510(k) · Cleared
Recalled · Class II · 2019Paltop Dental 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 Apr 20, 2012 as substantially equivalent to K063364 (Alpha-Bio Tec, Ltd., 2007) and 5 other predicates after a 207-day review. Its family tree reaches back 11 generations to 1996. 11 later devices descend from it. It has been recalled 5 times.
- Decided
- Apr 20, 2012
- Review
- 207 days
- Class
- Class II
- Product code
- DZE
- Recalls
- 5
- Predicates
- 6
Its longest line of descent runs back 11 generations to K960026 (1996). 90 ancestors in all, the oldest K874590 (1988). 11 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 7 generations between
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- This deviceK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012
- Descendant · cites it directly · 8 of its ownK130462 Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 5 of its ownK210117 Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. · 2021
- Descendant · 3 generations on · 2 of its ownK220200 Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK231395 INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023
- Descendant · 2 generations on · 1 of its ownK190849 IS-III active System_S-narrow TypeNeobiotech Co., Ltd. · 2019
Show all 11 generations
- Root · 11 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 10 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 9 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 8 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 7 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 6 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 5 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 4 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 3 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 2 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 1 generation backK071803 Ards Dental ImplantsArds, Ltd. · 2008
- This deviceK112795 Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2012
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd. · 2013 · cites it directly8descendants
- K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd. · 2021 · 2 generations on5descendants
- K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd. · 2022 · 3 generations on2descendants
- K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd. · 2023 · 3 generations on1descendant
- K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −10 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −9 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −8 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −7 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −6 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −5 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −4 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −3 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −2 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −1 | K071803 | Ards Dental Implants | Ards, Ltd. | 2008 | — |
| 0 (this device) | K112795 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2012 | — |
| +1 | K130462 | Paltop Narrow Implant, Paltop Short Implant | Paltop Advanced Dental Solutions, Ltd. | 2013 | 1 |
| +2 | K210117 | Paltop Narrow Implant | Paltop Advanced Dental Solutions, Ltd. | 2021 | — |
| +3 | K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions, Ltd. | 2022 | — |
| +3 | K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | 2023 | — |
| +2 | K190849 | IS-III active System_S-narrow Type | Neobiotech Co., Ltd. | 2019 | — |
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 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K063364 | Alpha Bio Dental Implant SystemSummary page 1…872.3640 5.11 Review Panel: Dental Device Panel 5.12 Predicate Devices: * Alpha-Rio Tece Dental Implant System (Alpha Bio Tec Ltd.) cleared under K063364; product code DZE (Implant, Endlosseous, Root-form). * MIS Dental Implant System (MIS - Implant Technologies Ltd.) clea… | 2007 |
| * | K040807 | Mis Dental Implant SystemSummary page 1…ec Ltd.) cleared under K063364; product code DZE (Implant, Endlosseous, Root-form). * MIS Dental Implant System (MIS - Implant Technologies Ltd.) cleared under K040807; product code DZE (Implant, Endosseous, Root-form). 10d6 3jou (0 M'e TOP… | 2004 |
| * | K080156 | Osseospeed TM Profile SystemSummary page 2…(Implant, Endosseous, Root-form). 10d6 3jou (0 M'e TOP * Osseospeed TM Profile System (ASTRA Tech AB) cleared under K(080156, K(091239); product code DZE (Implant, Endosseous, Root-Form) * ARSD Dental Implants (ARDS Ltd.) cleared under K(071803 ;… | 2008 |
| * | K091239 | Astra Tech Implant SystemSummary page 2…Endosseous, Root-form). 10d6 3jou (0 M'e TOP * Osseospeed TM Profile System (ASTRA Tech AB) cleared under K(080156, K(091239); product code DZE (Implant, Endosseous, Root-Form) * ARSD Dental Implants (ARDS Ltd.) cleared under K(071803 ;product co… | 2009 |
| * | K071803 | Ards Dental ImplantsSummary page 3…of operation and performance specification as the predicates Alpha-Rio Tec* Dental Implant System (KtJ63364), MIS Dental Implant System (K(040807), ARSD Dental Implants (K071803), OsseospeedTM Profile System (K(080156, K(091239) and NobleActive internal Connection Implant (K(071370).… | 2008 |
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 2…RDS Ltd.) cleared under K(071803 ;product code OZE (Implant, Endlosseous, Root-Form) *NobleActive internal Connection Implant (Nobel Biocare AB) cleared under K(071370; product code DZE (Implant, Endlosseous, Root-Form); product code NHA (Abutment, Implant, Dental, Endlosseous). 5.… | 2007 |
What descends from it? (11)
See all 113 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 |
|---|---|---|---|---|
| May 30, 2019 | Class II | Z-0019-2020 | Under Investigation by firm | Surface micro/nano topography on some of the implants contained within this lot may not be consistently present over the entire surface of the implant. |
| Feb 22, 2019 | Class II | Z-1064-2019 | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature |
| Feb 22, 2019 | Class II | Z-1061-2019 | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature |
| Feb 22, 2019 | Class II | Z-1062-2019 | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature |
| Feb 22, 2019 | Class II | Z-1063-2019 | Process control | Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 9 months on median.
- 11 of the 90 ancestors have a recall of any class.
- Of its descendants, K130462 (Paltop Advanced Dental Solutions, Ltd., 2013) has gone furthest, with 8 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. 2012, 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 Dental 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. The Paltop Dental Implant System 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/K112795 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112795: Paltop Dental 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/K112795
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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