Paltop 21-70002Recalls & reported problems
Paltop Advanced Dental Solutions Ltd · Dynamic Dental Implant Ø3.75mm L11.5mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Paltop Dynamic dental implant is a screw placed in the jawbone to hold a replacement tooth. The 78 reports list 78 injuries and no deaths. Nearly all describe the implant failing to fuse with the bone or losing that bond, and a few report pain or infection. Reports rose to 68 in the last 12 months from 10 in the prior 12 months. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 78
- Deaths reported
- 0
- Injuries reported
- 78
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 78 adverse event reports that list this exact device (DI 07290108695465), received between Oct 12, 2025 and Aug 16, 2026 — classified as 78 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (64 reports).
5 other recalls cover devices cleared under the same FDA submission (K112795); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate64
- Loss of Osseointegration13
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Inadequate Osseointegration25
- Pain8
- Unspecified Infection3
- Bruxism1
- Inflammation1
Recent adverse event reports
The 25 most recent of 78 reports, in the reporter's own words as published by the FDA.
InjuryAug 16, 2026Loss of Osseointegration
InjuryJul 28, 2026Failure to Osseointegrate
InjuryJul 27, 2026
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50032839 ↗InjuryJul 14, 2026Failure to Osseointegrate
InjuryJul 6, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25714117 ↗InjuryJul 6, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25713402 ↗InjuryJun 25, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25617713 ↗InjuryJun 24, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25604576 ↗InjuryJun 22, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25573601 ↗InjuryJun 22, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25573488 ↗InjuryJun 7, 2026Loss of Osseointegration
InjuryMay 31, 2026Failure to Osseointegrate
InjuryMay 31, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Inadequate Osseointegration; Pain; Unspecified Infection
MAUDE report 25344552 ↗InjuryMay 19, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25212438 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25158968 ↗InjuryMay 10, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133267 ↗InjuryMay 6, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25092222 ↗InjuryMay 4, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25065196 ↗InjuryApr 27, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24997161 ↗InjuryApr 27, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24996100 ↗InjuryApr 27, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994716 ↗InjuryApr 19, 2026Failure to Osseointegrate
InjuryApr 19, 2026Failure to Osseointegrate
InjuryApr 19, 2026Failure to Osseointegrate
InjuryApr 15, 2026Loss of Osseointegration
Recalls under the same FDA submission
These recalls involve devices cleared under K112795. One submission often covers many models, so check the product and lot details in each record.
- Z-0019-2020 · May 30, 2019 · TerminatedPaltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
- Z-1061-2019 · Feb 22, 2019 · TerminatedPaltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112
- Z-1062-2019 · Feb 22, 2019 · TerminatedPaltop Fully Guided Surgical Kit- containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 30-70021
- Z-1064-2019 · Feb 22, 2019 · TerminatedPaltop 1.25 Hex Drivers, Short Part Number: 60-70102
- Z-1063-2019 · Feb 22, 2019 · TerminatedPaltop 1.25 Hex Drivers, Long Part Number: 60-70101
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page