FDA-Device2016-10-05Class II
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Prismatik Dentalcraft, Inc
Hazard
Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. Prismatik failed to properly identify the lots as quarantined product.
Sold states
Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
Affected count
150 units
Manufactured in
2181 Dupont Dr, N/A, Irvine, CA, United States
Products
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2897-2016Don't want to check this manually?
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