Device product
Osstem Implant System - Abutment ET Multi Abutment Size: 4.8D 3.0G/H- Abutment is intended for use with a dental implant to provide suport for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETMTA503RV1
Z-1274-2025
Product summary
- Firm
- Hiossen Inc.
- Event
- Event 96178
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19 units
- Official record key
device-enforcement:Z-1274-2025
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: 00810019241529 Lot# H4E21D092
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