ATLANTIS™ 35515Recalls & reported problems
Dentsply Ih, Inc. · ATLANTIS Abutment Zr 30 · Class 2 · Implant
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07392532177262), received between Dec 10, 2024 and Jun 2, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Fracture” (5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture5
- Failure to Osseointegrate1
Patient problems
- Failure of Implant3
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361315 ↗InjuryMay 29, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT ABUTMENT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25330285 ↗InjuryMay 28, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25322578 ↗InjuryMay 6, 2025Failure to Osseointegrate; Failure to Osseointegrate
IN THIS EVENT IT IS REPORTED THAT ATLANTIS ABUTMENT ZR 30 FRACTURED. THE FRAGMENT COULDN'T BE REMOVED, THAT LEADED TO IMPLANT EXPLANTATION.
Patient problems: Failure of Implant
MAUDE report 21970582 ↗InjuryDec 10, 2024Fracture; Fracture
ABUTMENTS WERE BROKEN, THE FRAGMENTS COULD NOT BE REMOVED AND THE DOCTOR EXPLANTED THE IMPLANTS. IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20891521 ↗InjuryDec 10, 2024Fracture; Fracture
ABUTMENTS WERE BROKEN, FRAGMENTS COULDN'T BE REMOVED AND THE DOCTOR EXPLANTED THE IMPLANTS. IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT LOSS.
Patient problems: Failure of Implant
MAUDE report 20891502 ↗
Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices
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- Nobel Biocare® 36662Nobel Biocare AB · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 recalls5 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.