FDA-Device2016-12-28Class II
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Biomet 3i, LLC
Hazard
A limited number of product pouches may not have been sealed during packaging.
Sold states
Worldwide Distribution to Austria, Belgium, Switzerland, Germany, Spain, France, Great Britain, Ireland, Italy, Lithuania, Portugal and Sweden
Affected count
27
Manufactured in
4555 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
BIOMET 3i CERTAIN LOW PROFILE 30¿ ABUTMENT 3.4MM(D) X 5MM(H) An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0830-2017Don't want to check this manually?
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