Preat Corp

FDA Regulatory Profile

Summary

Total Recalls
11
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2514-2025Class IINobelBiocare Tri-Lobe-compatible WP X 6.0mm Engaging Titanium Base, REF: 9000662June 25, 2025
Z-2107-2025Class IIPreat, Astra EV-compatible 4.2mm Digital Analog REF: 9006603 (single) and 9006603-10(10 pack), Rx OJune 24, 2025
Z-1987-2025Class IIBiomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are iApril 2, 2025
Z-2687-2024Class IIMultiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatible 6.0mm Digital Analog,June 25, 2024
Z-2318-2024Class II9006767 Astra EV 4.8mm Milled Titanium Abutment Milled abutments are too be used in conjunction wApril 10, 2024
Z-1321-2024Class IIPreat Nobel Active/Conical-compatible RP Titanium Blank, REF 9000967February 9, 2024
Z-0154-2024Class IIPreat REF 9007124, Neodent GM x 4mm Healing Abutment (Wide), Rx Only, Non-Sterile, Single Use Only. July 18, 2023
Z-0153-2024Class IIPreat REF 9007123, Neodent GM x 4mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. DentalJuly 18, 2023
Z-0152-2024Class IIPreat REF 9007121, Neodent GM x 2mm Healing Abutment, Rx Only, Non-Sterile, Single Use Only. DentalJuly 18, 2023
Z-1285-2023Class IINeodent GM X 6mm Engaging Titanium Base, REF: 9007162February 21, 2023
Z-1226-2023Class IIIPREAT NOBIL GRIP, product numbers 0102000 and 01202000-3 (3 pack), 5-ml vials packaged in pouches, dFebruary 1, 2023

Recent 510(k) Clearances

K-NumberDeviceDate
K810977ENDODONTIC POST SYSTEMSMay 13, 1981