FDA-Device2014-12-31Class II
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achi
Instradent USA, Inc.
Hazard
Product not approved for use in the US
Sold states
Nationwide Distribution including AZ, CA, NY, and MA.
Affected count
13 units
Manufactured in
60 Minuteman Rd, Andover, MA, United States
Products
Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery. Dental implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0839-2015Don't want to check this manually?
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