Dentsply Ih Inc.
590 LINCOLN STREET, Waltham, MA, US
Registered product codes
5 product codes
Recent MDR events
295 on file
- Atlantis Abutment TiJul 31, 2026Injury1222802-2026-00220
- S Atlantis Abutm Goldshaded TiJul 31, 2026Injury1222802-2026-00221
- S Atlantis Abutment TiJul 31, 2026Injury1222802-2026-00222
- Atlantis IO FLO IO-P-04Jul 30, 2026Injury1222802-2026-00215
- Atlantis Abutment TiJul 30, 2026Injury1222802-2026-00216
- S Atlantis Abutment TiJul 30, 2026Injury1222802-2026-00217
- Atlantis Abutment Zr 00Jul 30, 2026Injury1222802-2026-00218
- S Atlantis Abutment TiJul 30, 2026Injury1222802-2026-00219
- S Atlantis Abutment TiJul 29, 2026Injury1222802-2026-00207
- Atlantis Abutment TiJul 29, 2026Injury1222802-2026-00208
Recalls
2 on file
- Open, ClassifiedAug 25, 2025
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
View FDA record ↗ - Open, ClassifiedAug 25, 2025
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
View FDA record ↗
Compliance history
Matched by FEI 1000120733.
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.