18 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304. Endosseous Dental Implant Abutments
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·May 6, 2026
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158. Endosseous Dental Implant Abutments
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·May 6, 2026
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·April 1, 2026
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·April 1, 2026
Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·December 3, 2025
GM Helix Acqua Implant, Article Number: 140.985
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·June 4, 2025
GM Helix Acqua Implant, Article Number: 140.984
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·June 4, 2025
WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·April 30, 2025
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
FDA Enforcement
Class II
·Terminated·Straumann USA LLC·January 26, 2022
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
FDA Enforcement
Class II
·Terminated·Straumann USA LLC·January 26, 2022
Plus Initial Drill, Article Number: 103.170;
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·June 4, 2025
Straumann Narrow CrossFit (NC) Screw for CARES Abutment ZrO2. Endosseous dental implant Article Number: 027.2650 Product Usage: Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations using a Straumann Narrow CrossFit CARES ZrO2 Abutment in edentulous or partially edentulous patients. 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 a Straumann Narrow CrossFit CARES ZrO2 abutment is attached by screw to the dental implant. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, four or more implants must be used.
FDA Enforcement
Class II
·Terminated·Straumann USA, LLC·August 15, 2012
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.
FDA Enforcement
Class II
·Terminated·Straumann USA, LLC·October 29, 2014
Drill set long, drill stop compatible for 4.8mm diameter implant, Article Number 040.447S Endosseous dental implant drill set.
FDA Enforcement
Class II
·Terminated·Straumann USA, LLC·January 21, 2015
Straumann SCS Screwdriver, driver, for ratchet, short, L 21mm, stainless steel Article Number: 046.401. dental surgical instrument.
FDA Enforcement
Class II
·Terminated·Straumann USA LLC·August 11, 2021
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
FDA Enforcement
Class II
·Terminated·Straumann USA, LLC·November 12, 2014
KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·September 1, 2021
TLX/TLC SP Guided Implant Driver, for ratchet, stainless steel; REF: 037.3002;
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·April 23, 2025