FDA-Device2025-12-03Class IIMISBRANDING

Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

FALSE CLAIMSNationwide distributionMedical devices
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Hazard

The possibility for this product that is intended for demonstration purposes only to be placed in patients.

Intended for
Adults
Illnesses reported
None reported
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-0582-2026

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