FDA-Device2023-04-05Class II
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Preat Corp
Hazard
Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.
Sold states
US Nationwide distribution in the states of TX, OR, UT, NY.
Affected count
26
Manufactured in
2625 Skyway Dr Ste B, N/A, Santa Maria, CA, United States
Products
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1285-2023Don't want to check this manually?
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