CeraRoot Implant System 120.012Recalls & reported problems
Ceraroot Sl. · Implant CeraRoot 12:12/4.1 Size L= 12mm Indicated for UPPER LATERAL INCISORS AND LOWER INCISORS One-piece zirconia dental Implant including abutment. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08435453900232), received between May 20, 2021 and May 20, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (1 report).
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.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Stomatitis1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 20, 2021Use of Device Problem; Use of Device Problem
THE CLINICIAN REPORTED THAT INFECTION WAS DEVELOPED 7 DAYS POST SURGERY, THE DENTAL IMPLANT WAS REMOVED, AND ANTIBIOTIC WAS PRESCRIBED. DURING THE DENTAL IMPLANT PLACEMENT SURGERY THE IMPLANT WAS PLACED IMMEDIATELY AFTER TOOTH EXTRACTION IN THE SAME INTERVENTION. ANTIBIOTIC WAS NOT PRESCRIBED THE DAY OF SURGERY. PATIENT WAS HOSPITALIZED UNTIL INFECTION WAS RESOLVED AND THE PATIENT RETURNED HOME WITHOUT ANY FURTHER PROBLEMS, INJURIES OR COMPLICATIONS. THE IMPLANT SITE WILL BE LET TO HEAL UNTIL A NEW IMPLANT CAN BE INSERTED.
Patient problems: Stomatitis
MAUDE report 11853819 ↗
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- 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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