Ditron Dental ULT-08420Recalls & reported problems
Ditron Dental Ltd · Ultimate Precision Implant Ø4.20mm L8mm · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Ditron Dental ULT-08420 is a root-form dental implant. The 28 reports all describe the implant failing to fuse with the surrounding bone, including some where that fusion was later lost; 28 injuries and no deaths were reported. No recalls name this device. Reports numbered 15 in the previous 12 months and none in the most recent 12 months.
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
- 28
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07290109280561), received between Apr 17, 2024 and Jul 28, 2025 — classified as 28 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (22 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate22
- Loss of Osseointegration6
Patient problems
- Inadequate Osseointegration27
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
InjuryJul 28, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
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 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 30, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJan 9, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 21109012 ↗InjuryJan 2, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 21052617 ↗InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 28, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 21, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 21, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 20742997 ↗InjuryOct 6, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjurySep 29, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 8, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 25, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 14, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2024Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, INSTABILITY OF THE IMPLANT.
Patient problems: Inadequate Osseointegration
MAUDE report 19717937 ↗InjuryJul 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
InjuryJul 11, 2024Failure to Osseointegrate; Failure to Osseointegrate
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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