Zentek Medical, LLC

FDA Regulatory Profile

Zentek Medical, LLC appears in FDA public data with 0 recalls, 3 510(k) clearances, 1 FDA inspection, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Oct 15, 2025.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K251294Bonafix Implant AbutmentsOct 15, 2025
K221673Bonafix TiBaseJul 14, 2023
K213677Bonafix 2 PlusDec 20, 2022