FDA-Device2025-03-12Class II
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4544MP
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
16 units
Manufactured in
85 Ben Fairless Dr, Fairless Hills, PA, United States
Products
ET Rigid Abutment (Mini) SIze: 4.5D 4.0G/H 4.0H - Intended for use with a dental implant to provide support for prosthetic restorations such as crowns, bridges, or overdentures. Model/Catalog Number: ETRGA4544MP
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1273-2025Don't want to check this manually?
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