Paltop 20-70017Recalls & reported problems
Paltop Advanced Dental Solutions Ltd · Advanced Dental Implant Ø3.75mm L8mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 07290108690163), received between Oct 23, 2025 and Aug 6, 2026 — classified as 19 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (16 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 Osseointegrate16
- Loss of Osseointegration3
Patient problems
- No Clinical Signs, Symptoms or Conditions19
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50152805 ↗InjuryJun 21, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25572118 ↗InjuryJun 18, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25544883 ↗InjuryJun 9, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25442131 ↗InjuryMay 26, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25276287 ↗InjuryMay 24, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25266810 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25159029 ↗InjuryMay 13, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25157074 ↗InjuryApr 29, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034146 ↗InjuryApr 29, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25030191 ↗InjuryApr 28, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25012151 ↗InjuryApr 28, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25011403 ↗InjuryApr 27, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994565 ↗InjuryApr 27, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24994246 ↗InjuryApr 16, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24894112 ↗InjuryApr 15, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24882956 ↗InjuryJan 25, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24175499 ↗InjuryOct 26, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23387934 ↗InjuryOct 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23364869 ↗
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-1063-2019 · Feb 22, 2019 · TerminatedPaltop 1.25 Hex Drivers, Long Part Number: 60-70101
- Z-1064-2019 · Feb 22, 2019 · TerminatedPaltop 1.25 Hex Drivers, Short Part Number: 60-70102
- 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-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
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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