FDA-Device2021-06-02Class II

NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352

Nobel Biocare Procera LLC
Hazard

Not manufactured to specification

Sold states
Worldwide distribution - US Nationwide distribution in the states of AL,CA, OK, WA and the countries of Belgium, Canada, Italy, Sweden, Switzerland.
Affected count
7 units
Manufactured in
800 Corporate Dr, N/A, Mahwah, NJ, United States
Products
NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1678-2021

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