MalfunctionEBI
TRUEDENT
Received Jul 8, 2025 · Event occurred Jun 30, 2025
Report 3016074824-2025-00034 · MDR key 22434795
Device
Generic name
Truedent
Manufacturer
Stratasys Ltd.Product problems
- Biocompatibility
- Biocompatibility
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
POLISHED TRUEDENT DENTURES WERE SENT BY A POTENTIAL CUSTOMER FOR CYTOTOXICITY TEST AND THEY DID NOT PASS THE TEST. THE CYTO TESTS WERE PERFORMED ON THE POLISHED DENTURES THAT WERE PRINTED AND POLISHED AT STRATASYS.