FDA-Device2021-02-03Class II

DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

Neocis, Inc.
Hazard

The LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled.

Sold states
OH, FL, CT, MA, AZ PA, NY
Affected count
100 units
Manufactured in
530 NW 29th St, Miami, FL, United States
Products
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0929-2021

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