12 results
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33ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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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
WB Impression Post Closed Tray incl. guide screw, L 13mm, TAN/POM
FDA Enforcement
Class III
·Ongoing·Straumann USA LLC·February 18, 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
Plus Initial Drill, Article Number: 103.170;
FDA Enforcement
Class II
·Ongoing·Straumann USA LLC·June 4, 2025
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