FDA-Device2018-05-16Class II
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
Straumann Manufacturing, Inc.
Hazard
A change regarding the shelf life of a raw material was implemented without an appropriate submission of data demonstrating the continued efficacy of the product.
Sold states
Distributed US Nationwide and Puerto Rico.
Affected count
3046
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1694-2018Don't want to check this manually?
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