FDA-Device2025-04-02Class II
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Premier Dental Products Co
Hazard
The hardness not meeting the material specification and may cause the diamond bur to bend.
Sold states
US Nationwide distribution in the states of CA, MN, NY, PA, TN, VA, WA.
Affected count
77 units
Manufactured in
1710 Romano Dr, N/A, Plymouth Meeting, PA, United States
Products
Premier Solo Diamond - Large Invented Cone; SKU: 807016C.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1408-2025Don't want to check this manually?
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