510(k) · Cleared
ClearedPaltop Short Implants
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 22, 2024 as substantially equivalent to K172576 (BioHorizons Implant Systems, Inc., 2017) after a 258-day review. Its family tree reaches back 3 generations to 2007.
- Decided
- May 22, 2024
- Review
- 258 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K071638 (2007). No later device cites it as a predicate yet.
- Root · 3 generations backK071638 Biohorizons Tapered Internal Implant SystemBioHorizons Implant Systems, Inc. · 2007 · Recalled
- 2 generations backK121787 Biohorizons Tapered Internal Plus ImplantsBioHorizons Implant Systems, Inc. · 2012
- 1 generation backK172576 BioHorizons Tapered Short ImplantsBioHorizons Implant Systems, Inc. · 2017
- This deviceK232740 Paltop Short ImplantsPaltop Advanced Dental Solutions, Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K071638 | Biohorizons Tapered Internal Implant System | BioHorizons Implant Systems, Inc. | 2007 | 2 |
| −2 | K121787 | Biohorizons Tapered Internal Plus Implants | BioHorizons Implant Systems, Inc. | 2012 | — |
| −1 | K172576 | BioHorizons Tapered Short Implants | BioHorizons Implant Systems, Inc. | 2017 | — |
| 0 (this device) | K232740 | Paltop Short Implants | Paltop Advanced Dental Solutions, Ltd. | 2024 | — |
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 |
|---|---|---|---|
| * | K172576 | BioHorizons Tapered Short ImplantsSummary page 5…llowing legally marketed primary predicate device: 510(k) Primary Predicate Device Name Company Name K172576 BioHorizons Tapered Short Implants BioHorizons Implant System, Inc. Reference devices were… | 2017 |
| † | K103089 | Seven Implants; Biocom Implants; Lance Implants | 2011 |
| † | K092035 | Bicon Implants with a 2.5MM Internal Connection | 2009 |
| † | K210117 | Paltop Narrow Implant | 2021 |
| † | K220200 | Paltop Conical Implant System | 2022 |
| † | K112795 | Paltop Dental Implant System | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 17 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 2 other devices also cite its predicate K172576.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Paltop Short Implants (Internal Hex and Conical Connections) are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw as an artificial root structure for single tooth replacement or for fixed bridgework to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient’s chewing function. Paltop Short Implants are indicated to be used only with straight abutments and are for delayed loading only.
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/K232740 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232740: Paltop Short Implants.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232740
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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