FDA-Device2020-07-22Class II
DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
Neocis Inc.
Hazard
The LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled.
Sold states
US Nationwide distribution including in the states of AZ, CA, FL, NY, and NH
Affected count
70 units
Manufactured in
2800 Biscayne Blvd Ste 600, N/A, Miami, FL, United States
Products
DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2637-2020Don't want to check this manually?
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