Device product
ET Rigid Abutment (Mini) Size 4.5D 1.0G/H 5.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. GA4515MP Model/Catalog Number: ETRGA4515MP
Z-1271-2025
Product summary
- Firm
- Hiossen Inc.
- Event
- Event 96178
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 48
- Official record key
device-enforcement:Z-1271-2025
Official wording
Reason: Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version
Code information: UDI-DI: 00814913026350 Lot# H4E20K117
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version