MAUDE manufacturer profile

DENTSPLY DETREY GMBH · EMA

MAUDE profile for Cement, Dental

Key facts

Manufacturer DENTSPLY DETREY GMBH
Manufacturer group DENTSPLY DETREY GMBH
Product code EMA
Product code name Cement, Dental

At a glance

  • 10–99 MAUDE reports
  • 10–99 Injury reports
  • 1–9 Problems flagged by Orca1 signal analytics
  • Patient-Device Incompatibility, Hypersensitivity/Allergic reaction, Adverse Event Without Identified Device or Use Problem, Reaction, Insufficient Information, Failure of Implant, No Clinical Signs, Symptoms or Conditions, Loss of or Failure to Bond Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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