FDA-Device2014-11-12Class II
Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: 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 stab
Straumann USA, LLC
Hazard
Product transfer piece was fitted with a Narrow Connect (NC) instead of a Regular Connect (RC)
Sold states
US Nationwide Distribution
Affected count
111 units
Manufactured in
60 Minuteman Rd, N/A, Andover, MA, United States
Products
Straumann Bone Level Implant 04.1 mm RC, SLActive¿ 8mm, Roxolid¿, Loxim Article Number: 021.4308 Product Usage: 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. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0174-2015Don't want to check this manually?
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