ATLANTIS® 35502 (UDI 07392532291616)Recalls & reported problems
Dentsply Ih, Inc. · ATLANTIS Abutment Ti · Class 2 · Implant
Quick summary
This DENTSPLY Atlantis titanium abutment is the connector piece used in dental implants. The 76 reports filed against it in the past year mostly describe metal components breaking — either the abutment itself or the implant it attaches to — sometimes separating or loosening, with a small number of allergic reactions.68 reports describe injuries, no deaths. Reports run from January 2026 to August 2026, and there were none in the previous 12 months. No recalls name this device.
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
- 54
- Deaths reported
- 0
- Injuries reported
- 45
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 54 adverse event reports that list this exact device (DI 07392532291616), received between Jan 20, 2026 and Sep 28, 2026 — classified as 45 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Fracture” (48 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
- Fracture48
- Separation Failure3
- Device Appears to Trigger Rejection1
- Loose or Intermittent Connection1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Failure of Implant11
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 25 most recent of 54 reports, in the reporter's own words as published by the FDA.
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 ↗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 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 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 50052480 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a dental abutment breakage.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052476 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a fracture of a dental screw in an EV 4.2 implant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052423 ↗InjuryJul 28, 2026Fracture
It was reported that a patient experienced a fracture of a dental screw during insertion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50052338 ↗MalfunctionJul 27, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50009752 ↗InjuryJun 3, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25372435 ↗InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25364896 ↗InjuryJun 2, 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 25364861 ↗InjuryJun 2, 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 25364844 ↗InjuryJun 2, 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 25364367 ↗InjuryJun 2, 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 25364130 ↗InjuryJun 2, 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 25361397 ↗InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25361385 ↗InjuryJun 2, 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 25360919 ↗InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360764 ↗InjuryJun 2, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360466 ↗InjuryJun 1, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355432 ↗InjuryJun 1, 2026Fracture
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL ABUTMENT BREAKAGE AND THE RESULTING FRAGMENT LED TO THE EXPLANTATION OF THE IMPLANT.
Patient problems: Failure of Implant
MAUDE report 25351088 ↗
Other Abutment, implant, dental, endosseous devices
- CERTAIN® GOLD-TITE® IUNIHGZimVie US Corp LLC · ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS151 reports
- 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
- 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
- Legacy™ SMARTbase, Narrow, NE 8745-80NNEImplant Direct Sybron Manufacturing LLC · 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.