Dentsply IH, Inc.

FDA Regulatory Profile

Dentsply IH, Inc. appears in FDA public data with 2 recalls, 0 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2421-2025, Class II) was initiated on July 24, 2025.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2421-2025Class IIBrand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 680July 24, 2025
Z-2422-2025Class IIBrand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 68020July 24, 2025