FDA-Device2024-02-14Class II
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Brasseler USA I Lp
Hazard
The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
Sold states
Worldwide - US Nationwide distribution in the states of AL, CA, CO, DC, IL, NY, OH, OR, PA, TN, TX, and WA. The country of Canada.
Affected count
440 burs
Manufactured in
1 Brasseler Blvd, Savannah, GA, United States
Products
Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/package, Rx.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1008-2024Don't want to check this manually?
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