FDA-Device2025-12-03Class II
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Straumann USA LLC
Hazard
The possibility for this product that is intended for demonstration purposes only to be placed in patients.
Sold states
US Nationwide distribution in the states of AZ, CA, DE, FL, ID, MO, TN, TX, UT, VA.
Affected count
61 units
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0582-2026Don't want to check this manually?
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