Paltop 20-70007Recalls & reported problems
Paltop Advanced Dental Solutions Ltd · Advanced Dental Implant Ø4.2mm L10mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Paltop 4.2mm dental implant is a screw-like root-form implant used to anchor a replacement tooth in the jawbone. The 37 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that bond after it had formed, along with a few cases of infection and implant pain. All 37 reports describe injuries and no deaths, and no recalls name this device. Reports of this problem rose sharply, from 4 in the previous 12 months to 33.
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
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 07290108690064), received between Oct 23, 2025 and Sep 30, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (31 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 Osseointegrate31
- Loss of Osseointegration7
Patient problems
- No Clinical Signs, Symptoms or Conditions36
- Inadequate Osseointegration2
- Unspecified Infection2
- Implant Pain1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Loss of Osseointegration
Loss of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50942629 ↗InjurySep 29, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930818 ↗InjuryAug 3, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111286 ↗InjuryJul 15, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25822201 ↗InjuryJun 28, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25647553 ↗InjuryJun 24, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25606286 ↗InjuryJun 24, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25604103 ↗InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 8, 2026Failure to Osseointegrate
InjuryJun 7, 2026Failure to Osseointegrate
InjuryJun 4, 2026Failure to Osseointegrate
InjuryJun 4, 2026Failure to Osseointegrate
InjuryJun 2, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25357802 ↗InjuryJun 2, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25357184 ↗InjuryMay 27, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25297411 ↗InjuryMay 20, 2026Failure to Osseointegrate
InjuryMay 18, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197338 ↗InjuryMay 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197320 ↗InjuryMay 18, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197306 ↗InjuryMay 18, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197294 ↗InjuryMay 14, 2026Failure to Osseointegrate
FAILED TO OSSEO.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 25170315 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159233 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157152 ↗InjuryMay 11, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134262 ↗InjuryMay 10, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133256 ↗
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-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-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-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.
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