FDA-Device2025-03-12Class II

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

Hiossen Inc.
Hazard

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

Sold states
US Nationwide distribution.
Affected count
19 units
Manufactured in
85 Ben Fairless Dr, Fairless Hills, PA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1274-2025

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