Ditron Dental ULT-13420Recalls & reported problems
Ditron Dental Ltd · Ultimate Precision Implant Ø4.20mm L13mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 15
- Deaths reported
- 0
- Injuries reported
- 15
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07290109280684), received between Jul 14, 2024 and Jan 30, 2025 — classified as 15 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (8 reports).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate8
- Loss of Osseointegration7
Patient problems
- Inadequate Osseointegration15
- Unspecified Infection1
Recent adverse event reports
The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.
InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 2, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 21052649 ↗InjuryDec 12, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20911159 ↗InjuryDec 12, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryDec 12, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20910827 ↗InjuryNov 28, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20804093 ↗InjuryOct 13, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT. INFECTION.
Patient problems: Inadequate Osseointegration; Unspecified Infection
MAUDE report 20435807 ↗InjuryOct 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryOct 6, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20379679 ↗InjuryOct 6, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20379678 ↗InjuryJul 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
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- 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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