Paltop 20-70002Recalls & reported problems
Paltop Advanced Dental Solutions Ltd · Advanced Dental Implant Ø3.75mm L11.5mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Paltop 20-70002 is a narrow dental implant screw used to anchor a replacement tooth in the jaw. The 57 reports mostly describe the implant failing to fuse with the surrounding bone, or losing that bond after it had formed, which can leave the implant loose. All 57 reports involve injuries, and there are no deaths. No recalls name this device. Reports rose sharply, from 2 in the earlier 12-month period to 55 in the most recent one.
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
- 55
- Deaths reported
- 0
- Injuries reported
- 55
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 07290108690019), received between Oct 20, 2025 and Sep 30, 2026 — classified as 55 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (48 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 Osseointegrate48
- Loss of Osseointegration7
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- Inadequate Osseointegration2
- Unspecified Infection1
Recent adverse event reports
The 25 most recent of 55 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 50942780 ↗InjurySep 29, 2026Loss of Osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930985 ↗InjuryAug 24, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50406086 ↗InjuryAug 24, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50406050 ↗InjuryAug 24, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50406027 ↗InjuryAug 24, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50406007 ↗InjuryAug 24, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50405980 ↗InjuryAug 24, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50405959 ↗InjuryAug 12, 2026Loss of Osseointegration
Loss of osseointegration
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50220568 ↗InjuryAug 5, 2026Failure to Osseointegrate
Failed to osseointegrate.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50140537 ↗InjuryJul 27, 2026Failure to Osseointegrate
Failure of osseointegration.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50005149 ↗InjuryJul 12, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25790382 ↗InjuryJul 5, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25712404 ↗InjuryJul 5, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25712398 ↗InjuryJul 1, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25676963 ↗InjuryJun 29, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25649004 ↗InjuryJun 29, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25648831 ↗InjuryJun 18, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25545231 ↗InjuryJun 18, 2026Failure to Osseointegrate
FAILURE OF OSSEOINTEGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25545215 ↗InjuryJun 10, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25459327 ↗InjuryJun 10, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25456910 ↗InjuryJun 9, 2026Failure to Osseointegrate
InjuryJun 9, 2026Failure to Osseointegrate
FAILED TO OSSEOINTEGRATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25443249 ↗InjuryJun 9, 2026Failure to Osseointegrate
InjuryJun 9, 2026Failure to Osseointegrate
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-1063-2019 · Feb 22, 2019 · TerminatedPaltop 1.25 Hex Drivers, Long Part Number: 60-70101
- 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
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