NuSmile, Ltd.

FDA Regulatory Profile

NuSmile, Ltd. appears in FDA public data with 0 recalls, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on September 4, 2026.

Summary

Total Recalls
0
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K253909NeoPEX™ Pre-Mixed Obturation PasteSeptember 4, 2026
K181917MTA2.3 MATERIALSJanuary 11, 2019