Device product
ET Rigid Abutment (Mini) SIze: 4.5D 3.0G/H 7.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4537MP
Z-1272-2025
Product summary
- Firm
- Hiossen Inc.
- Event
- Event 96178
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19
- Official record key
device-enforcement:Z-1272-2025
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: Lot Code: UDI-DI: 00814913026428 Lot# H4E20L088
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