * Osseospeed TmNarrow (ASTRA Tech AR) cleared under K(080396; product code DZE,NHA (Implant, Endlosseous, Root-Form) intended Use /Indication for Use: The Paltop Narrow Implant is… | 2008 |
What descends from it? (8)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2019 | Class II | Z-0836-2020 | Mixed-up of materials/components | Some of the implants were packaged with a Standard Platform Cover Screw instead of a Narrow Platform Cover Screw. The Standard Platform Cover Screw will not fit in the Narrow Platform implant. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 12 of the 93 ancestors have a recall of any class.
- Of its descendants, K210117 (Paltop Advanced Dental Solutions, Ltd., 2021) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K112795.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 edlentulous 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/K130462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130462: Paltop Narrow Implant, Paltop Short Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130462
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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