FEI 1036212Initial importer
Dentsply Sirona Orthodontics Inc.
7290 26th Court East, Sarasota, FL, US
MDR events287All time
Recalls0All time
Registered products19
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
19 product codes
Recent MDR events
287 on file
- NONTEMPLATE ALIGNER ARCHJul 31, 2026Malfunction1649995-2026-00049
- NONTEMPLATE ALIGNER ARCHJul 31, 2026Malfunction1649995-2026-00050
- NONTEMPLATE ALIGNER ARCHJul 30, 2026Malfunction1649995-2026-00048
- NONTEMPLATE ALIGNER ARCHJul 28, 2026Injury1649995-2026-00045
- NONTEMPLATE ALIGNER ARCHJul 28, 2026Injury1649995-2026-00046
- NONTEMPLATE ALIGNER ARCHJul 28, 2026Injury1649995-2026-00047
- NONTEMPLATE ALIGNER ARCHJul 27, 2026Injury1649995-2026-00044
- NONTEMPLATE ALIGNER ARCHJul 22, 2026Injury1649995-2026-00042
- SURESMILE RETAINERJul 22, 2026Injury1649995-2026-00043
- SURESMILE ALIGNER ARCHJul 17, 2026Malfunction1649995-2026-00041
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1036212.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.