Straumann Variobase Abutment / IPS e.max CAD restorations Final AbutmentsRecalls & reported problems
Institut Straumann AG · RC Variobase® for Crown, incl. screw, Ø 4.5mm, AH 3.5mm, GH 2mm, TAN · 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 07630031736208), received between Oct 20, 2021 and Oct 20, 2021 — classified as 1 injury.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Skin Discoloration1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 20, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
WE HAVE BEEN INFORMED BY THE CLINICIAN ON 02.08.2021, A LOCALIZED DISCOLOURATION OF GINGIVA AFTER FULL RESTORATION OF THE DENTAL IMPLANT (RESTORATION PLACEMENT ON (B)(6) 2020) LEADING TO LOCALIZED GINGIVA REMOVAL AND AUGMENTATION AND REVISION OF THE RESTORATION (REMOVAL ON (B)(6) 2021).
Patient problems: Skin Discoloration
MAUDE report 12666793 ↗
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- CERTAIN® IUNIHTZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS67 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Dentsply Ih, Inc. · Abutment, implant, dental, endosseous54 reports
- Esthetic Abutment 36669Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall2 reports
- CERTAIN® BELLATEK® IEDAT5ZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 recall1 report
- Custom Abutments Final AbutmentsInstitut Straumann AG · Abutment, implant, dental, endosseous1 recall0 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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