11 results
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31ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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NobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662
FDA Enforcement
Class II
·Ongoing·Preat Corp·September 10, 2025
Preat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx Only
FDA Enforcement
Class II
·Ongoing·Preat Corp·July 16, 2025
Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations.
FDA Enforcement
Class II
·Ongoing·Preat Corp·June 25, 2025
9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
FDA Enforcement
Class II
·Ongoing·Preat Corp·July 17, 2024
Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog, REF 9000703 Straumann Tissue-Level-compatible WN Digital Analog, REF 9001303 3i Certain-compatible 5.0mm Digital Analog, REF 9001903 3i Certain-compatible 6.0mm Digital Analog, REF 9002003 Astra-compatible 3.0mm Digital Analog, REF 9002103 Astra-compatible Aqua 3.5/4.0mm Digital Analog, REF 9002203 Astra-compatible Lilac 4.5/5.0mm Digital Analog, REF 9002203 BioHorizons¿-compatible 3.0mm Digital Analog, REF 9005203 Legacy-compatible 3.0mm Digital Analog, REF 9005303 Digital Analog - BioHorizons - 3.5mm, Digital Analog - BioHorizons¿ - 4.5mnm, REF 9005403 Legacy-compatible 3.5mm Digital Analog, REF 9005503 Legacy-compatible 5.7mm Digital Analog, REF 9008503 Astra EV 4.8mm Milled Titanium Abutment REF 9006767 Digital analogs are used for visual inspection of abutments and restoration in the dental laboratory.
FDA Enforcement
Class II
·Ongoing·Preat Corp·August 28, 2024
Preat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967
FDA Enforcement
Class II
·Ongoing·Preat Corp·March 27, 2024
PREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dental anaerobic glue.
FDA Enforcement
Class III
·Ongoing·Preat Corp·March 15, 2023
Preat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
FDA Enforcement
Class II
·Ongoing·Preat Corp·November 1, 2023
Preat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. Dental
FDA Enforcement
Class II
·Ongoing·Preat Corp·November 1, 2023
Preat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. Dental
FDA Enforcement
Class II
·Ongoing·Preat Corp·November 1, 2023
Neodent GM X 6mm Engaging Titanium Base, REF: 9007162
FDA Enforcement
Class II
·Ongoing·Preat Corp·April 5, 2023