Paltop 21-70014Recalls & reported problems
Paltop Advanced Dental Solutions Ltd · Dynamic Dental Implant Ø5mm L11.5mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 22
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07290108695588), received between Oct 23, 2025 and Sep 27, 2026 — classified as 22 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (20 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 Osseointegrate20
- Loss of Osseointegration2
Patient problems
- Inadequate Osseointegration15
- No Clinical Signs, Symptoms or Conditions7
- Bruxism2
- Osteopenia/ Osteoporosis1
- Pain1
- Unspecified Infection1
Recent adverse event reports
The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.
InjurySep 27, 2026Failure to Osseointegrate
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 50909758 ↗InjuryAug 17, 2026Failure to Osseointegrate
InjuryAug 17, 2026Failure to Osseointegrate
InjuryJul 28, 2026Failure to Osseointegrate
InjuryJul 28, 2026Failure to Osseointegrate
InjuryJun 30, 2026Loss of Osseointegration
InjuryMay 17, 2026Failure to Osseointegrate
InjuryMay 7, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25110512 ↗InjuryMay 7, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25108726 ↗InjuryMay 4, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25064799 ↗InjuryApr 28, 2026Failure to Osseointegrate
InjuryApr 16, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24892829 ↗InjuryApr 15, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24881501 ↗InjuryApr 9, 2026Failure to Osseointegrate
InjuryFeb 11, 2026Failure to Osseointegrate
InjuryJan 27, 2026Loss of Osseointegration
InjuryJan 27, 2026Failure to Osseointegrate
InjuryJan 6, 2026Failure to Osseointegrate
InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 23469514 ↗InjuryNov 4, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: Bruxism; Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 23469442 ↗InjuryOct 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23400591 ↗InjuryOct 23, 2025Failure to Osseointegrate; Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23365053 ↗
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-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-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