FDA-Device2017-04-26Class II
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Instradent USA, Inc.
Hazard
During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.
Sold states
Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.
Affected count
170 pieces
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
NEODENT CM Intraoral Scanbody, Article Number: 108.139
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1831-2017Don't want to check this manually?
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