FDA-Device2014-10-29Class II
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 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.
Straumann USA, LLC
Hazard
Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
Sold states
US Distribution in states of: FL and MA.
Affected count
6 units
Manufactured in
60 Minuteman Rd, Andover, MA, United States
Products
Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021 .5308 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0117-2015Don't want to check this manually?
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