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Sagemax Bioceramics, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2356-2026Class IINexxZr T Multi A3.5 W98-16mm, REF: 745451December 11, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K130991NEXXZR(TM)T AND NEXXZR(TM)SFebruary 10, 2014
K062695SAGEMAX Z-BLANKOctober 20, 2006