7 results
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13ms
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Sources: EU EUDAMED, US FDA
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Enforcement
Class II
·Completed·Allied Vision Group Inc·May 6, 2020
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
FDA Enforcement
Class III
·Completed·STRATASYS LTD·July 16, 2025
Alcon Air Optix Night & Day Aqua (lotrafilcon A), breathable contact lenses, PWR - 1.50 BC 8.6 DIA 13.8, Rx, Sterile. The firm name on the label is Alcon Laboratories, Inc., Fort Worth, TX.
FDA Enforcement
Class II
·Completed·Lens.com·December 11, 2019