Reported Sep 3, 2025 · Ongoing
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product…
Dentsply IH, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dentsply IH, Inc. · 590 Lincoln St · Waltham, MA · 02451-2173
Is this the product you have?
- Brand NameAtlantis
- IO FLO Product NameAtlantis
- IO FLO-S Kit Model/Catalog NumberA04S / 6802034
- Product DescriptionThe Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring chewing function in partial or complete edentulous patients, by enabling digital impression taking on implant or abutment level for all positions in the mouth of the patient or on the master model
- Componentnot a component
- Lot codes and dates
- Catalog / Ref #: 68020034
- UDI
07392532249440Lot #s: 10515863105120841050554310556741
- Amount recalled
- 780 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The threads will only engage approximately 2 rotations as opposed to full engagement which is approximately 5 rotations. This equates to approximately 1mm difference in depth of engagement.
This product could cause temporary or reversible health problems — stop using it.
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