Dentsply IH BV
Waltham, MA, US
DENTSPLY IH BV appears in FDA device records in Waltham, MA. FDA records list no 510(k) clearances, no PMA records and 3 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3011824442 | 3011824442 | DENTSPLY IH BV | Piri Reisweg 23, Sevenum Limburg 5975 RZ NL | 2026 | and 31 more, listed in full below |
| 1222802 | 1000120733 | DENTSPLY IH Inc. | 590 LINCOLN STREET, Waltham, MA 02451 US | 2026 | |
| 9612468 | 3002806429 | Dentsply IH AB | HELIUMGATAN 1, MOLNDAL Vastra Gotaland 431 53 SE | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- NDPAccessories, Implant, Dental, Endosseous
- EBZActivator, Ultraviolet, For Polymerization
- KLEAgent, Tooth Bonding, Resin
- EJTAlloy, Gold-Based Noble Metal
- EJHAlloy, Metal, Base
- EJXAnchor, Preformed
- KXRApplicator, Resin
- NPLBarrier, Animal Source, Intraoral
- GFABlade, Saw, General & Plastic Surgery, Surgical
- NPMBone Grafting Material, Animal Source
- LYCBone Grafting Material, Synthetic
- EKWBroach, Endodontic
- EMACement, Dental
- NRUChair, Dental, Without Operative Unit
- EMMChisel, Osteotome, Surgical
- EBWController, Foot, Handpiece And Cord
- EBGCrown And Bridge, Temporary, Resin
- ELZCrown, Preformed
- PNPDental Abutment Design Software For Dental Laboratory
- PEMDental Barriers And Sleeves
- EGSHandpiece, Contra- And Right-Angle Attachment, Dental
- EKXHandpiece, Direct Drive, Ac-Powered
- KMWHandpiece, Rotary Bone Cutting
- LXBHearing Aid, Bone Conduction
- MAHHearing Aid, Bone Conduction, Implanted
- DZEImplant, Endosseous, Root-Form
- EKDInstrument, Cutting, Operative
- DZNInstruments, Dental Hand
- LQYLocator, Root Apex
- EBFMaterial, Tooth Shade, Resin
- FWZOperating Room Accessories Table Tray
- JEYPlate, Bone
- EKNPoint, Paper, Endodontic
- EIHPowder, Porcelain
- EKQPreparer, Root Canal Endodontic
- EMEPunch, Biopsy, Surgical
- EBIResin, Denture, Relining, Repairing, Rebasing
- KIFResin, Root Canal Filling
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- FLESterilizer, Steam
- LLZSystem, Image Processing, Radiological
- FSMTray, Surgical, Instrument
- EFSUnit, Oral Irrigation
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2422-2025 | Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The 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. Component: not a component | 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. | Class II | Open, Classified | |
| Z-2421-2025 | Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The 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. Component: not a component | 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. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain