Brasseler USA I Lp

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1008-2024Class IIBrasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental bur, 10 burs/paJanuary 11, 2024
Z-0884-2020Class IIBrasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm ProDecember 11, 2019
Z-0591-2020Class IIBRASSELER KM166-310-35 Twist Drill Quick Connect Diameter 3.5 mm, Total Length 112mm, Effective LengOctober 18, 2019