FDA-Device2023-11-01Class II
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Preat Corp
Hazard
The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage
Sold states
US: FL, CA, OR, TX, OH, CA, SC, OR, NJ, SC, OUS: None
Affected count
13 units
Manufactured in
2625 Skyway Dr Ste B, N/A, Santa Maria, CA, United States
Products
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0152-2024Don't want to check this manually?
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