Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Dentsply SironaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Dentsply IH, Inc. with 2 device recalls. The most recent is a device recall dated Jul 24, 2025: Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: ….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 24, 2025 | Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis inClass II · The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used | Device recalls |
| Jul 24, 2025 | Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product DeClass II · The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
