FDA-Device2020-05-13Class II
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Nobel Biocare Usa Llc
Hazard
The top label of article no. 37965, lot 12129104 (immediate packaging of endosseous dental implants ) may incorrectly indicate an implant length of 7mm, which is shorter than the actual length of the implant (10mm).
Sold states
International distribution - the country Russia only.
Affected count
228 pieces
Manufactured in
22715 Savi Ranch Pkwy, N/A, Yorba Linda, CA, United States
Products
NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1851-2020Don't want to check this manually?
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