ATLANTISRecalls & reported problems across all models
Dentsply Ih, Inc. · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 169
- Deaths reported
- 0
- Injuries reported
- 158
- Recalls
- 0
We found 10 models of ATLANTIS by Dentsply Ih, Inc. in the FDA's device registry (GUDID). Together they are named in 169 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2023 and Sep 30, 2026 — classified as 158 injuries, 11 malfunctions.
The most frequently reported specific device problem is “Fracture” (121 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported ATLANTIS problems
Device problems
- Fracture121
- Separation Failure36
- Failure to Osseointegrate7
- Product Quality Problem2
- Device Appears to Trigger Rejection1
- Difficult to Insert1
- Loose or Intermittent Connection1
- Loss of Osseointegration1
Patient problems
- Failure of Implant100
- No Clinical Signs, Symptoms or Conditions67
- Hypersensitivity/Allergic reaction1
- Inflammation1
- Laceration(s)1
- Pocket Erosion1
- Unspecified Infection1
ATLANTIS models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ATLANTIS® 35502ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS66 reports
- ATLANTIS® 35502Abutment, implant, dental, endosseous54 reports
- ATLANTIS® 35503ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS21 reports
- ATLANTIS® 35503Abutment, implant, dental, endosseous8 reports
- ATLANTIS™ 35511ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS6 reports
- ATLANTIS™ 35515ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS6 reports
- ATLANTIS™ 35501ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS4 reports
- Atlantis Atl BridgeBase Ti AMABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS2 reports
- ATLANTIS™ 35513ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
- Atlantis 36462ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS1 report
Recent ATLANTIS adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941511 ↗InjurySep 28, 2026Fracture
It was reported that a patient experienced an Abutment screw fracture.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916487 ↗MalfunctionSep 28, 2026Fracture
It was reported that a patient experienced a fracture of abutment on tooth 16.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913418 ↗MalfunctionSep 25, 2026Fracture
It was reported that the abutment on tooth 16 fractured.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899127 ↗InjurySep 22, 2026Fracture
It was reported that a patient experienced a fracture of a dental screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858763 ↗InjuryJul 30, 2026Loose or Intermittent Connection
It was reported that a patient accidentally swallowed an abutment on 07/04. No adverse health effects have been reported since the event. The patient was unable to confirm whether the abutment was expelled.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50090728 ↗InjuryJul 30, 2026Fracture
It was reported that the Atlantis abutment fractured, and the resulting fragment led to the explantation of the implant.
Patient problems: Failure of Implant
MAUDE report 50090515 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced breakage of dental abutments on teeth 45 and 46. The abutments fractured spontaneously.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052972 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced breakage of dental abutments on teeth 45 and 46. The abutments fractured spontaneously.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052971 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052929 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a fracture of a dental abutment screw.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052719 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052716 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052631 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052629 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052480 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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